Decrease of radiation-induced skin reactions in breast cancer patients by preventive application of film dressings-a systematic review.

PURPOSE: Radiation-induced skin reactions remain one of the most frequent side effects of adjuvant radiotherapy for breast cancer, which is the most common global malignancy. In individual cases, we observed a decrease in radiation dermatitis under film dressings used for skin marking purposes. Therefore, we decided to revise the available evidence regarding the prophylactic use of film dressings to reduce radiation dermatitis in breast cancer patients. METHODS: On 20 March 2023, we conducted a systematic review of literature for randomized controlled trials published in the English, German, French, or Spanish language, available in the PubMed database. RESULTS: Of 82 publications, 9 full texts were assessed and 6 randomized controlled trials were included in the final synthesis. Two trials analyzed the application of polyurethane film (Hydrofilm, Paul Hartmann AG, Heidenheim, Germany), the other four of silicone-based polyurethane film (Mepitel film, Molnlycke Health Care Limited, Milton Keynes, United Kingdom). The evaluation scales Common Terminology Criteria for Adverse Events (CTCAE), Radiation Therapy Oncology Group (RTOG), and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS) were used for assessment. All six trials, with a total of 788 patients yielding data for analysis, demonstrate a significant decrease in radiation-induced skin reactions by use of the film (mainly p < 0.001). CONCLUSION: Our analysis demonstrates a significant decrease in radiation-induced skin reactions by prophylactically applied film dressings in breast cancer patients. Consequent preventive use of film dressings might systematically reduce acute radiation-induced skin reactions in these patients.

Real-time definition of single seed placement sensitivity in low-dose-rate prostate brachytherapy.

PURPOSE: In low-dose-rate brachytherapy, iodine-125 seeds are implanted based on a treatment plan, generated with respect to different dose constraints. The quality of the dose distribution depends on a precise seed placement, however, during treatment planning the impact on the dose parameters when certain seeds fail to be placed precisely is not clear. METHODS AND MATERIALS: We developed a method using automatic differentiation to calculate gradients of dose parameters with regard to the seeds' positions. Thus, we understand their sensitivity with respect to the seed placement. A statistical analysis is performed on a data set with 35 prostate brachytherapy patients. RESULTS: The most sensitive seeds regarding the dosimetric parameters of both rectum and urethra are close to the corresponding organ. Their gradient directions are mainly orthogonal to their surfaces. However, not all seeds close to the surface are equally sensitive with regard to the dose parameter. The most sensitive seeds regarding the prostate's dose parameters are distributed throughout the prostate and the direction of the gradients are mainly parallel to its surface. A linear regression with respect to different patient parameters shows that dose constraints which are barely fulfilled have large gradients and thus are additionally sensitive to misplacement. CONCLUSION: Automatic differentiation can be used to analyze dose parameter sensitivity with respect to seed placement. Integrating this into treatment planning systems is valuable as it speeds up the planning procedure, making it more robust and less dependent on user experience while showing the operating physician which needle placements require greater accuracy than others.

Do breast cancer patients adapt CAM methods according to the therapeutic situation?

BACKGROUND: and purpose: Complementary and alternative medicine (CAM) is frequently used among cancer patients. It is unclear whether and how far patients adapt CAM to the treatment situation. The objective is to assess the changes of CAM use between radiotherapy for breast cancer and the follow-up. MATERIALS AND METHODS: 107 patients who participated in a study assessing the possible effects of vitamin D and selenium on radiation-induced skin toxicity completed the CAM-PRIO (Working Group for Prevention and Integrative Oncology of the German Cancer Society) questionnaire during and after radiotherapy. The results were compared. RESULTS: Overall, 79.8% of the patients used at least one CAM method. Supplementation with vitamin D (49.4%) and selenium (28.7%) and prayer (37.1%) were the methods most used. After completing radiotherapy, many patients started using selenium, vitamin D, relaxation techniques, and yoga to a greater extent. Prior chemotherapy or concurrent endocrine treatments were not associated with the changes in CAM use. CONCLUSION: CAM use is mainly reported to be a static phenomenon. However, this study shows that this is not the case and that after the end of radiotherapy patients started using new CAM methods or increased the number of methods used.

Quality of life after pulmonary stereotactic fractionated radiotherapy (SBRT): Results of the phase II STRIPE trial.

BACKGROUND AND PURPOSE: Preserving health related quality of life (HRQOL) plays an important role in considering stereotactic body fractionated radiotherapy (SBRT). The prospective monocenter phase II STRIPE trial investigated long-term HRQOL after SBRT, efficacy and toxicity. MATERIALS AND METHODS: Patients with ≤2 pulmonary lesions ≤5 cm were treated with 4DPET/CT-based SBRT (3 × 12.5 Gy or risk-adapted 5 × 7 Gy, to 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then 3-monthly for 2 years with assessment of response (primary endpoint: 2-year cumulative incidence of local progression (LP); secondary endpoints: local progression free survival (LPFS), overall survival (OS) and toxicity (CTCAE)). Impact of predefined patient and treatment related factors on HRQOL (EORTC QLQ-C30 and EORTC QLQ-LC13) was evaluated. RESULTS: Between 02/2011 and 11/2014, 100 patients were given SBRT for 56 NSCLC and 44 pulmonary metastases (M1). Long-term FU overall revealed stable Quality of Life (QoL)/Global health status (GHS), functions-scores and symptoms. For QoL/GHS, patients with low (

Vitamin D and selenium blood levels and acute skin toxicity during radiotherapy for breast cancer.

OBJECTIVES: Vitamin D blood levels have been shown to influence acute chemotherapy toxicities. Therefore, it was investigated whether it is an intrinsic factor influencing acute skin toxicity in patients receiving radiotherapy for breast cancer. DESIGN/SETTING: In a total of 107 patients receiving radiotherapy for resected breast cancer, vitamin D and selenium blood levels were determined. Correlations between these levels and skin toxicity due to radiotherapy (CTC scores, Skindex scores) were investigated as primary endpoints. Furthermore, the statistical relationship between skin toxicity, vitamin D and selenium blood levels with patient and disease characteristics such as tumor stage, breast size, skin thickness, blood cell counts as well as individual quality of life measured by SEIQoL-Q was analyzed. MAIN OUTCOME MEASURES/RESULTS: In our patient collective large deficiencies of vitamin D (mean level 20.9 ng/ml, normal range 36-60 ng/ml) and selenium (mean level 76.1 µg/l, normal range 74-139 µg/l) were found. No correlations between skin toxicities, vitamin D and selenium blood levels were found. Neither did these blood levels correlate with any tumor or patient characteristics nor with individual quality of life. As expected by clinical experience, skin toxicities correlated significantly with breast size and skin thickness. CONCLUSIONS: In this study, radiotherapy skin toxicity was not influenced by vitamin D or selenium blood levels. On the basis of our data we cannot recommend vitamin D or selenium supplementation as a prophylaxis for skin toxicity. Nevertheless, large numbers of breast cancer patients have substantial deficiencies of both substances. Therefore, supplementation may be reasonable for other reasons.

Stereotactic body radiotherapy dose and its impact on local control and overall survival of patients for locally advanced intrahepatic and extrahepatic cholangiocarcinoma.

PURPOSE: Non-resectable cholangiocarcinoma (CCC) is a significant therapeutic challenge because of bad prognosis. This study analyzed the outcome after SBRT for intra- and extrahepatic CCC. MATERIAL AND METHODS: Sixty-four patients with 82 CCC lesions from a retrospective multicenter database were analyzed. Available parameters were analyzed for local control (LC), overall survival (OS) and toxicity. RESULTS: Median follow-up time for patients alive was 35 months (range 7-91 months). Median overall survival (OS) time was 15 months; 2-year and 3-year OS rates were 32% and 21%. Median prescribed biological effective radiation dose (BED, α/ß = 10) was 67.2 Gy10 (range, 36-115 Gy10; SD: 20 Gy10) in median 8 fractions (range, 3-17; 95% CI: 3-12), median BEDmax was 91 Gy10. BED was the only prognostic factor for LC and OS. Patients receiving BEDmax >91 Gy10 had a median OS of 24 months vs. 13 months for those receiving lower doses (p = 0.008). LC rates at 12 and 24 months were 91% and 80% for BEDmax >91 Gy10 vs. 66% and 39% for lower doses (p = 0.009). Of note, tumor size and PTV were neither predictive nor prognostic for LC and OS. Treatment tolerance was good with 17% of grade 1 gastroduodenitis, 11% of grade 2-3 cholangitis and 4.7% of grade 3 gastrointestinal bleeding. CONCLUSION: This is the largest reported series on SBRT in cholangiocarcinoma. Overall survival and local control were significantly improved after higher doses (BED) and tolerance was excellent.

Honey in the management of side effects of radiotherapy- or radio/chemotherapy-induced oral mucositis. A systematic review.

BACKGROUND: and purpose: In spite of several trials, systematic reviews and meta-analyses, honey is not considered as a viable candidate for the prophylaxis and treatment of radiotherapy-induced oral mucositis in the practice guidelines for supportive care. The purpose of this study was to analyse the value of honey in this treatment situation based on randomized trials acknowledging the fact that manuka honey which is used in some trials distinguishes itself from other honey due to the presence of methylglyoxal. METHODS: On the basis of a literature search, we identified and analysed 17 randomized trials on the topic. Participants in these trials received radiotherapy or a combination of radiotherapy and chemotherapy for head and neck cancer. RESULTS: Studies using manuka honey found little rationale for the medicinal use of honey (n = 4) in this field, whereas trials using conventional honey presented data on its usefulness (n = 13). Thus, the type of honey may explain the divergent results of trials in this area. CONCLUSION: Conventional honey is likely to be effective in the prophylaxis and treatment of radiation- and chemoradiation-induced oral mucositis.

Early Impact of Pulmonary Fractionated Stereotactic Body Radiotherapy on Quality of Life:Benefit for Patients With Low Initial Scores (STRIPE Trial).

INTRODUCTION: Quality of life (QoL) of comorbid patients with pulmonary malignancies is a key issue in considering fractionated stereotactic body radiotherapy (SBRT) indication. This study investigates the early impact of SBRT on QoL. METHODS: One hundred patients with pulmonary lesions were treated with SBRT from February 2011 to December 2014 within the prospective, monocenter, phase II STRIPE trial. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core module (EORTC QLQ-C30) and the QLQ-LC13 lung cancer-specific questionnaire were used to evaluate QoL before, 2 and 7 weeks after SBRT, then every 3 months for 2 years. We report on the analysis of early changes from baseline to 7-week follow-up exam. Impact of patient- and treatment-related factors on the change in QoL was analyzed. RESULTS: QoL was assessed in 97 patients; compliance was 92% and 85% at baseline and 7 weeks after SBRT, respectively. No clinically relevant changes greater than or equal to 10 in the QoL/global health status (GHS), function scores and inquired symptoms were observed. Patients with baseline QoL below the median showed clinically relevant improvement in QoL/GHS (Δ16.7 ± 25.3, p = 0.003), emotional function (Δ14.4 ± 25.4, p = 0.013), and fatigue (Δ -10.1 ± 26.5, p = 0.089) in contrast to patients with high initial scores. No changes were observed in the dichotomized subgroups of initial Karnofsky index, Charlson Comorbidity Index, age, diagnosis, and tumor localization. CONCLUSIONS: In short-term follow-up, QoL is well maintained after pulmonary SBRT. Especially patients with low initial QoL/GHS scores show benefit from SBRT with respect to QoL.

Tidying rooms and tending hearts: An explorative, mixed-methods study of hospital cleaning staff's experiences with seriously ill and dying patients.

BACKGROUND/AIM: Palliative care is based on multi-professional team work. In this study, we investigated how cleaning staff communicate and interact with seriously ill and dying patients as well as how cleaning staff cope with the situation of death and dying. DESIGN: Sequential mixed methods, consisting of semi-structured interviews, focus groups, and a questionnaire. Interviews and focus group discussions were content analyzed and results were used to create a questionnaire. Quantitative data were submitted to descriptive analysis. SETTING: Large university clinic in southern Germany. PARTICIPANTS: A total of 10 cleaning staff participated in the interviews and 6 cleaning staff took part in the focus group discussion. In addition, three managerial cleaning staff participated in a separate focus group. Questionnaires were given to all cleaning staff ( n = 240) working at the clinic in September 2008, and response rate was 52% (125/240). RESULTS: Cleaning staff described interactions with patients as an important and fulfilling aspect of their work. About half of participants indicated that patients talk with them every day, on average for 1-3 min. Conversations often revolved around casual topics such as weather and family, but patients also discussed their illness and, occasionally, thoughts regarding death with cleaning staff. When patients addressed illness and death, cleaning staff often felt uncomfortable and helpless. CONCLUSION: Cleaning staff perceive that they have an important role in the clinic-not only cleaning but also supporting patients. Likewise, patients appreciate being able to speak openly with cleaning staff. Still, it appears that cleaning staff may benefit from additional training in communication about sensitive issues such as illness and death.

Venous thromboembolism and persistent pulmonary hypertension in cancer patients: a cross-sectional study.

BACKGROUND: Cancer patients are at increased risk for venous thromboembolism (VTE). OBJECTIVE: This monocenter cross-sectional study prospectively assessed the association between a history of ≥1 VTE episode and the presence of pulmonary hypertension (PH) among cancer patients presenting with pulmonary or cardiac symptoms. METHODS: A consecutive series of 583 patients underwent a diagnostic work-up for heart and lung disease. PH was diagnosed if a patient's peak systolic pressure gradient across the tricuspid valve was ≥35 mmHg, as measured by echocardiography. Using multiple logistic regression analysis, the association between VTE and PH was assessed, following adjustments for age, the presence of severe airway obstruction, atrial fibrillation and left heart diseases. RESULTS: The prevalence values for PH (n = 90) and a history of VTE (n = 72) were 15.4 and 12.3 %, respectively. The median time interval between the first VTE episode and referral was 43 months. The odds of PH was higher in the subgroup with VTE (19/72; 26.4 %) than that without VTE (71/511; 13.9 %) in the unadjusted analysis [odds ratio (OR) 2.2, 95 % confidence interval (CI) 1.2, 4.0] and the adjusted model [OR 2.4, 95 % CI 1.2, 4.5]. The risk of PH did not depend on the time interval between VTE and referral. Older age and the presence of severe airway obstruction, atrial fibrillation, and left heart diseases were also associated with an increased odds of PH. CONCLUSION: In cancer patients presenting with cardiac or pulmonary symptoms, previous VTE is associated with an increased risk of persistent PH.

Limitations of N-Terminal Pro-B-Type Natriuretic Peptide in the Diagnosis of Heart Disease among Cancer Patients Who Present with Cardiac or Pulmonary Symptoms.

OBJECTIVES: Recognizing heart disease is relevant to oncologists because cancer patients are at an increased risk of cardiac mortality due to shared risk factors and the adverse effects of cancer therapy. This study assessed the extent to which the measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) aids in the diagnosis of heart disease in addition to a history of coronary artery disease and the presence of atrial fibrillation (composite test). The NT- proBNP cutoff value was 100 pg/ml. METHODS: A series of 583 consecutive cancer patients (68.4 ± 11.0 years) who were referred because of cardiac or pulmonary symptoms prospectively underwent a diagnostic work-up. Heart disease was diagnosed if at least one of the following conditions was present: (a) history of coronary artery disease, (b) atrial fibrillation, (c) impaired left ventricular systolic function, (d) significant valvular disease, (e) pulmonary hypertension, or (f) left ventricular hypertrophy. RESULTS: Except for (a), all 6 conditions were associated with NT-proBNP >100 pg/ml. The sensitivity/specificity values of the composite test were 0.92/0.50 for any heart disease. Several extracardiac covariates were associated with NT-proBNP >100 pg/ml, which contributed to the low test specificity. CONCLUSIONS: The low specificity of NT-proBNP limits its value for the diagnosis of heart disease in cancer patients.

Radiation recall dermatitis after docetaxel chemotherapy. Treatment by antioxidant ointment.

Radiation recall dermatitis (RRD) is an acute skin toxicity caused by different anticancer or antibiotic drugs within a former completely healed irradiation field. Predictive factors for RRD are not known and its mechanisms are not completely understood. A case of RRD induced by docetaxel and successfully treated by an antioxidant ointment (Mapisal(®)) is presented here. Such an ointment might be useful not only in RRD therapy, but also in the treatment of high-grade dermatitis induced by radiotherapy and thus may contribute to the improvement of patients' quality of life and to the scheduled completion of cancer therapies.

Measuring individual quality of life in patients receiving radiation therapy: the SEIQoL-Questionnaire.

PURPOSE: Quality of life (QoL) is one of the most important outcomes in cancer care. Although a number of instruments to measure health-related QoL (HRQoL) exist, there are few suitable instruments to measure individual QoL. The best established instrument is the Schedule for the Evaluation of Individual Quality of Life (SEIQoL). The disadvantage of this questionnaire is its use of semi-structured interviews, which are very time-consuming. The purpose of our study was to transform the SEIQoL into an economical instrument that can be used in clinical trials with large samples. METHODS: We developed the SEIQoL-Questionnaire (SEIQoL-Q) on the basis of the SEIQoL-Direct Weighting (SEIQoL-DW) by transforming the interview guide into a written questionnaire. Patients (N = 1,108) in all three phases of radiation treatment (first consultation, ongoing irradiation, and aftercare) were asked to complete the SEIQoL-Q and the European Organization for Research and Treatment of Cancer QLQ-C30. RESULTS: While the average HRQoL measured by the QLQ-C30 was 55.6, the average SEIQoL-Q index was 59.6. The most important life domain was "physical health," followed by "emotional well-being" and "family." Patients attributed the highest level of satisfaction to "home/housing," followed by "family" and "partnership." Male patients were shown to have a significantly better QoL than females. The SEIQoL-Q index correlates moderately with the QLQ-C30 functioning scale "global quality of life" [r = .42 (p < .001)]. CONCLUSIONS: According to our findings, the SEIQoL-Q appears to be a feasible and economical instrument for use in quantitative research among cancer patients in different stages of their disease.

Cardiotoxicity and cancer therapy: treatment-related cardiac morbidity in patients presenting with symptoms suggestive of heart or lung disease.

OBJECTIVES: Cardiac injury is one of the complications of cancer treatment. This study aimed to investigate the relationships between the types of radiotherapy of the chest (RT), chemotherapy (CT), cancer surgery (CS) and endocrine therapy (ET), and the presence of heart disease, and their associations with the serum level of N-terminal pro-B-type natriuretic peptide (NT-proBNP). METHODS: A consecutive series of 374 patients with cancer who were referred because of symptoms suggestive of heart or lung disease prospectively underwent a diagnostic workup. RESULTS: The prevalence of heart disease was 36.9%. RT administered before 1995 (n = 19) was associated with both increased odds of heart disease [adjusted odds ratio 10.3, 95% confidence interval 3.1-34.0] and higher ln-transformed NT-proBNP values (p < 0.01) compared to the control group (no RT or RT for right-sided breast cancer from 1995 onwards; n = 311). Anthracycline-treated patients (n = 54) had higher adjusted values for ln(NT-proBNP) compared to the control group (no CT; n = 243; p < 0.01) but no increased odds of heart disease. CONCLUSIONS: While pre-1995 RT and anthracycline-containing CT were associated with cardiac effects, there was no evidence that RT using modern cardioprotective techniques, CT in the absence of anthracyclines, CS or ET had detrimental effects on the heart.

Radiotherapy for prevention and therapy of gynecomastia due to antiandrogen treatment in prostate cancer patients: a patterns-of-care study.

BACKGROUND: Gynecomastia is a frequent side effect of antiandrogen therapy for prostate cancer and may compromise quality of life. Although it has been successfully treated with radiotherapy (RT) for decades, the priority of RT as a preferred treatment option has recently been disputed as tamoxifen was also demonstrated to be effective. The aim of the present paper is to provide an overview of indications, frequency, and technique of RT in daily practice in Germany, Switzerland, and Austria. PATIENTS AND METHODS: On behalf of the DEGRO-AG GCG-BD (German Cooperative Group on Radiotherapy of Benign Diseases) a standardized questionnaire was sent to 294 RT institutions. The questionnaires inquired about patient numbers, indications, RT technique, dose, and - if available - treatment results. Moreover, the participants were asked whether they were interested in participating in a prospective study. RESULTS: From a total of 294 institutions, 146 replies were received, of which 141 offered RT for gynecomastia. Seven of those reported prophylactic RT only, whereas 129 perform both preventive and symptomatic RT. In 110 of 137 departments, a maximum of 20 patients were treated per year. Electron beams (76%) were used most often, while 24% of patients received photon beams or orthovolt x-rays. Total doses were up to 20 Gy for prophylactic and up to 40 Gy for therapeutic RT. Results were reported by 19 departments: prevention of gynecomastia was observed in 60-100% of patients. Only 13 institutions observed side effects. CONCLUSION: Prophylactic and symptomatic RT is widely used in the German-speaking countries, but patient numbers are small. The clinical results indicate that RT is a highly effective and well-tolerated treatment.

[Survey of potential improvements during the course of the radiotherapy treatment--a patient questionnaire]. / Erfassung möglicher Verbesserungen im Ablauf der Strahlentherapie--eine Patientenbefragung.

INTRODUCTION AND BACKGROUND: In the context of quality assurance, increasing demands are placed on the whole radiotherapy treatment process. The patients directly concerned generally do not realize most aspects of the quality assurance program (e.g., additional safety checks) during their daily therapy. It was the aim of this study to systematically ask patients about potential improvements during the course of radiotherapy treatment from their own perspective. PATIENTS AND METHODS: In the defined time span (1 month), 624 radiotherapy patients (600 questionnaires were returned, 96.2%) were interviewed using a questionnaire newly developed to inquire about several aspects of their treatment. Furthermore, they were asked for their specific needs and suggestions for improvements that could be made during the course of radiotherapy treatment. RESULTS: Overall, the patients were satisfied with the course of their radiotherapy treatment and with patient care. As an example, about 90% agreed with the statement: "My first contact with the radiation oncology unit proceeded with kindness and competence so that I was given the impression that I will be well cared for in this clinic." Considering the organization of the course of radiotherapy, a large majority of patients attached great value to set appointments for the therapy fractions. A main point of criticism was waiting times or delays caused by servicing or machine failures. Small, low cost improvements as music in the therapy room were considered as important as expensive measures (e.g., daylight in the therapy room). The patients emphasized the importance of staff friendliness. CONCLUSION: The situation of radiotherapy patients was, in general, satisfactory. Future improvements can be mainly expected from smooth organisation of both planning and treatment which can be achieved by electronic scheduling systems. Many results of the survey could be easily implemented in daily practice. In matters of organization radiation oncology with its complex procedures can be used as a model for other clinical departments.

Determination of major boswellic acids in plasma by high-pressure liquid chromatography/mass spectrometry.

Until now, dexamethasone is the medication of choice to reduce peritumoral edema associated with primary and secondary brain tumors. Because of the severe side effects accompanying such a treatment the interest in alternative agents that may be co-administered with glucocorticoids and help to reduce the required dose is constantly increasing. Boswellia serrata gum resin extracts (BSE), which have been designated an orphan drug status by the European Medicines Agency (EMA) in 2002 for the treatment of peritumoral edema, may represent a promising supplemental herbal remedy. However, clinical studies on the effect of BSE on brain edema as well as analyzes of serum levels are very scarce. Based on that background a prospective, placebo controlled, and double blind clinical pilot trial was conducted on 14 patients applying for the first time a high dose of 4200 mg BSE per day and 13 patients receiving placebo. For monitoring the serum levels of all major boswellic acids (BAs) a highly sensitive HPLC-MS method has been developed that allows the determination of KBA and AKBA from 5.0 ng/ml to 3000 ng/ml and of αBA, ßBA, AαBA and AßBA from 0.5 ng/ml to 12,000 ng/ml. It is the first validated method that covers such a wide concentration range, which makes it suitable to be used as standard method in clinical trials as it compensates for the great pharmacokinetic variability in the plasma levels of BAs observed in clinical practice. Average steady concentrations (ng/ml) in the range of 6.4-247.5 for KBA, 0-15.5 for AKBA, 36.7-4830.1 for αBA, 87.0-11948.5 for ßBA, 73.4-2985.8 for AαBA and 131.4-6131.3 for AßBA were determined in the verum group. The here quantified steady state levels suggest ßBA to be a possible candidate for the anti-inflammatory and anti-edemateous effects of BSE. In general, the serum level analysis underlines the promising clinical results of BSE on cerebral edema.

Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial.

BACKGROUND: Patients irradiated for brain tumors often suffer from cerebral edema and are usually treated with dexamethasone, which has various side effects. To investigate the activity of Boswellia serrata (BS) in radiotherapy-related edema, we conducted a prospective, randomized, placebo-controlled, double-blind, pilot trial. METHODS: Forty-four patients with primary or secondary malignant cerebral tumors were randomly assigned to radiotherapy plus either BS 4200 mg/day or placebo. The volume of cerebral edema in the T2-weighted magnetic resonance imaging (MRI) sequence was analyzed as a primary endpoint. Secondary endpoints were toxicity, cognitive function, quality of life, and the need for antiedematous (dexamethasone) medication. Blood samples were taken to analyze the serum concentration of boswellic acids (AKBA and KBA). RESULTS: Compared with baseline and if measured immediately after the end of radiotherapy and BS/placebo treatment, a reduction of cerebral edema of >75% was found in 60% of patients receiving BS and in 26% of patients receiving placebo (P = .023). These findings may be based on an additional antitumor effect. There were no severe adverse events in either group. In the BS group, 6 patients reported minor gastrointestinal discomfort. BS did not have a significant impact on quality of life or cognitive function. The dexamethasone dose during radiotherapy in both groups was not statistically different. Boswellic acids could be detected in patients' serum. CONCLUSIONS: BS significantly reduced cerebral edema measured by MRI in the study population. BS could potentially be steroid-sparing for patients receiving brain irradiation. Our findings will need to be further validated in larger studies.