ABSTRACT
OBJECTIVES: The evidence demonstrating the efficacy of photobiomodulation (PBM) therapy for preventing and managing acute radiation dermatitis (ARD) is growing steadily. The question that arises from many clinicians is, if PBM is safe for oncologic patients. This study aimed to evaluate the disease-free survival (DFS), cancer-free survival (CFS), and overall survival (OS) of breast cancer patients treated with PBM for ARD. METHODS: Clinical data of 120 breast cancer patients treated with prophylactic PBM (n = 60, 2x/week, 808-905 nm, 4 J/cm2 ) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During follow-up (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the first 5 years after the end of RT. The DFS, CFS, and OS were estimated. RESULTS: At a median follow-up time of 66 months (range 4-81), there was no significant difference in DFS (73.7% vs. 98.3%, resp., p = 0.54), CFS (68.4% vs. 77.8%, resp., p = 0.79), and OS (87.9% vs. 98.3%, resp., p = 0.30) between the placebo and PBM group. CONCLUSIONS: This paper is the first to describe the results of a long-term follow-up in early-stage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not influence the locoregional recurrence, the development of new primary tumors, or OS.
Subject(s)
Breast Neoplasms , Radiodermatitis , Humans , Female , Breast Neoplasms/radiotherapy , Breast Neoplasms/pathology , Follow-Up Studies , Retrospective Studies , Radiodermatitis/etiology , Radiodermatitis/prevention & control , Radiodermatitis/radiotherapyABSTRACT
OBJECTIVE: Acute radiation dermatitis (ARD) is a frequent adverse effect in patients with cancer undergoing radiotherapy (RT). The aim of this case series is to evaluate the effect of a novel skin barrier protectant in patients with ARD. METHODS: The skin barrier protectant was used in four patients with different cancer types undergoing RT at two clinical sites. All patients received the standard institutional skincare alongside the novel skin barrier protectant. The skin reactions were evaluated by an RT nurse using the modified version of the Radiation Therapy Oncology Group criteria. RESULTS: At the final RT session, three of four patients developed erythema with or without dry desquamation. One patient presented only a minor patchy moist wound. Overall, the pain and pruritus due to ARD was low or nonexistent. No adverse events related to the skin barrier protectant were reported. CONCLUSIONS: This case series demonstrates the beneficial effects and safety of the novel skin barrier protectant in the management of ARD in patients with cancer of different etiologies. These results lay the foundation for future studies with larger, more homogeneous patient populations; a well-defined application scheme; and a stricter study design.
Subject(s)
Breast Neoplasms , Radiodermatitis , Female , Humans , Radiodermatitis/drug therapy , Radiodermatitis/prevention & control , Skin CareABSTRACT
The objective of this retrospective analysis was to determine the incidence and extent of vaginal mucositis (VM) in women with gynaecological cancer undergoing external (chemo)radiation therapy (CRT). A retrospective analysis was set up to collect data on the incidence and severity of VM in women treated with external pelvic RT for gynaecological cancer at the Jessa Hospital, Hasselt and ZOL, Genk, BE between January 2017 and June 2018. At the start and end of their external (C)RT, they rated the frequency and intensity of five common symptoms of VM. Thirty-three patients treated with RT for gynaecological cancer met the inclusion criteria. A non-negligible proportion of patients already experienced at least one VM symptom to any degree before the start of RT, a proportion that further increased towards the end of the RT (73%). At the end of RT, on average, about 25% of these patients reported moderate-to-severe symptoms (against about 7% before the (C)RT). These results suggest that VM is a rather frequent side effect in gynaecological cancer patients that aggravates during treatment up to a moderate severity level. Although the small sample size, these data highlight the need for attention to VM.Impact StatementWhat is already known about this topic? Radiotherapy plays an important role in the treatment of gynaecological malignancies. A debilitating complication in patients undergoing pelvic radiotherapy is vaginal mucositis, an inflammation of the vaginal mucosal lining. To date, the incidence of vaginal mucositis is still not well documented.What this paper adds? A non-negligible proportion of patients already experienced at least one symptom related to vaginal mucositis before the start of radiotherapy. Most patients presented mild to moderate vaginal mucositis symptoms at the end of external pelvic radiotherapy. Burning sensation, pruritus, and pain were the most frequently documented radiotherapy-induced complications.The implications of this paper: Vaginal mucositis is an underrated side effect of pelvic radiotherapy that needs to be tackled multidisciplinary by a team of nurses, radiotherapists, oncologists, and gynaecologists. The team should tackle the complication from the start of radiotherapy by using the most appropriate measures. Due to a possible link between acute vaginal mucositis and late vaginal toxicity, the team needs to follow-up patient's post-radiotherapy to support patients in late complications and advise/encourage patients in performing vaginal dilatation to prevent vaginal stenosis.
Subject(s)
Genital Neoplasms, Female , Head and Neck Neoplasms , Mucositis , Radiation Injuries , Chemoradiotherapy/adverse effects , Constriction, Pathologic/etiology , Female , Genital Neoplasms, Female/drug therapy , Genital Neoplasms, Female/radiotherapy , Humans , Mucositis/complications , Mucositis/etiology , Radiation Injuries/epidemiology , Radiation Injuries/etiology , Retrospective Studies , VaginaABSTRACT
OBJECTIVES: To evaluate the efficacy of photobiomodulation therapy in breast cancer patients post-lumpectomy undergoing hypofractionated whole-breast irradiation (HF-WBI) for the prevention and management of acute radiodermatitis (ARD). MATERIALS AND METHODS: A randomized, multicentric clinical trial (LABRA trial, NCT03924011) was set up at the Limburg Oncology Center, including the Jessa Hospital (Hasselt, BE) and Ziekenhuis Oost-Limburg (Genk, BE). A total of 71 breast cancer patients planned to undergo HF-WBI were randomized to one of the two study arms: the control group (n = 32) or the PBM group (n = 39). The PBM group received the standard institutional skincare combined with PBM (2×/week) during the complete radiotherapy (RT) course. Patients in the control group received the standard skincare combined with placebo treatment (2x/week). Patients' skin reactions were evaluated weekly during the RT treatment by using the modified version of the Radiation Therapy Oncology Group (RTOG) criteria. RESULTS: At week 3 of RT, one patient presented a grade 2 and one patient a grade 3 skin reaction in the control group, while in the PBM group, all patients still presented grade 1 ARD. At the final RT session 28% of the patients presenting grade 2-3 ARD, while in the PBM group 10% presented grade 2 and no grade 3 ARD. PBM reduced the incidence of severe ARD by 18%. However, the difference was not significant (p = 0.053). CONCLUSION: Based on the LABRA trial results, PBM seems not able to reduce the incidence of severe ARD in breast cancer patients undergoing HF-WBI. Research in a larger patient population is recommended.
Subject(s)
Breast Neoplasms , Low-Level Light Therapy , Radiodermatitis , Breast , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Female , Humans , Low-Level Light Therapy/methods , Radiodermatitis/etiology , Radiodermatitis/prevention & control , Radiodermatitis/radiotherapyABSTRACT
BACKGROUND AND PURPOSE: The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. MATERIALS AND METHODS: A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2×/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. RESULTS: PBMT significantly reduced NCI-CTCAE grade 2-3 ARD with 49% at the end of RT. CONCLUSION: The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology - radiotherapy practice.
Subject(s)
Head and Neck Neoplasms , Low-Level Light Therapy , Radiodermatitis , Head and Neck Neoplasms/radiotherapy , Humans , Radiodermatitis/etiology , Radiodermatitis/prevention & controlABSTRACT
OBJECTIVE: To evaluate the use of a novel skin barrier protectant in a patient treated with radiotherapy for vulvar cancer. METHODS: This case report was conducted in a radiotherapy department with two women undergoing radiotherapy for vulvar carcinoma. A novel skin barrier protectant was evaluated in one patient; the other underwent the institutional standard skin care protocol. Skin reactions and pain were evaluated using the Radiotherapy Oncology Group Criteria. MAIN RESULTS: The patient who was treated with the skin protectant showed accelerated healing toward the end of radiotherapy, and this was accompanied with a decrease in pain (maximum pain score 6/10). In comparison, the patient treated with the standard skin care protocol had an extended healing process, experienced a higher pain level (maximum pain score 9/10), and required more nursing care. CONCLUSIONS: This case report is the first to suggest that this novel skin barrier protectant could effectively manage acute radiodermatitis in patients with cancer. This case report hopes to lay the foundation for future randomized controlled trials with a larger and broader patient population.
Subject(s)
Architectural Accessibility/standards , Radiodermatitis/drug therapy , Skin Care/standards , Vulvar Neoplasms/drug therapy , Aged , Aged, 80 and over , Architectural Accessibility/statistics & numerical data , Belgium , Female , Humans , Skin Care/methods , Skin Care/statistics & numerical data , Vulva/drug effects , Vulva/physiopathologyABSTRACT
The aim of this Letter to the Editor was to report some methodological shortcomings in the recently published article "Application of red light phototherapy in the treatment of radioactive dermatitis in patients with head and neck cancer" by Zhang et al. There are some issues regarding the incomplete photobiomodulation (PBM) parameters, the chosen outcome measures, and some missing reference articles. In conclusion, the results of this study should be interpreted with caution and further research is necessary.
Subject(s)
Dermatitis , Head and Neck Neoplasms , Humans , Phototherapy , PrognosisABSTRACT
PURPOSE: The purpose of this study was to evaluate objectively the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) by using biophysical skin measurements. METHODS: A randomized, placebo-controlled trial with 120 breast cancer patients who underwent an identical radiotherapy (RT) regimen post-lumpectomy was performed (TRANSDERMIS trial). Patients were randomized to receive PBM (808 nm CW/905 nm pulsed, 168 mW/cm2, spot size 19.6 cm2, fluence 4 J/cm2) or placebo treatments from the first day of RT (2×/week). Biophysical skin measurements were collected to assess the skin pigmentation and barrier function. Measurements were collected at the first day of RT, a RT dose of 40 Gray (Gy), and the end of RT (66 Gy). RESULTS: The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004). The biophysical skin measures showed that the mean percentage change from the baseline transepidermal water loss (TEWL), erythema, and melanin values was significantly higher in the control than in the PBMT group at the end of RT (ps < 0.05). Logistic regression analysis revealed that the risk on moist desquamation was significantly increased for patients with a large (> 800 cc) breast volume (odds ratio = 4, p = 0.017). CONCLUSIONS: This is the first randomized controlled trial demonstrating by objective measurements that PBMT is effective in reducing the incidence of moist desquamation in breast cancer patients undergoing RT. Additionally, a large breast volume is an important risk factor for the development of moist desquamation.
Subject(s)
Breast Neoplasms/radiotherapy , Low-Level Light Therapy/methods , Radiodermatitis/diagnosis , Radiodermatitis/prevention & control , Secondary Prevention/methods , Skin/chemistry , Acute Disease , Adult , Aged , Biophysical Phenomena , Breast/abnormalities , Breast Neoplasms/diagnosis , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Combined Modality Therapy , Female , Humans , Hypertrophy , Mastectomy, Segmental/adverse effects , Middle Aged , Prognosis , Radiotherapy, Adjuvant , Risk Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Acute radiodermatitis (RD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute RD in breast cancer (BC) patients undergoing RT. METHODS: This study was a randomized, placebo-controlled trial including 120 BC patients that underwent an identical RT regimen post-lumpectomy. Patients were randomly assigned to the laser therapy (LT) or placebo group, with 60 patients in each group. Laser or placebo treatments were applied 2 days a week, immediately after the RT session, starting at the first day of RT. PBMT was delivered using a class IV MLS® M6 laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2 ). Skin reactions were scored based on the criteria of the Radiation Therapy Oncology Group (RTOG) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The patients completed the Skindex-16 questionnaire to evaluate their quality of life. All the measurements were collected at the first day, at a RT dose of 40 Gray (Gy), and at the end of RT (total dose 66 Gy). RESULTS: At a RT dose of 40 Gy, there was no significant difference between the groups in the distribution of RTOG grades. However, at the end of RT the severity of the skin reactions significantly differed between the two groups (P = 0.004), with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g., moist desquamation) in the placebo group (30% vs. 6.7%, for the placebo and laser group, resp.). The objective RISRAS score confirmed these results. In addition, the Skindex-16 and RISRAS subjective score demonstrated that the patients' quality of life was significantly better in the LT than in the control group. CONCLUSIONS: The results of this trial show that PBMT is an effective tool to prevent the development of grade 2 acute RD or higher in BC patients. In addition, it also reduces the patients' symptoms related to RD. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.