Do we have predictors of therapy responsiveness for a multimodal therapy concept and aerobic training in breast cancer survivors with chronic cancer-related fatigue?

Cancer-related fatigue (CRF) is a burdensome symptom for breast cancer (BC) patients. In this pilot study, we tested several questionnaires as predictors for treatment responsiveness, along with the implementation of a multimodal therapy concept consisting of sleep, psycho-education, eurythmy, painting therapy and standard aerobic training. At the Community Hospital Havelhöhe and the Hannover Medical School, 31 BC patients suffering from CRF could be evaluated in a 10-week intervention study. CRF was assessed by the Cancer Fatigue Scale (CFS-D). Further questionnaires were the Pittsburgh Sleep Quality Index, the autonomic regulation scale, Self-Regulation Scale (SRS), the Internal Coherence Scale (ICS) and the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale. We estimated the regression coefficients of all scales on CFS-D by simple and multiple linear regression analyses and compared regression slopes and variances between the different questionnaires on CFS-D at the end of treatment. We found a significant impact of SRS and ICS at baseline on CFS-D at the end of the intervention [absolute standardised multiple regression coefficient values ranging from 0.319 (SRS) to 0.269 (ICS)] but not for the other questionnaires. In conclusion, this study supports the hypothesis that the SRS or ICS measuring adaptive capacities could be more appropriate as outcome predictors than classical questionnaire measures in complex interventions studies.

Impact of autonomic and self-regulation on cancer-related fatigue and distress in breast cancer patients--a prospective observational study.

PURPOSE: Cancer-related fatigue (CRF) has a major impact on the quality of life in breast cancer patients (BC). So far, only a few prospective studies have investigated the effect of adaptive salutogenic mechanisms on CRF. The aim of our study was to evaluate the possible prospective influence of autonomic Regulation (aR) and self-regulation (SR) on CRF and distress in long-term survivors. METHODS: 95 BC and 80 healthy female controls (C) had been included in the observational study between 2000 and 2001 and completed the questionnaires on aR, SR and Hospital Anxiety and Depression Scale (HADS). Of these, 62 BC, and 58 C participated in the re-evaluation 6.6 years later: 16 participants were deceased (14 BC and 2 C). During follow-up, participants were requested to answer questions involving (Cancer Fatigue Scales) CFS-D, aR, SR and HADS. Multiple regression analysis was used to evaluate the influence of aR, SR, age, Charlson co-morbidity-index and diagnosis on CFS-D and HADS, and to select further potentially relevant factors. RESULTS: High aR values showed significant effects, namely inverse relationships with CFS-D, cognitive fatigue, anxiety and depression. SR showed a reduced influence on anxiety and depression (all p < 0.05). CONCLUSIONS: Autonomic regulation might have an independent, reductive influence on global fatigue, cognitive fatigue and--together with self-regulation--it seems to have a protective influence on anxiety and depression. The connection between these parameters is still unclear and awaits further evaluation. IMPLICATION FOR CANCER SURVIVORS: AR seems to be a prognostic factor in breast cancer survivors, capable of reducing cancer-related fatigue and self-regulation distress as well. Further research is necessary in order to show how aR can be improved by therapeutic interventions.

Validation of the State Version Questionnaire on Autonomic Regulation (State-aR) for cancer patients.

OBJECTIVES: Current quality of life inventories used in oncology mainly measure the effects of chemo- or radiotherapy alongside functional and role scales. A new approach is to measure the autonomic state of regulation with the trait-inventory of autonomic regulation (Trait-aR). Loss of Trait-aR has been shown in different medical conditions such as breast cancer (BC) but not in colorectal cancer patients (CRC). In this paper we report the validation of a new state autonomic regulation scale (State-aR) of the last week. METHODS: Study 1 included 114 participants: (41 women/16 men with cancer and 57 age- and gender-matched healthy people) to conduct a reliability-, factor- and validity-analysis. Concurrent and convergent validity was evaluated with Trait-aR, Fatigue-Numerical-Scale, Hospital Anxiety and Depression Scale (HADS-D) and the self-regulation scale, 65 participants were retested. Study 2 completed 42 participants: 17 with BC and 25 with CRC receiving chemotherapy. The State-aR was administered prior, during and after chemotherapy for measuring responsiveness. RESULTS: The factor analysis loaded to four subscales of State-aR (rest-activity, orthostatic-circulatory, thermo-sweating and digestive regulation) with a: Cronbach-α r(α) = 0.77?0.83 and a test-retest-reliability r(rt) = 0.60?0.80. The sum- and subscales correlated with their concurrent subscales in the Trait-aR (0.48?0.74) and with the sum-scale moderately with all convergent criteria (r = 0.41?-0.44; p <0.001). During chemotherapy the State-aR-sum and rest-activity-scale decreased significantly compared to the change in the Trait-aR (p <0.05). CONCLUSIONS: These findings support that the state autonomic regulation scale has satisfactory to good reliability, good validity and acceptable responsiveness in the context of chemotherapy treatment.

Quality of life in breast cancer patients during chemotherapy and concurrent therapy with a mistletoe extract.

BACKGROUND: The effects of standardized aqueous mistletoe extracts on Health Related Quality of Life (HRQoL) of tumor patients needs further evaluation. METHODS: in this non-interventional, prospective clinical investigation the longitudinal course of Quality of Life of 270 breast cancer patients during adjuvant chemotherapy and mistletoe therapy with abnobaVISCUM(®) Mali was investigated. HRQoL was measured 4 times by self-assessment with the QLQ-C30 and QLQ-BR23 questionnaire of the European Organization for Research and Treatment of Cancer (EORTC): at the beginning of mistletoe- and chemotherapy, 4 weeks later, at the end of the chemotherapy and 4 weeks after finishing chemotherapy. Secondary objectives were the tolerability and safety of mistletoe therapy in combination with chemotherapy under conditions of daily practice. RESULTS: after an initial deterioration the average range of all obtained QLQ-C30 function scales (n=262, 48.9-71.5) remained stable even at the last chemotherapy cycle and improved significantly (p<0.0001) to 66.9-80.7 4 weeks later, compared to the initial visit. Also the QLQ-BR23 function scales significantly improved (p<0.0001) 4 weeks later. The symptom scales of the QLQ-C30 remained stable under chemotherapy even at the final chemotherapy cycle and decreased from 16.2 to 44.1 at the initial visit to 11.2-29.9 (p<0.001) at the final visit. These results were comparable to the subgroup with initial visit before chemotherapy (n=114) in which rather stable function scales during chemotherapy (difference of the mean values: 9.6 to -3.7) and only little increase of symptoms (difference: 13.2 to -4.9) was measured. The tolerability of the therapy was judged by the physicians as good or very good for 91% of the patients and the efficacy was rated as good or very good for 94%. 89% of the patients reported about a good or very good benefit. CONCLUSION: the overall results point to a relevant stabilisation of Health Related Quality of Life during various chemotherapy regimes, possibly due to a reduction of chemotherapy caused side effects with an excellent tolerability of the mistletoe therapy.

Validation of the self regulation questionnaire as a measure of health in quality of life research.

OBJECTIVES: Several epidemiological studies address psychosomatic self regulation as a measure of quality of life aspects. However, although widely used in studies with a focus on complementary cancer treatment, and recognized to be associated with better survival of cancer patients, it is unclear what the self regulation questionnaire exactly measures. DESIGN AND SETTING: In a sample of 444 individuals (27% healthy, 33% cancer, 40% other internal diseases), we performed reliability and exploratory factor analyses, and correlated the 16-item instrument with external measures such as the Hospital Anxiety and Depression Scale, the Herdecke Quality of Life questionnaire, and autonomic regulation questionnaire. RESULTS: The 16-item pool had a very good internal consistency (Cronbach's alpha = 0.948) and satisfying/good (r subsetrt = 0.796) test-retest reliability after 3 months. Exploratory factor analysis indicated 2 sub-constructs: (1) Ability to change behaviour in order to reach goals, and (2) Achieve satisfaction and well-being. Both sub-scales correlated well with quality of life aspects, particularly with Initiative Power/Interest, Social Interactions, Mental Balance, and negatively with anxiety and depression. CONCLUSIONS: The Self Regulation Questionnaire (SRQ) was found to be a valid and reliable tool which measures unique psychosomatic abilities. Self regulation deals with competence and autonomy and can be regarded as a problem solving capacity in terms of an active adaptation to stressful situations to restore well-being. The tool is an interesting option to be used particularly in complementary medicine research with a focus on behavioural modification.

Validation of the German version of the Cancer Fatigue Scale (CFS-D).

Fatigue is a very important factor determining the quality of life in patients with malignancies. Cancer fatigue occurs with anaemia, during and after chemo- or radiotherapy and in patients with advanced tumours. The Cancer Fatigue Scale (CFS) is a three-dimensional inventory with 15 items which was originally developed in Japan. We present the results of a validation study of the German version (CFS-D) of this instrument. The CFS-D was administered to 114 participants in a matched-pair study. In total, 57 (41 women) of the participants had malignant conditions, and 57 (41 women) were healthy volunteers. The Fatigue Numerical Scale was used to test convergence. The physical and performance status of the cancer patients was assessed by the Karnofsky-Index. Criteria for testing multidimensionality were the Hospital Anxiety and Depression Scale, and the questionnaire on autonomic regulation. We generated a three-dimensional inventory of the CFS-D with the subscales physical fatigue/vitality, cognitive and affective fatigue. The reliability results for the complete scale: Cronbach's alpha: r(alpha) = 0.94, retest reliability: r(rt) = 0.82. The convergence criteria correlate between r = 0.44-0.65 (all P < 0.001). The CFS-D is highly reliable and has construct validity in relation to other measures.

[Blood and tissue eosinophilia, mistletoe lectin antibodies and quality of life in a breast cancer patient undergoing intratumoral and subcutaneous mistletoe therapy]. / Blut- und Gewebseosinophilie, Mistellektin-Antikörper und Lebensqualität bei einer Mammakarzinom-Patientin unter intratumoraler und subkutaner Misteltherapie.

BACKGROUND: Mistletoe therapy (MT) is a method of complementary medicine whose efficacy is controversially discussed. Until now there is a lack of data of high-dose intratumoral application. PATIENT AND METHODS: We are presenting a 3-year follow-up of an 80-year-old woman with metastasized breast cancer (c(2)T3/N1/M1) receiving combined intra- and peritumoral and subcutaneous MT with ABNOBAviscum(r) and concomitant pamitron acid. At time of admission the patient had bone metastases (thoracic vertebra 11 fracture), a lymphangiosis carcinomatosa, bilateral pleural effusions, and a reduced quality of life (QoL). RESULTS: Under MT we induced an eosinophilia and an elevation of eosinophil cationic protein (ECP). Simultaneously, we ascertained a reduction of 50% of Ca 15-3 and a sustained partial tumor remission. After 5 months the mistletoe-lectin-1 antibodies IgG-1 and -3 were maximally increased and we perceived a second Ca 15-3 reduction. After 3 months we observed a benefit in QoL. During the following 5 months the patient gained about 10 kg in weight. In the second year slow tumor progress was observed. After 19 months the patient had pneumonia which caused an MT pause. Subsequently, a combined intratumoral mistletoe and letrozol therapy brought a partial remission. The patient lived without chemo and radiation therapy more than 3 years with good QoL and died after 41 months, after a sepsis and a following stroke without signs of tumor progress. CONCLUSION: In metastasized breast cancer a palliative high-dose local MT can make a contribution to a tumor reduction and a benefit in QoL.

[Primary amyloidosis presenting as intrahepatic cholestasis (author's transl)]. / Intrahepatische Cholestase als Leitsymptom einer primären Amyloidose

In a 37-year-old female patient with marked signs of cholestasis and excessive hyperbilirubinaemia without any recognisable cause, the unexpected diagnosis of massive amyloidosis of the peri-collagenous and perireticular type was made after hepatic needle biopsy. There were also amyloid deposits in the rectal mucosa and in the bone marrow. Fifteen months after the onset of disease symptoms the patient died from the consequences of spontaneous intrahepatic haemorrhage. At the post-mortem investigation generalised amyloidosis with massive involvement of nearly all organs was found. Primary amyloidosis should be considered in the differential diagnosis of any aetiologically unexplained cholestasis.