Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression.
Chemotherapy (CT) is a basic element in the therapy of gynecological oncologic diseases besides surgery, antibody therapy, anti-hormonal therapy and radiation. The chemotherapeutic intervention can be experienced physically and psychologically as a severe stress due to unwanted acute and also relevant long term side effects. It is even possible that because of severe side effects the CT can not be continued and main goals of the therapy like tumor reduction or elimination can not be achieved. Except of some medicinal approaches (such as antiemetics) or therapeutic exercise, not many therapeutic approaches are known to help reduce CT induced side effects. Against this background it is important to identify and scientifically evaluate new approaches to reduce the side effects of CT. The aim of this study is to verify the effectiveness of intermittent fasting as a potentially helpful supportive therapy in CT. In a prior pilot study of our institute with 34 breast- and ovarian cancer patients showed beneficial effects of an intermittent fasting of 72-84 h parallel to the application of the CT (manuscript submitted in Cancer Science).
The results of this confirmatory study are therefore of potentially high clinical relevance for all chemotherapeutically treated patients.
Long term goal: This study can lead to the improvement of tolerance and effectiveness of chemotherapeutic tumor therapy through accompanying intense nutritional therapy interventions. Beyond that it can be the starting point of a following multi-center randomized controlled study.
A large variety of animal experimental studies as well as three smaller pilot studies suggest that intermittent fasting can reduce the unwanted side effects of CT and enhance the quality of life. It is being speculated that the anti-tumor effect of fasting is enhanced through the reduction of the Insulin-like growth factor-1 (IGF-1) and mTOR as well as p53-signalling molecules (differential stress resistance).
But it is still unclear whether the possible beneficial effect that intermittent fasting shows can only be reached by subtotal caloric restriction or a significant reduction of the intake of animal proteins and refined sugar could also cause a similar decrease in IGF-1.
Against this background this confirmatory study aims to test the hypothesis that CT in the adjuvant and neoadjuvant treatment of breast- and ovarian cancer is better tolerable under intermittent fasting than under a normo-caloric vegan and sugar-reduced diet.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting | Active Comparator | 60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy) |
|
| Vegan | Active Comparator | 60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting | Other | Patients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists. |
| Measure | Description | Time Frame |
|---|---|---|
| FACT-G | Summarized change of FACT-G score | Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remissions | Number of histologically proven complete remissions (ypT0ypN0 bzw. ypT0/is) after neoadjuvant CT | From date of randomization until the date of surgery |
| Millar Payne classification |
| Measure | Description | Time Frame |
|---|---|---|
| Trial outcome index score (TOI) | TOI | Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| Total AC (FACT-B/FACT-O) |
Diagnosed, gynecological, malignant tumor disease (non-metastatic ovarian or breast cancer).
Other inclusion criteria:
The following CTs are considered for breast carcinoma:
If the recruitment rate is not reached, further CT protocols can be accepted.
CT for patients with ovarian cancer: According to current protocols, at least 4 planned cycles. For the study a maximum of 8 cycles are considered (except therapy with Taxol).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Study Principal Investigator Charite | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert-Ludwigs-University of Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79085 | Germany | ||
| Klinikum Ludwigsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33059765 | Derived | Koppold-Liebscher D, Kessler CS, Steckhan N, Bahr V, Kempter C, Wischnewsky M, Hubner M, Kunz B, Paul M, Zorn S, Sari S, Jeitler M, Stange R, Michalsen A. Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Oct 15;21(1):854. doi: 10.1186/s13063-020-04700-9. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vegan | Other | Patients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists. |
|
Histological classification according to Millar Payne scale
| after surgery/histological examination, an average 6 months after intervention start |
According to kind of cancer (breast cancer/ ovarian cancer) |
| Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| FACIT-F | Fatigue | Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| FACT-Tax,FACT/GynecologicOncologyGroup-Ntx | Specific chemotherapy induced effects on quality of life and neurologic symptoms | Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| Chemotherapy-Induced Peripheral Neuropathy Assessment Tool | Chemotherapy-Induced Peripheral Neuropathy Assessment Tool | Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| Hospital Anxiety and Depression Scale | Hospital Anxiety and Depression Scale | Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| Side effects of CT | Likert scales | Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
| Weight | Documentation according to the standard documentation rules of the German Tumour Centres Work Group, Weight in kilograms | Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
| BMI | Documentation according to the standard documentation rules of the German Tumour Centres Work Group, BMI in kg/m^2 | Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
| Blood panel | Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units | Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
| Blood values for liver function | Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units | Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
| Blood values for renal function (Krea, Hst.) | Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units | Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
| IGF-1, Insulin, Blood glucose | Explorative measurements in blood samples in subgroup of 20 patients | Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start |
| Long-term explorative measurements: frequency of recurrence | Information taken from the documentation of the treatment, visits and questionnaires | 1, 2 and 3 years after baseline |
| Long-term explorative measurements: e.g. polyneuropathy, cardiomyopathy | Information taken from the documentation of the treatment, visits, questionnaires and interview | 1, 2 and 3 years after baseline |
| ketone bodies | Explorative measurements in capillary blood, only in subpopulation of n=20 | Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start |
| Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE) | Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE)" | Baseline, 3 weeks after end of CT, 1,2,3 years after baseline |
| Qualitative interviews in focus groups | Qualitative interviews in focus groups | Baseline, 6 months |
| Ludwigsburg |
| Baden-Wurttemberg |
| 71640 |
| Germany |
| Ernst-von-Bergmann Klinikum, Klinik für Gynäkologie und Geburtshilfe | Potsdam | Brandenburg | 14467 | Germany |
| Brustzentrum Charite Campus Mitte | Berlin | 10117 | Germany |
| Vivantes Brustzentrum | Berlin | 10967 | Germany |
| Charité Virchow Klinikum | Berlin | 13353 | Germany |
| Brustzentrum Krankenhaus Waldfriede | Berlin | 14163 | Germany |
| Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus | Berlin | 14163 | Germany |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |