Clinical trial · Interventional
Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers
Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers - a Randomized, Controlled, Two-armed Intervention Study
NCT03162289CI-TRIAL-00062644FIT2unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting | Other | — | UNRESOLVED |
| Vegan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fasting
- description
- 60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy)
- interventionNames
- Other: Fasting
- type
- ACTIVE_COMPARATOR
- label
- Vegan
- description
- 60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy)
- interventionNames
- Other: Vegan
Primary outcomes (1)
- measure
- FACT-G
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Diagnosed, gynecological, malignant tumor disease (non-metastatic ovarian or breast cancer). Other inclusion criteria: * Age 18-75 years * Cancer is treated conventionally with an adjuvant or neo-adjuvant protocol with at least 4 CT cycles The following CTs are considered for breast carcinoma: * \- (EC, Sparano) 4 x Epirubicin and Cyclophosphamide, followed by 12 cycles Paclitaxel weekly * \- (AC, Henderson) 4 x Doxorubicin, cyclophosphamide, followed by 4 cycles Docetaxel every three weeks 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: * Reduction in CT dose compared to usual dosage * Excessive underweight (BMI \<19kg / m2) or actual weight reduction \> 3kg or \> 5kg in the last 1 or 3 months. * Pre-existing eating disorder (Anorexia nervosa, Bulimia) * Renal insufficiency (creatinine\> 2mg / dl) * Severe disease or other disease with a significant reduction in mobility and overall vitality * Diabetes mellitus * No inclusion in other study protocol * Lack of email address and Internet access (due to electronic CRF)
References
Publications (1)
- DERIVEDKoppold-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. PMID 33059765