Impact of Short Term Fasting on Chemotherapy Side Effects in Breast Cancer Patients
Fasting Diet and Chemotherapy Toxicity
This study is testing if a short-term fasting diet can help reduce side effects from chemotherapy in breast cancer patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Thessaly Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tríkala, Thessaly) |
| Trial ID | NCT06015087 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a short-term fasting diet on chemotherapy-induced toxicities in breast cancer patients. Participants will be randomly assigned to either a fasting diet group, which will undergo a 60-hour fasting period around their chemotherapy sessions, or a control group following a standard diet. The intervention group will also be encouraged to adopt a Mediterranean diet during their chemotherapy cycles. The study aims to assess the feasibility of this dietary approach and its influence on the severity of chemotherapy side effects.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients with a first diagnosis, no distinct metastasis, and who are scheduled to receive at least four cycles of chemotherapy.
Not a fit: Patients with a BMI under 19, significant recent weight loss, or a history of eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the side effects of chemotherapy, improving the quality of life for breast cancer patients.
How similar studies have performed: While the concept of dietary interventions during chemotherapy is being explored, this specific approach of short-term fasting has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * breast cancer patients with first diagnosis of breast cancer * no distinct metastasis * patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy Exclusion Criteria: * BMI\<19kg/m2 * unintentional weight loss of \>3 or \>5 kg the last 3 or 6 months respectively * medical history of anorexia nervosa, boulimia or any other eating disorders * renal failure (creatinine \>2mg/dl) * diabetes mellitus (type I or Insulin dependent type II) * serious psychiatric disease * serious cardiovascular disease * mobility limitations * being participant in any other study
Where this trial is running
Tríkala, Thessaly
- Department of Nutrition-Dietetics — Tríkala, Thessaly, Greece (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.