Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients

Phase

N/A

Condition

N/A

Treatment

fasting diet

Clinical Study ID

NCT06015087

Fasting diet

Ages 18-75
Female
Accepts Healthy Volunteers

Study Summary

The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.

Eligibility Criteria

Inclusion

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

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

Study Design

fasting diet

July 01, 2022

July 31, 2024

Study Description

This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet for 60 hours (36h prior chemotherapy and 24h after the end of chemotherapy), while the control group will follow regular diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet. The patients will be randomized in the two groups. A total of 50 patients is required. Biochemical data, anthropometric measures and grading of toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events, nutritional habits, adherence to the Mediterranean diet (implementation of MedDietScore) will be assessed prior, during and after the intervention, in both groups. Nutritional counseling will be performed by Registered Dietitian, and telephone interviews will be used to record adherence to fasting diet and Mediterranean diet.