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

University of Thessaly

Status: Enrolling

Conditions: Fasting, Diet, Chemotherapy, Toxicity

Treatments: Other: fasting diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06015087

Fasting diet

Details and patient eligibility

About

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 of 60 hours (36h prior chemotherapy and 24h after the end of chemotherary), while the control group will follow regular (standard) diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet.

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.

Full 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.

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention group

Experimental group

Treatment:

Other: fasting diet

Control group

No Intervention group