Clinical trial NCT06015087: Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients
Official title: Fasting Diet and Chemotherapy Toxicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fasting, Diet, Chemotherapy, Toxicity
Keywords: fasting diet, breast cancer, chemotherapy toxicity, Mediterranean Diet
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
timeFrame: The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.
Secondary outcomes:
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: Department of Nutrition-Dietetics
state: Thessaly
Study officials:
References: