Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: Fasting mimicking diet with 2 grams W3 will be administered three days prior to and the day of chemotherapy. Fasting mimicking diet is a plant-based diet providing
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to participate in the study 2. The WHO performance state 0 to 2 3. Adequate bone marrow function 4. Normal kidney, liver and heart function
Exclusion criteria
Exclusion criteria: Diabetes or any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods. Significant food allergies which would make the subject unable to consume the food provided More than 10% weight loss in the last 3 months Pregnancy or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IGF-1, IGFBP3, Glucose, Insulin. Timepoint: Before intervention and the end of last chemotherapy cycle. Method of measurement: Valid laboratory kits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of quality of life, Efficacy of chemotherapy. Timepoint: For quality of life: Before intervention, mid time of chemotherapy, end of chemotherapy. For efficacy of chemotherapy: at the end of chemotherapy. Method of measurement: For quality of life: European Organization for Research and Treatment of Cancer quality of life questionnaire core-30 and European Organization for Research and Treatment of Cancer quality of life questionnaire breast cancer-23. For efficacy of chemotherapy: Radiological response and pathological response. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEhsan Hejazi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed