Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
Ovarian Cancer, Chemotherapeutic Toxicity
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years All patients with advanced ovarian, fallopian tube and primary peritoneal carcinomas deemed appropriate candidates for neoadjuvant chemotherapy and patients with recurrent, platinum-sensitive disease (as defined by an interval of at least 6 months following completion of last platinum-based chemotherapy prior to disease relapse or progression) ECOG Performance Status of 0, 1 or 2. Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L and platelet count ≥100 x 109/L). Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN). Adequate hepatic function defined as: Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN BMI ≥19 kg/m2 Exclusion Criteria: Patients with malnutrition and/ or BMI <19 Patients with active eating disorders (as identified by history of pre-enrollment nutrition screen) Diabetes mellitus requiring medication management (both insulin and non-insulin requiring). Patients with diabetes mellitus controlled by diet alone (i.e. patients not requiring anti-glycemic medications) are NOT excluded and are eligible for participation. Allergy to component of fasting mimicking diet (FMD) Patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas with relapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)
Sites / Locations
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Carboplatin and paclitaxel with standard diet
Carboplatin and paclitaxel with fasting mimicking diet (FMD)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A standard diet is consumed throughout each cycle of therapy.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A fasting mimicking diet (FMD) is consumed beginning 3 days prior to chemotherapy and on the day of chemotherapy (days -2, -1, 0 and 1 of each cycle).