Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer

Launched by ENDEAVOR HEALTH · Jun 25, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special diet called the Fasting Mimicking Diet (FMD) can help reduce the side effects of chemotherapy in women with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The chemotherapy drugs used in this trial are carboplatin and paclitaxel, which can sometimes cause severe side effects. Previous studies suggest that short-term fasting may protect patients from these toxic effects while still allowing the chemotherapy to work effectively. By combining the FMD with chemotherapy, researchers hope to see if this approach can lead to fewer side effects and better responses in treating the cancer.

To participate in this trial, women aged 18 and older who are receiving chemotherapy for advanced or recurrent ovarian cancer may be eligible. Key requirements include having a good performance status, meaning they can carry out daily activities, and having stable blood counts and organ function. Participants will follow the FMD during their chemotherapy treatment, and the trial is designed to monitor how well they respond to the therapy and how well they tolerate the side effects. If you are interested or think you might qualify, please talk to your doctor for more information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. 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)
• • 3. ECOG Performance Status of 0, 1 or 2.
• • 4. Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L and platelet count ≥100 x 109/L).
• • 5. Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN).
• 6. Adequate hepatic function defined as:
• • Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN
• • 7. BMI ≥19 kg/m2
• Exclusion Criteria:
• • 1. Patients with malnutrition and/ or BMI \<19
• • 2. Patients with active eating disorders (as identified by history of pre-enrollment nutrition screen)
• • 3. 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.
• • 4. Allergy to component of fasting mimicking diet (FMD)
• • 5. 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)