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

• Status: Not yet recruiting
• Trial end date: 2031-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed.

Short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to FMD or regular diet during chemotherapy, less antiemetic was required in the FMD group; radiographic and pathologic responses were better in this group.

This trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and/ or improved tumor response to therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem
• Collaborator: L-Nutra Inc
• Treatments: Carboplatin; Paclitaxel

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)