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

NorthShore University HealthSystem

Status: Not yet enrolling

Conditions: Chemotherapeutic Toxicity; Ovarian Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Dietary Supplement: Standard diet; Dietary Supplement: Fasting Mimicking Diet (Xentigen by L'Nutra)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05921149

EH22-383

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Carboplatin and paclitaxel with standard diet

Active Comparator group

Description:

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.

Treatment:

Drug: Paclitaxel

Dietary Supplement: Standard diet

Drug: Carboplatin

Carboplatin and paclitaxel with fasting mimicking diet (FMD)

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Fasting Mimicking Diet (Xentigen by L'Nutra)

Drug: Paclitaxel

Drug: Carboplatin