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

Last updated: May 5, 2024
Sponsor: NorthShore University HealthSystem
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vaginal Cancer

Ovarian Cancer

Pelvic Cancer

Treatment

Fasting Mimicking Diet (Xentigen by L'Nutra)

Standard diet

Paclitaxel

Clinical Study ID

NCT05921149
EH22-383
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years
  2. All patients with advanced ovarian, fallopian tube and primary peritoneal carcinomasdeemed appropriate candidates for neoadjuvant chemotherapy and patients withrecurrent, platinum-sensitive disease (as defined by an interval of at least 6 monthsfollowing completion of last platinum-based chemotherapy prior to disease relapse orprogression)
  3. ECOG Performance Status of 0, 1 or 2.
  4. Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L andplatelet 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

Exclusion Criteria:

  1. Patients with malnutrition and/ or BMI <19
  2. Patients with active eating disorders (as identified by history of pre-enrollmentnutrition screen)
  3. Diabetes mellitus requiring medication management (both insulin and non-insulinrequiring). Patients with diabetes mellitus controlled by diet alone (i.e. patientsnot requiring anti-glycemic medications) are NOT excluded and are eligible forparticipation.
  4. Allergy to component of fasting mimicking diet (FMD)
  5. Patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas withrelapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)

Study Design

Total Participants: 170
Treatment Group(s): 4
Primary Treatment: Fasting Mimicking Diet (Xentigen by L'Nutra)
Phase:
Study Start date:
May 25, 2024
Estimated Completion Date:
June 01, 2031

Connect with a study center

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

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