Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEndeavor Health
About this trial
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
Qualifiers
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).
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Fasting Mimicking Diet (Xentigen by L'Nutra)
- Carboplatin
- Paclitaxel
- Standard diet
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Endeavor Health
Lead sponsor
L-Nutra Inc
Collaborator
Source ClinicalTrials.gov