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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- 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)
- ECOG Performance Status of 0, 1 or 2.
- Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L andplatelet count ≥100 x 109/L).
- Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN).
- Adequate hepatic function defined as: Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN
- BMI ≥19 kg/m2
Exclusion
Exclusion Criteria:
- Patients with malnutrition and/ or BMI <19
- Patients with active eating disorders (as identified by history of pre-enrollmentnutrition screen)
- 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.
- Allergy to component of fasting mimicking diet (FMD)
- 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 StatesSite Not Available
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