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Trial Title:
Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
NCT ID:
NCT05921149
Condition:
Ovarian Cancer
Chemotherapeutic Toxicity
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Fasting Mimicking Diet (Xentigen by L'Nutra)
Description:
L-Nutra Xentigen is a product which will provide all the food to be consumed by subjects
during 3 days prior to chemotherapy and for 24 hours after chemotherapy. Xentigen is a
plant-based diet program designed to attain fasting-like effects while providing both
macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD
consists of 100% ingredients that are generally regarded as safe (GRAS) and comprises
proprietary vegetable-based soups and broths, energy bars, energy drinks, cracker snacks,
herbal teas, and supplements. The FMD consists of a 4-day regimen that provides
approximately 1100 kilocalories for the first day and approximately 500 kilocalories per
day for the second to the fourth day. Subsequently, a day 5 of transition diet
(approximately 800 kilocalories) is provided to avoid the refeeding syndrome.
Arm group label:
Carboplatin and paclitaxel with fasting mimicking diet (FMD)
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Given IV
Arm group label:
Carboplatin and paclitaxel with fasting mimicking diet (FMD)
Arm group label:
Carboplatin and paclitaxel with standard diet
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Given IV
Arm group label:
Carboplatin and paclitaxel with fasting mimicking diet (FMD)
Arm group label:
Carboplatin and paclitaxel with standard diet
Intervention type:
Dietary Supplement
Intervention name:
Standard diet
Description:
Normal diet
Arm group label:
Carboplatin and paclitaxel with standard diet
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.
Criteria for eligibility:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NorthShore University HealthSystem
Address:
City:
Evanston
Zip:
60201
Country:
United States
Contact:
Last name:
Michele Britto, RN
Phone:
847-570-2109
Email:
mbritto@northshore.org
Investigator:
Last name:
Mary T Jenkins Vogel, MD
Email:
Principal Investigator
Start date:
May 25, 2024
Completion date:
June 1, 2031
Lead sponsor:
Agency:
NorthShore University HealthSystem
Agency class:
Other
Collaborator:
Agency:
L-Nutra Inc
Agency class:
Industry
Source:
NorthShore University HealthSystem
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921149
