NCT05921149Not yet recruiting
Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
A Randomized Controlled Study of a Fasting Mimicking Diet (FMD) in Conjunction With Combination Carboplatin and Paclitaxel in the Treatment of Patients With Advanced or Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Source: ClinicalTrials.gov · Last updated 7 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 23 Apr 2023
- Start date
- 25 May 2024
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Endeavor Health
- Diseases
- Ovarian cancer
- NCT number
- NCT05921149
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 25 May 2024 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- 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)
Other
- Patients with malnutrition and/ or BMI \<19
Who the study is looking for
- 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).
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NorthShore University HealthSystem Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.