Nutritional support for gynecologic cancer patients undergoing chemotherapy
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving First-line Platinum-based Chemotherapy
This study tests if adding a special nutritional supplement to the standard care can help women with gynecologic cancer undergoing chemotherapy maintain muscle mass and improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Italy) |
| Trial ID | NCT06087783 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of nutritional supplementation with whey proteins, leucine, and vitamin D on muscle mass and various treatment-related outcomes in patients with gynecologic cancer receiving platinum-based chemotherapy. The study will compare results to matched historical controls to assess potential efficacy, which may lead to a subsequent randomized trial. Participants will receive the experimental product Fortifit® Powder alongside standard care during their treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed diagnosis of gynecologic cancer who are about to start first-line platinum-based chemotherapy.
Not a fit: Patients under 18 years old or those with severe performance status or specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve muscle mass and overall treatment outcomes for patients undergoing chemotherapy for gynecologic cancer.
How similar studies have performed: While this approach is novel in this specific context, similar nutritional interventions have shown promise in other cancer treatment settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine, cervical); * indication for a first-line chemotherapy (adjuvant or curative) with a platinum-based regimen to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines; * Eastern Cooperative Oncology Group (ECOG) performance status ≤2; * signed informed consent. Exclusion Criteria: * age \<18 years * ECOG performance status \>2 * indication to or ongoing artificial nutrition support * known kidney failure (previous glomerular filtration rate \<30 ml/min); * known liver failure (Child B or C) * endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis) * decompensated diabetes * indications related to the study product: more than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources; adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study. * known allergy to milk, milk products or other components of the proposed interventions * inclusion in other nutritional intervention trials * patients refusal
Where this trial is running
Pavia, Italy
- IRCCS San Matteo — Pavia, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Emanuele Cereda, MD, PhD — Fondazione IRCCS Policlinico San Matteo
- Study coordinator: Emanuele Cereda, MD, PhD
- Email: e.cereda@smatteo.pv.it
- Phone: +390382501615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.