Nutritional support for gynecologic cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.