PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Oct 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how nutritional support, specifically a mix of whey proteins, leucine, and vitamin D, can help women with gynecologic cancer who are receiving platinum-based chemotherapy. The goal is to see if this nutritional support can improve muscle mass and other important health outcomes related to cancer treatment. This study is not yet recruiting participants, but it will compare results from women in this trial to historical data from women who have received similar treatment in the past.

To be eligible for this trial, participants must be women aged 18 and older with a confirmed diagnosis of gynecologic cancer (such as ovarian, uterine, or cervical cancer) and who are set to start first-line chemotherapy. They should also be in decent health, with a performance status score of 2 or lower, which means they can carry out some daily activities. Participants will need to sign a consent form to join the study. It’s important to know that certain health conditions, such as serious kidney or liver problems, or allergies to milk products, may prevent someone from participating. If eligible, participants can expect to receive the nutritional support and contribute to valuable research that may help improve future treatments for others.

Gender

FEMALE

Eligibility 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