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

RecruitingNAAges 18 Years - anyFemaleFondazione IRCCS Policlinico San Matteo di Pavia
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In plain words

What the trial is, and whether it could suit you

Open clinical trial addressing the effect of a nutritional support based on whey proteins, leucine and vitamin D on muscle mass and multiple anticancer treatment-related endpoints in patients with gynecologic cancer receiving first-line platinum-based chemotherapy (adjuvant or curative). A comparison to matched historical controls will be performed to address potential evidence of efficacy to be investigated in a subsequent randomized trial.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Experimental product - Fortifit® Powder
  • Standard of care
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Where

1 site
IRCCS San Matteo
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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