Status:
RECRUITING
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 gyn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06087783
Start Date
July 8 2024
End Date
November 30 2026
Last Update
May 1 2025
Active Locations (1)
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1
IRCCS San Matteo
Pavia, Italy, Italy, 27100