Actively Recruiting
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-05-01
50
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine, cervical)
- Planned first-line chemotherapy with a platinum-based regimen as chosen by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- Signed informed consent
You will not qualify if you...
- Age under 18 years
- ECOG performance status higher than 2
- Need for or ongoing artificial nutrition support
- Known kidney failure with glomerular filtration rate below 30 ml/min
- Known liver failure classified as Child B or C
- Endocrine disorders affecting calcium metabolism (except osteoporosis)
- Decompensated diabetes
- Taking more than 400 IU daily vitamin D from medical sources
- Taking more than 500 mg daily calcium from medical sources
- Following a high-energy or high-protein diet or using protein or amino acid supplements within 3 months before starting the study
- Known allergy to milk, milk products, or components of the study interventions
- Participation in other nutritional intervention trials
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS San Matteo
Pavia, Italy, Italy, 27100
Actively Recruiting
Research Team
E
Emanuele Cereda, MD, PhD
CONTACT
R
Riccardo Caccialanza, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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