Trials / Recruiting
RecruitingNCT06087783
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving First-line Platinum-based Chemotherapy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Experimental product - Fortifit® Powder | Two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
| OTHER | Standard of care | Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement |
Timeline
- Start date
- 2024-07-08
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
- First posted
- 2023-10-18
- Last updated
- 2025-05-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06087783. Inclusion in this directory is not an endorsement.