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

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer
• Interventions: Other: Standard of care; Dietary Supplement: Experimental product - Fortifit® Powder

• Registration Number: NCT06087783
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-14
• Study First Posted: 2023-10-18
• Study Start: 2024-07-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Control group receiving no nutritional intervention or on-demand non muscle-targeted nutritional intervention such as nutritional counseling with or without oral nutritional supplement
Muscle-targeted nutritional support	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.

Primary Outcome Measures

Name	Time	Method
Change in muscle mass area	18 weeks	Change in muscle mass at the end of first-line platinum-based chemotherapy (adjuvant or curative) evaluated with computed tomography scan at the level of the third lumbar vertebra

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle mass	18 weeks	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis
Adherence to treatment schedule	18 weeks	Difference in the proportion of patients completing the treatment schedule as planned
Body weight	18 weeks	Change in body weight during the study (assessed at each chemotherapy cycle)
Protein-calorie intake	18 weeks	Change in protein-calorie intake during the study (assessed at each chemotherapy cycle)
Handgrip strength	18 weeks	Change in handgrip strength
Total dose of chemotherapy administered	18 weeks	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Patients requiring unplanned hospitalization	18 weeks	The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated
Tolerance to nutritional support	18 weeks	Occurrence of events of gastrointestinal intolerance
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]	18 weeks	Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0. Toxicity is graded on 0-5 ordinal scale where a higher score means a worse outcome.

Trial Locations

Locations (1)

IRCCS San Matteo; 🇮🇹 Pavia, Italy