PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy (PRODIGY-1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Dietary supplement: Experimental product - Fortifit® Powder; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riccardo Caccialanza, MD; Phone Number: +390382501615; Email: r.caccialanza@smatteo.pv.it
• Study Contact Backup: Name: Emanuele Cereda, MD, PhD; Phone Number: +390382501615; Email: e.cereda@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • IRCCS San Matteo
    • Principal Investigator: Emanuele Cereda, MD, PhD
    • Contact: Emanuele Cereda, MD, PhD; Phone Number: +390382501615; Email: e.cereda@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle-targeted nutritional support; 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.	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 Names: Muscle-targeted nutritional support
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle mass area	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	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle mass	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis	18 weeks
Body weight	Change in body weight during the study (assessed at each chemotherapy cycle)	18 weeks
Protein-calorie intake	Change in protein-calorie intake during the study (assessed at each chemotherapy cycle)	18 weeks
Handgrip strength	Change in handgrip strength	18 weeks
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]	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.	18 weeks
Adherence to treatment schedule	Difference in the proportion of patients completing the treatment schedule as planned	18 weeks
Total dose of chemotherapy administered	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan	18 weeks
Patients requiring unplanned hospitalization	The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated	18 weeks
Tolerance to nutritional support	Occurrence of events of gastrointestinal intolerance	18 weeks

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Emanuele Cereda, MD, PhD, Fondazione IRCCS Policlinico San Matteo

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: October 14, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0014137/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No