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

NCT06087783 | Recruiting DMC

• 1 other identifier: 0014137/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Skeletal muscle mass

  18 weeks

• Body weight

  18 weeks

• Protein-calorie intake

  18 weeks

• Handgrip strength

  18 weeks

• Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]

  18 weeks

Study Arms (2)

Muscle-targeted nutritional support

EXPERIMENTAL

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

Standard of care

OTHER

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

Interventions

Experimental product - Fortifit® Powder DIETARY_SUPPLEMENT

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.

Also known as: Muscle-targeted nutritional support

Muscle-targeted nutritional support

Standard of care OTHER

Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Disease setting is gender-specific
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• patients refusal

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

IRCCS San Matteo

Pavia, Italy, 27100, Italy

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emanuele Cereda, MD, PhD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuele Cereda, MD, PhD

CONTACT

+390382501615; e.cereda@smatteo.pv.it

Riccardo Caccialanza, MD

CONTACT

+390382501615; r.caccialanza@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-group intervention study compared to matched historical controls

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 18, 2023
• Study Start: July 8, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

IT (1)