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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Gynecologic Cancer

Treatments: Other: Standard of care; Dietary Supplement: Experimental product - Fortifit® Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT06087783

0014137/23

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Muscle-targeted nutritional support

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Experimental product - Fortifit® Powder

Standard of care

Other group

Description:

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

Treatment:

Other: Standard of care