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

Gynecologic Cancer Clinical Trial

— PRODIGY-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06087783
• Other study ID #: 0014137/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: October 2023
• Source: IRCCS Policlinico S. Matteo
• Contact: Emanuele Cereda, MD, PhD
• Phone: +390382501615
• Email: e.cereda[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Skeletal muscle mass	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis	18 weeks
Secondary	Body weight	Change in body weight during the study (assessed at each chemotherapy cycle)	18 weeks
Secondary	Protein-calorie intake	Change in protein-calorie intake during the study (assessed at each chemotherapy cycle)	18 weeks
Secondary	Handgrip strength	Change in handgrip strength	18 weeks
Secondary	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
Secondary	Adherence to treatment schedule	Difference in the proportion of patients completing the treatment schedule as planned	18 weeks
Secondary	Total dose of chemotherapy administered	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan	18 weeks
Secondary	Patients requiring unplanned hospitalization	The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated	18 weeks
Secondary	Tolerance to nutritional support	Occurrence of events of gastrointestinal intolerance	18 weeks