PRODIGY-1: PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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:
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| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- Skeletal muscle mass [18 weeks]
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis
- 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
- 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.
- Adherence to treatment schedule [18 weeks]
Difference in the proportion of patients completing the treatment schedule as planned
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine, cervical);
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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;
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Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
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signed informed consent.
Exclusion Criteria:
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age <18 years
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ECOG performance status >2
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indication to or ongoing artificial nutrition support
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known kidney failure (previous glomerular filtration rate <30 ml/min);
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known liver failure (Child B or C)
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endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
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decompensated diabetes
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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.
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known allergy to milk, milk products or other components of the proposed interventions
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inclusion in other nutritional intervention trials
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patients refusal
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- IRCCS Policlinico S. Matteo
Investigators
- Principal Investigator: Emanuele Cereda, MD, PhD, Fondazione IRCCS Policlinico San Matteo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0014137/23