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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Dietary Supplement: Experimental product - Fortifit® Powder
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-group intervention study compared to matched historical controls
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle-targeted nutritional support<br>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<br>* 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.<br>* Other names: Muscle-targeted nutritional support;|
| Other: Standard of care<br>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<br>* Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement<br>|

What is the study measuring?
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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 |