PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental product - Fortifit® Powder, Standard of care.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving First-line Platinum-based Chemotherapy
Overview
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.
Interventions
- 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
Primary outcome measures
- Change in muscle mass area [Time frame: 18 weeks]
Secondary outcome measures (9)
- Skeletal muscle mass [Time frame: 18 weeks]
- Body weight [Time frame: 18 weeks]
- Protein-calorie intake [Time frame: 18 weeks]
- Handgrip strength [Time frame: 18 weeks]
- Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0] [Time frame: 18 weeks]
- Adherence to treatment schedule [Time frame: 18 weeks]
- Total dose of chemotherapy administered [Time frame: 18 weeks]
- Patients requiring unplanned hospitalization [Time frame: 18 weeks]
- Tolerance to nutritional support [Time frame: 18 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS San Matteo — Pavia
Identifiers
NCT: NCT06087783 · 0014137/23