An interventional study of Experimental product - Fortifit® Powder and Standard of care in Gynecologic Cancer, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment
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.
Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Also known as: Muscle-targeted nutritional support
Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement
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
Time frame: 18 weeks
Skeletal muscle mass
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis
Time frame: 18 weeks
Body weight
Change in body weight during the study (assessed at each chemotherapy cycle)
Time frame: 18 weeks
Protein-calorie intake
Change in protein-calorie intake during the study (assessed at each chemotherapy cycle)
Time frame: 18 weeks
Handgrip strength
Change in handgrip strength
Time frame: 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.
Time frame: 18 weeks
Adherence to treatment schedule
Difference in the proportion of patients completing the treatment schedule as planned
Time frame: 18 weeks
Total dose of chemotherapy administered
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Time frame: 18 weeks
Patients requiring unplanned hospitalization
The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated
Time frame: 18 weeks
Tolerance to nutritional support
Occurrence of events of gastrointestinal intolerance
Time frame: 18 weeks
Plan to share: Undecided
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Fondazione IRCCS Policlinico San Matteo di Pavia