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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscle-targeted nutritional support | Experimental | 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. |
|
| Standard of care | Other | Control group receiving no nutritional intervention or on-demand non muscle-targeted nutritional intervention such as nutritional counseling with or without oral nutritional supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental product - Fortifit® Powder | Dietary Supplement | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Disease setting is gender-specific
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Cereda, MD, PhD | Contact | +390382501615 | e.cereda@smatteo.pv.it | |
| Riccardo Caccialanza, MD | Contact | +390382501615 | r.caccialanza@smatteo.pv.it |
| Name | Affiliation | Role |
|---|---|---|
| Emanuele Cereda, MD, PhD | Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Matteo | Recruiting | Pavia | Italy | 27100 | Italy |
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Single-group intervention study compared to matched historical controls
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|
|
| Standard of care | Other | Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement |
|
| 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 |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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