Gynecologic Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTExperimental 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.
OTHERStandard 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
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single-group intervention study compared to matched historical controls
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Tolerance to nutritional support | 18 weeks | Occurrence of events of gastrointestinal intolerance |
| 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 |
| 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. |
Countries
Italy
Contacts
Primary ContactEmanuele Cereda, MD, PhD
Backup ContactRiccardo Caccialanza, MD
Outcome results
None listed