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

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.

Eligibility

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

Conditions2

Browse More Trials