Clinical trial NCT06087783: PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
Official title: PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving First-line Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-group intervention study compared to matched historical controls
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in muscle mass area
timeFrame: 18 weeks
Secondary outcomes:
measure: Skeletal muscle mass
timeFrame: 18 weeks
measure: Body weight
timeFrame: 18 weeks
measure: Protein-calorie intake
timeFrame: 18 weeks
measure: Handgrip strength
timeFrame: 18 weeks
measure: Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
timeFrame: 18 weeks
measure: Adherence to treatment schedule
timeFrame: 18 weeks
measure: Total dose of chemotherapy administered
timeFrame: 18 weeks
measure: Patients requiring unplanned hospitalization
timeFrame: 18 weeks
measure: Tolerance to nutritional support
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Emanuele Cereda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: