To hear about similar clinical trials, please enter your email below
Trial Title:
PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
NCT ID:
NCT06087783
Condition:
Gynecologic Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Single-group intervention study compared to matched historical controls
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Experimental product - Fortifit® Powder
Description:
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.
Arm group label:
Muscle-targeted nutritional support
Other name:
Muscle-targeted nutritional support
Intervention type:
Other
Intervention name:
Standard of care
Description:
Control group receiving no nutritional intervention or on-demand non muscle-targeted
intervention such as nutritional counseling with or without oral nutritional supplement
Arm group label:
Standard of care
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Disease setting is gender-specific
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Fondazione IRCCS Policlinico San Matteo di Pavia
Agency class:
Other
Source:
Fondazione IRCCS Policlinico San Matteo di Pavia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087783
