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New treatment option for Gynecologic Cancer
Official title PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
ClinicalTrials.gov ID: NCT06087783
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- signed informed consent.
You likely can't join if
- 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)
See the full eligibility 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...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- signed informed consent.
- 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...
- known allergy to milk, milk products or other components of the proposed interventions
- inclusion in other nutritional intervention trials
- patients refusal
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Italy, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.