NCT06087783 PROtein, Leucine and Vitamin D Supplementation In Patients With GYnecologic Cancer Receiving Platinum-based Chemotherapy
| NCT ID | NCT06087783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Gynecologic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-07-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Emanuele Cereda, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Policlinico San Matteo
Frequently Asked Questions
Who can join the NCT06087783 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06087783 currently recruiting?
Yes, NCT06087783 is actively recruiting participants. Contact the research team at e.cereda@smatteo.pv.it for enrollment information.
Where is the NCT06087783 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06087783 clinical trial?
NCT06087783 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The principal investigator is Emanuele Cereda, MD, PhD at Fondazione IRCCS Policlinico San Matteo. The trial plans to enroll 50 participants.
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