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

Last updated: April 29, 2025
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Pelvic Cancer

Treatment

Experimental product - Fortifit® Powder

Standard of care

Clinical Study ID

NCT06087783
0014137/23
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine,cervical);

  • indication for a first-line chemotherapy (adjuvant or curative) with aplatinum-based regimen to be used by investigator's choice within the framework ofgood clinical practice and in agreement with current Italian Association of MedicalOncology guidelines;

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2;

  • signed informed consent.

Exclusion

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 (excludingosteoporosis)

  • decompensated diabetes

  • indications related to the study product: more than 10 µg (400 IU) of daily VitaminD intake from medical sources More than 500 mg of daily calcium intake from medicalsources; adherence to a high energy or high protein diet up or use of proteincontaining or amino acid containing nutritional supplements up to three monthsbefore starting the study.

  • known allergy to milk, milk products or other components of the proposedinterventions

  • inclusion in other nutritional intervention trials

  • patients refusal

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Experimental product - Fortifit® Powder
Phase:
Study Start date:
July 08, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • IRCCS San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

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