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NCT Number: NCT06087783

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

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Matteo

Pavia, Italy, 27100

Location status: Recruiting

Location contact

Emanuele Cereda, MD, PhD

CONTACT

[email protected]

+390382501615

Emanuele Cereda, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental product - Fortifit® Powder

Dietary Supplement

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.

Other names: Muscle-targeted nutritional support

Standard of care

Other

Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement

Primary outcomes

  1. Change in muscle mass area

    Time frame: 18 weeks

    Change in muscle mass at the end of first-line platinum-based chemotherapy (adjuvant or curative) evaluated with computed tomography scan at the level of the third lumbar vertebra

Secondary outcomes

  1. Skeletal muscle mass

    Time frame: 18 weeks

    Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis

  2. Body weight

    Time frame: 18 weeks

    Change in body weight during the study (assessed at each chemotherapy cycle)

  3. Protein-calorie intake

    Time frame: 18 weeks

    Change in protein-calorie intake during the study (assessed at each chemotherapy cycle)

  4. Handgrip strength

    Time frame: 18 weeks

    Change in handgrip strength

  5. Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]

    Time frame: 18 weeks

    Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0. Toxicity is graded on 0-5 ordinal scale where a higher score means a worse outcome.

  6. Adherence to treatment schedule

    Time frame: 18 weeks

    Difference in the proportion of patients completing the treatment schedule as planned

  7. Total dose of chemotherapy administered

    Time frame: 18 weeks

    To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan

  8. Patients requiring unplanned hospitalization

    Time frame: 18 weeks

    The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated

  9. Tolerance to nutritional support

    Time frame: 18 weeks

    Occurrence of events of gastrointestinal intolerance

Study contacts

Contact information is provided by the study sponsor or research team.

Emanuele Cereda, MD, PhD

CONTACT

[email protected]

+390382501615

Riccardo Caccialanza, MD

CONTACT

[email protected]

+390382501615

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Acronym: PRODIGY-1

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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