Suppletie van proteïne, leucine en vitamine D bij patiënten met gynaecologische kanker die op platina gebaseerde chemotherapie krijgen (PRODIGY-1)
Suppletie van proteïne, leucine en vitamine D bij patiënten met gynaecologische kanker die eerstelijns chemotherapie op basis van platina krijgen
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Riccardo Caccialanza, MD
- Telefoonnummer: +390382501615
- E-mail: r.caccialanza@smatteo.pv.it
Studie Contact Back-up
- Naam: Emanuele Cereda, MD, PhD
- Telefoonnummer: +390382501615
- E-mail: e.cereda@smatteo.pv.it
Studie Locaties
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Italy
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Pavia, Italy, Italië, 27100
- Werving
- IRCCS San Matteo
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Hoofdonderzoeker:
- Emanuele Cereda, MD, PhD
-
Contact:
- Emanuele Cereda, MD, PhD
- Telefoonnummer: +390382501615
- E-mail: e.cereda@smatteo.pv.it
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Muscle-targeted nutritional support
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. |
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.
Andere namen:
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Ander: Standard of care
Control group receiving no nutritional intervention or on-demand non muscle-targeted nutritional intervention such as nutritional counseling with or without oral nutritional supplement |
Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in muscle mass area
Tijdsspanne: 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 |
18 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Skeletal muscle mass
Tijdsspanne: 18 weeks
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis |
18 weeks
|
|
Body weight
Tijdsspanne: 18 weeks
|
Change in body weight during the study (assessed at each chemotherapy cycle) |
18 weeks
|
|
Protein-calorie intake
Tijdsspanne: 18 weeks
|
Change in protein-calorie intake during the study (assessed at each chemotherapy cycle) |
18 weeks
|
|
Handgrip strength
Tijdsspanne: 18 weeks
|
Change in handgrip strength |
18 weeks
|
|
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
Tijdsspanne: 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. |
18 weeks
|
|
Adherence to treatment schedule
Tijdsspanne: 18 weeks
|
Difference in the proportion of patients completing the treatment schedule as planned |
18 weeks
|
|
Total dose of chemotherapy administered
Tijdsspanne: 18 weeks
|
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan |
18 weeks
|
|
Patients requiring unplanned hospitalization
Tijdsspanne: 18 weeks
|
The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated |
18 weeks
|
|
Tolerance to nutritional support
Tijdsspanne: 18 weeks
|
Occurrence of events of gastrointestinal intolerance |
18 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Emanuele Cereda, MD, PhD, Fondazione IRCCS Policlinico San Matteo
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0014137/23
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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