PROtein, leucin og vitamin D-tilskudd hos pasienter med gynekologisk kreft som får platinabasert kjemoterapi (PRODIGY-1)
PROtein, leucin og vitamin D-tilskudd hos pasienter med gynekologisk kreft som får førstelinjeplatinabasert kjemoterapi
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Riccardo Caccialanza, MD
- Telefonnummer: +390382501615
- E-post: r.caccialanza@smatteo.pv.it
Studer Kontakt Backup
- Navn: Emanuele Cereda, MD, PhD
- Telefonnummer: +390382501615
- E-post: e.cereda@smatteo.pv.it
Studiesteder
-
-
Italy
-
Pavia, Italy, Italia, 27100
- Rekruttering
- IRCCS San Matteo
-
Hovedetterforsker:
- Emanuele Cereda, MD, PhD
-
Ta kontakt med:
- Emanuele Cereda, MD, PhD
- Telefonnummer: +390382501615
- E-post: e.cereda@smatteo.pv.it
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
|
Annen: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in muscle mass area
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skeletal muscle mass
Tidsramme: 18 weeks
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis |
18 weeks
|
|
Body weight
Tidsramme: 18 weeks
|
Change in body weight during the study (assessed at each chemotherapy cycle) |
18 weeks
|
|
Protein-calorie intake
Tidsramme: 18 weeks
|
Change in protein-calorie intake during the study (assessed at each chemotherapy cycle) |
18 weeks
|
|
Handgrip strength
Tidsramme: 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]
Tidsramme: 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
Tidsramme: 18 weeks
|
Difference in the proportion of patients completing the treatment schedule as planned |
18 weeks
|
|
Total dose of chemotherapy administered
Tidsramme: 18 weeks
|
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan |
18 weeks
|
|
Patients requiring unplanned hospitalization
Tidsramme: 18 weeks
|
The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated |
18 weeks
|
|
Tolerance to nutritional support
Tidsramme: 18 weeks
|
Occurrence of events of gastrointestinal intolerance |
18 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Emanuele Cereda, MD, PhD, Fondazione IRCCS Policlinico San Matteo
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0014137/23
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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