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Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance

18. august 2026 oppdatert av: Roswell Park Cancer Institute

Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance

This clinical trial compares two different weight-loss programs, daily continuous calorie energy reduction (CER) versus (vs.) 5:2 intermittent fasting (IF), in preventing progression of kidney (renal) cancer among patients with one or more small renal masses (SRM) undergoing active surveillance (AS). Kidney cancer patients tend to have changes in metabolism that may increase body weight, but weight-loss strategies that work for best for these patients are unknown. The CER program requires a set daily limit for calories. The IF program requires fasting for 2 days a week and normal eating for the remaining 5 days. Both will include self-monitoring with interventionist feedback. This trial may help researchers determine whether the IF program works better than the CER program in improving weight loss, physical health, and/or reducing the risk of kidney cancer progression among patients with small renal masses undergoing AS

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. Adapt two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in SRM patients on AS.

II. Determine the feasibility of the two intervention programs (IF and CER).

SECONDARY OBJECTIVE:

I. Measure, compare and explore preliminary effect sizes of IF vs. CER on body weight, diet, body composition, tumor growth, and rates of clinical progression and invasive treatment conversion

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Rekruttering
        • Roswell Park Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eric Kauffmann, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • English speaking
  • SRM patient with biopsy-confirmed RCC who are initiating or already on AS
  • Age 18 years or older
  • Body mass index (BMI) ≥ 25 kg/m^2
  • No medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
  • No weight loss medication in the past 3 months
  • Not pregnant or lactating
  • No more than 5% body weight loss in the past 3 months
  • No bariatric surgery in the last 10 years

Exclusion Criteria:

  • Non-English speaking
  • Less than 18 years old
  • BMI < 25 kg/m^2
  • Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
  • On weight loss medication in the past 3 months
  • Pregnant or lactating
  • More than 5% body weight loss in the past 3 months
  • Bariatric surgery in the last 10 years
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
  • Unwilling or unable to follow protocol requirements
  • Received an investigational agent within 30 days prior to enrollment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I - CER Program
Patients complete the CER program for 6 months. The CER intervention will be adapted to renal cell carcinoma patients on active surveillance
Annen: Continuous Energy Restriction (CER)
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Aktiv komparator: Arm II - IF Program
Patients will complete the IF program for 6 months. The IF arm will mirror the CER arm with the exception that IF additionally include 2 fasting days per week during which participants will be instructed to eat one 500-600kcal meal per fasting day.
Annen: Intermittent Fasting
The IF intervention will instruct participants how to fast safely, how to conduct a 5:2 fast, and encourage moderate physical activity. Self-monitoring with interventionist feedback will also be included

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participation Rate
Tidsramme: At 6 months
This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant
At 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in tumor size
Tidsramme: At baseline and at 6 months
Will be assessed based on radiologic imaging. Within-group differences between baseline and 6 months will be examined using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar's test for categorical variables.
At baseline and at 6 months
Rate of clinical progression
Tidsramme: Up to 6 months
defined based on radiologic tumor size (> 4 cm), stage (> cT1a) and growth rate (> 5 mm/year for < 3 cm size; > 3 mm/year for tumor size > 3 cm), in addition to biopsy histology (high grade or unclassified renal cell carcinoma histologic subtype) and patient symptomology (bleeding or paraneoplastic symptoms/signs attributable to the tumor), as per the International Consultation for Urologic Disease guidelines
Up to 6 months
Change in Body composition
Tidsramme: Baseline and at 6 months
Will be measured using a body composition monitor, which uses bioelectrical impedance analysis to measure whole body and segmental body composition, including trunk fat..
Baseline and at 6 months
Change in Dietary Intake
Tidsramme: Baseline and 6 months
Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.
Baseline and 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Roswell Park Cancer Institute

Etterforskere

  • Hovedetterforsker: Eric Kaufmann, Roswell Park Comprehensive Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • I-4928826

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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