Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pancreas ernæringsprogram for vægttab hos overvægtige/fede patienter med stadium I-III brystkræft

28. september 2026 opdateret af: City of Hope Medical Center

BUDSKREATISK NÆRINGSPROGRAM (PNP): Et nyt vægtreduktionsprogram hos overvægtige/fede brystkræftoverlevere

This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To estimate the change in body weight at 6 months post-intervention relative to baseline.

SECONDARY OBJECTIVES:

I. To examine changes in: body composition; body chemistry; physical fitness; inflammatory markers; deoxyribonucleic acid (DNA) repair capacity; and quality of life per the Functional Assessment of Cancer Therapy - Breast (FACT-B)+4, version 4 questionnaire at 6 months post-intervention relative to baseline.

II. To describe adverse events possibly related to wearing the glucometer sensor or following the pancreatic nutritional program (PNP) diet.

III. To document compliance with the various components of the PNP (wearing the glucometer sensor; recording body weight; completing journal entries; completing meal cards; attending weekly counseling sessions with diet instructor).

OUTLINE:

Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks.

After completion of study, patients are followed up within 1 week and then at 6 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Patients with early-stage breast cancer (stage I-III)
  • Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment
  • Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
  • Body mass index (BMI) of 25-33 kg/m^2
  • Patients must be willing to adhere to the PNP intervention and the entire 6-month study
  • All patients must have the ability and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients who are diabetic
  • Patients whose BMI falls outside the eligible range (< 25 kg/m^2 or > 33 kg/m^2)
  • Patients with stage IV breast cancer
  • Patients with Rheumatoid Arthritis and other inflammatory diseases that would impact correlative studies

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supportive care (PNP)

Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks.
Andet: Laboratory Biomarker Analysis

Correlative studies

Andet: Quality-of-Life Assessment

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Kosttilskud: Dietary Intervention

Participate in the PNP

Andre navne:
  • Kostændringer
  • intervention, diæt
  • Ernæringsintervention
  • Ernæringsinterventioner
  • Ernæringsmæssige interventioner
Andet: Educational Intervention

Participate in the PNP

Andre navne:
  • Uddannelse til intervention
  • Intervention, pædagogisk

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body weight
Tidsramme: Baseline to 6 months

Tested using the paired t-test, alpha = 0.05.
Baseline to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i livskvalitetsscore (FACT-B+4)
Tidsramme: Baseline til 6 måneder
Baseline til 6 måneder
Overholdelsesmålinger (dage glukometersensor ikke brugt; dage med kropsvægt ikke registreret; dage med journalposteringer, dage der ikke er oprettet måltidskort; ugentlige rådgivningssessioner savnet)
Tidsramme: 12 uger
12 uger
Forekomst af uønskede hændelser rapporteret som muligvis eller definitivt relateret til at bære glukometersensoren efter PNP-diæten
Tidsramme: Op til 6 måneder
Op til 6 måneder
Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance)
Tidsramme: Baseline to up to 6 months

Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.
Baseline to up to 6 months
Change in body composition (BMI)
Tidsramme: Baseline to up to 6 months

Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.
Baseline to up to 6 months
Change in physical fitness (measured using a handgrip dynamometer)
Tidsramme: Baseline to 6 months

Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.
Baseline to 6 months
Change in serum inflammatory markers (C-reactive protein; cytokines)
Tidsramme: Baseline to 6 months

Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.
Baseline to 6 months
DNA repair capacity (comet assay's mean olive tail moment; number of gamma-H2A histone family, member X foci)
Tidsramme: Baseline to 6 months

Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing.
Baseline to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

City of Hope Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Joanne Mortimer, City of Hope Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. marts 2016

Primær færdiggørelse (Faktiske)

15. januar 2018

Studieafslutning (Faktiske)

19. december 2022

Datoer for studieregistrering

Først indsendt

29. april 2015

Først indsendt, der opfyldte QC-kriterier

29. april 2015

Først opslået (Anslået)

4. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14253
  • 14253 (Anden identifikator: City of Hope Medical Center)
  • NCI-2015-00654 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner