Reducing Breast Cancer Recurrence With Weight Loss (ENERGY)
17. juni 2015 opdateret af: Cheryl Rock, University of California, San Diego
Reducing Breast Cancer Recurrence With Weight Loss: A Vanguard Trial
The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue.
Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated.
Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
692
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294-3360
- University of Alabama at Birmingham
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California
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La Jolla, California, Forenede Stater, 92093
- Moores UCSD Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Denver
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Missouri
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St. Louis, Missouri, Forenede Stater, 63110
- Washington University in St. Louis:
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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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
- BMI between 25 to 45 kg/m2
- Able to comply with all required study procedures and schedule
Exclusion Criteria:
- Serious medical condition or psychiatric illness
- Inability to be moderately physically active
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
- Currently enrolled in a weight loss program
- Current use of weight loss medication or supplements
- Previous surgical procedures for weight reduction
- Planning weight loss surgery in the next 2 years.
- 6+ months use of meds likely to cause weight gain or prevent weight loss
- Planned surgical procedure that can impact the conduct of the study
- Currently pregnant/breastfeeding
- Planning to become pregnant within the next 2 years
- Have plans to relocate from area within 2 years
- Family relative or close friend is a trial staff member or a study participant
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Less Intensive Group
Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.
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Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.
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Eksperimentel: Intensive Group
Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
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Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Vægttab
Tidsramme: 2 år
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2 år
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Improvement in quality of life
Tidsramme: 2 years
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2 years
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Improvement in fatigue
Tidsramme: 2 years
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2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cheryl L. Rock, PhD, RD, University of California, San Diego
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kenzik KM, Demark-Wahnefried W, Ganz PA, Colditz G, Rock CL, Rogers LQ. Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors. Ann Behav Med. 2018 Nov 12;52(12):999-1009. doi: 10.1093/abm/kay004.
- Rock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H. Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. J Clin Oncol. 2015 Oct 1;33(28):3169-76. doi: 10.1200/JCO.2015.61.1095. Epub 2015 Aug 17.
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
1. maj 2010
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
26. april 2010
Først indsendt, der opfyldte QC-kriterier
27. april 2010
Først opslået (Skøn)
28. april 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CA148791-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .