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Survival TRaining for ENhancing Total Health (STRENGTH)

15. december 2017 opdateret af: Duke University

A Phase II Randomized Study to Assess the Feasibility of Distance Medicine Based Exercise and Dietary Approaches to Prevent Body Composition Change Occurring During Adjuvant Chemotherapy for Early Stage Breast Cancer

RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue.

PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the efficacy of exercise alone or combined with a modified diet as home-based interventions to prevent increases in body fat during adjuvant chemotherapy in women with stage I, II, or IIIA breast cancer.
  • Compare the efficacy of these regimens, in terms of reducing gains in adipose tissue, reducing losses in absolute amounts of lean body tissue, reducing gains in weight, influencing levels of biomarkers associated with the risk of breast cancer and/or other comorbid conditions, improving self-efficacy for exercise behaviors, reducing depression, and improving quality of life in these patients.
  • Compare the adherence rates to these regimens in these patients.
  • Determine the associations between study condition and adherence and change in endpoints in patients treated with these regimens.
  • Determine the feasibility of conducting home-based exercise and diet studies using the infrastructure of the cooperative group.

OUTLINE: This is a pilot, randomized, multicenter study. Patients are stratified according to body mass index (no more than 25 kg/m^2 vs more than 25 kg/m^2), race (white vs non-white), and prior exercise history (vigorous exercise of at least 30 minutes, 3 times a week prior to diagnosis) (yes vs no). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (calcium-rich diet): Patients receive materials and counseling to promote a diet that contains ample amounts of calcium (1,200-2,500 mg/day).
  • Arm II (calcium-rich diet and exercise): Patients receive materials and counseling as in arm I and instruction and materials to promote strength training and endurance exercises.
  • Arm III (calcium-rich, high fruit and vegetable, low-fat diet and exercise): Patients receive materials and counseling as in arm II and materials and counseling to consume at least 5 servings of vegetables and fruit per day and limit fat intake to less than 20% of total calories.

In all arms, patients continue regimens for 6 months.

Measurements of body composition, weight, waist circumference, serum levels of insulin, insulin-like growth factor, sex hormone-binding globulin, and total cholesterol are obtained at baseline and 6 months.

Quality of life, depression, diet composition, and physical activity are assessed at baseline and at 3 and 6 months.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study within 16 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Southeastern Medical Oncology Center
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1030
        • Comprehensive Cancer Center at Wake Forest University
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Cancer Centers of the Carolinas - Eastside

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Stage I, II, or IIIA
  • Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal Status

  • Premenopausal, defined as at least 1 of the following:

    • Less than 4 months since last menstrual period at diagnosis
    • Follicle-stimulating hormone level in the premenopausal range

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • No calcium-based kidney stones

Cardiovascular

  • No angina within the past 6 months
  • No myocardial infarction within the past 6 months
  • No abnormal MUGA and/or stress test

Other

  • Not pregnant or nursing
  • Access to a telephone
  • Able to read and speak English
  • No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No history of hyperthyroidism or hypothyroidism
  • No paralysis
  • No osteoarthritis with uncontrolled joint pain that would preclude exercise
  • No diverticulitis
  • No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires
  • No medical condition that would interfere with body composition assessment
  • No medical condition for which unsupervised exercise is contraindicated
  • No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • No prior bilateral oophorectomy
  • No prior amputation
  • No concurrent transverse rectus abdominis myocutaneous surgery
  • No concurrent surgery

Other

  • No concurrent blood-thinners (e.g., coumadin or warfarin)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 1: calcium diet
Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).
Kosttilskud: Calcium-Rich Diet
1,200 - 2,500 mg/day. 6 month intervention
Andre navne:
  • Kalk
Aktiv komparator: Arm 2: Exercise + Calcium-Rich Diet
Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day).
Andet: Arm 2: Exercise + Calcium-Rich Diet
Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.
Andre navne:
  • Kalk
Aktiv komparator: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
Dietary counseling + materials promoting strength training and aerobic activity + a diet that has < 20% of energy coming from fat and intakes of fruits and vegetables of > 5 servings/day + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.
Andet: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
1,200 - 2,500 Calcium intake per day. 6 month intervention period.
Andre navne:
  • Kalk

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting
Tidsramme: 6 months
Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Duke University

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Edward G. Shaw, MD, Wake Forest University Health Sciences
  • Ledende efterforsker: Wendy Demark-Wahnefried, PhD, Duke Cancer Institute
  • Studiestol: Roger T. Anderson, PhD, Wake Forest University Health Sciences

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

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. september 2003

Primær færdiggørelse (Faktiske)

1. januar 2004

Studieafslutning (Faktiske)

1. januar 2005

Datoer for studieregistrering

Først indsendt

10. september 2003

Først indsendt, der opfyldte QC-kriterier

10. september 2003

Først opslået (Skøn)

11. september 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2017

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U10CA081851 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Depression

Kliniske forsøg med Calcium-Rich Diet

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner