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Survival TRaining for ENhancing Total Health (STRENGTH)

15 december 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

39

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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).
Kosttillskott: Calcium-Rich Diet
1,200 - 2,500 mg/day. 6 month intervention
Andra namn:
  • Kalcium
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).
Övrig: 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.
Andra namn:
  • Kalcium
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.
Övrig: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
1,200 - 2,500 Calcium intake per day. 6 month intervention period.
Andra namn:
  • Kalcium

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Samarbetspartners

National Cancer Institute (NCI)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2003

Primärt slutförande (Faktisk)

1 januari 2004

Avslutad studie (Faktisk)

1 januari 2005

Studieregistreringsdatum

Först inskickad

10 september 2003

Först inskickad som uppfyllde QC-kriterierna

10 september 2003

Första postat (Uppskatta)

11 september 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 december 2017

Senast verifierad

1 april 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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