Survival TRaining for ENhancing Total Health (STRENGTH)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke Comprehensive Cancer Center
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Goldsboro、North Carolina、アメリカ、27534
- Southeastern Medical Oncology Center
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Winston-Salem、North Carolina、アメリカ、27157-1030
- Comprehensive Cancer Center at Wake Forest University
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South Carolina
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Greenville、South Carolina、アメリカ、29615
- Cancer Centers of the Carolinas - Eastside
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm 1: calcium diet
Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).
|
1,200 - 2,500 mg/day.
6 month intervention
他の名前：
|
|
アクティブコンパレータ：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).
|
Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day.
6 month intervention.
他の名前：
|
|
アクティブコンパレータ：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.
|
1,200 - 2,500 Calcium intake per day.
6 month intervention period.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Edward G. Shaw, MD、Wake Forest University Health Sciences
- 主任研究者：Wendy Demark-Wahnefried, PhD、Duke Cancer Institute
- スタディチェア：Roger T. Anderson, PhD、Wake Forest University Health Sciences
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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