Clinical trial · Interventional
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
NCT00068458CI-TRIAL-00030832completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Depression | — | UNRESOLVED | — |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 2: Exercise + Calcium-Rich Diet | Other | — | UNRESOLVED |
| Calcium-Rich Diet | Dietary Supplement | — | UNRESOLVED |
| Exercise + Fruit & Vegetable, Low Fat + Calcium Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: calcium diet
- description
- Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).
- interventionNames
- Dietary Supplement: Calcium-Rich Diet
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Exercise + Calcium-Rich Diet
- description
- Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day).
- interventionNames
- Other: Arm 2: Exercise + Calcium-Rich Diet
- type
- ACTIVE_COMPARATOR
- label
- Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTDemark-Wahnefried W, Case LD, Blackwell K, Marcom PK, Kraus W, Aziz N, Snyder DC, Giguere JK, Shaw E. Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Clin Breast Cancer. 2008 Feb;8(1):70-9. doi: 10.3816/CBC.2008.n.005. PMID 18501061