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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

Phase 2
18 Years
Not Enrolling
Breast Cancer, Depression, Weight Changes

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Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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



- 18 and over


- 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


- Not specified


- Not specified


- No calcium-based kidney stones


- No angina within the past 6 months

- No myocardial infarction within the past 6 months

- No abnormal MUGA and/or stress test


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- No prior bilateral oophorectomy

- No prior amputation

- No concurrent transverse rectus abdominis myocutaneous surgery

- No concurrent surgery


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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting

Outcome Description:

Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Edward G. Shaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:

CCCWFU 97301



Start Date:

September 2003

Completion Date:

January 2005

Related Keywords:

  • Breast Cancer
  • Depression
  • Weight Changes
  • weight changes
  • depression
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Body Weight Changes
  • Breast Neoplasms
  • Depression
  • Depressive Disorder



Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Southeastern Medical Oncology Center Goldsboro, North Carolina  27534
Cancer Centers of the Carolinas - Eastside Greenville, South Carolina  29601