Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2025-07-29

Brief Summary

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This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on obesity-associated chronic inflammation.

SECONDARY OBJECTIVES:

I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.

TERTIARY OBJECTIVES:

I. To determine the effects of a 4-month CARE intervention on breast cancer prognosis and assess whether reductions in chronic inflammation are associated with breast cancer prognosis.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.

GROUP II: Patients undergo supervised traditional aerobic and resistance exercise (TARE) program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.

GROUP III: Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional digital video disc (DVD) and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.

After completion of study, patients are followed up at week 34, 8 and 12 months, and then every year for 8 years.

Conditions

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Cancer Survivor Central Obesity Estrogen Receptor Positive Postmenopausal Progesterone Receptor Positive Stage I Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Intervention Type OTHER

Ancillary studies

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Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal (at time of diagnosis; including artificial menopause induced by previous hysterectomy) women newly diagnosed (stage I-III) breast cancer low grade disease positive for estrogen and progesterone receptors
* Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) \> 30 kg/m\^2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat \> 30% (estimated by bioelectrical impedance), and waist circumference \> 35 inches (in)
* Have undergone a lumpectomy or mastectomy
* Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months
* Speak English or Spanish
* Is in breast cancer remission with no detectable disease present
* Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
* Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
* Have not experienced a weight reduction \>= 10% within past 6 months
* Currently participate in less than 60 minutes of structured exercise/week
* No planned reconstructive surgery with flap repair during trial and follow-up period
* May use adjuvant endocrine therapy if use will be continued for duration of study intervention
* Does not smoke (no smoking during previous 12 months)
* Willing to travel to the exercise facility at University of Southern California (USC)

Exclusion Criteria

* Patients with metastatic disease
* Is not centrally obese
* Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
* History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
* Participates in more than 60 minutes of structured exercise/week
* Is planning reconstructive surgery with flap repair during trial and follow-up period
* Currently smokes
* Is unable to travel to the exercise facility at USC

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No