Physical Activity, Fatigue, Sleep, and Inflammation (ABLE)

The University of Alabama at Birmingham

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: 3 month physical activity intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01147367

ROG-SCCI-10-004-1

R21CA135017-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.

Full description

Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention.

Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels.

Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands.

This randomized controlled trial includes the following study aims:

Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention.

Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.

Enrollment

49 patients

Sex

Female

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female, 30 to 70 years of age, with first diagnosis of ductal carcinoma in situ (DCIS) or Stage I or Stage II breast cancer
If chemotherapy or radiation therapy was received, the patient must be at least 4 weeks status post final primary treatment administration to allow treatment related cytokine changes to resolve. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
If the patient has undergone a surgical procedure, she must be at least 8 weeks post-procedure.
English speaking
Medical clearance for participation provided by primary care physician or oncologist
Postmenopausal
Average fatigue over the past week of ≥ 3 on a 1 to 10 Likert scale or sleep dysfunction ≥ 1 on a 0 to 3 Likert scale
Participating, on average, in no more than 20 minutes of physical activity on two or fewer days per week during the past six months
Willing to abstain from "as needed" medications for 7 days prior to each blood draw. "As needed" medications are defined as any medicine (prescription or over-the-counter) that is taken sporadically as needed for specific complaints rather than taken at regularly scheduled intervals (e.g., daily).

Exclusion criteria

Metastatic or recurrent breast cancer
Inability to ambulate without assistance
Unstable angina
New York Heart Association class II, III, or IV congestive heart failure
Uncontrolled asthma
Interstitial lung disease
Current use of steroids
Having been told by a physician to only do exercise prescribed by a physician
Dementia or organic brain syndrome
Schizophrenia or active psychosis
Connective tissue or rheumatologic disease [i.e., Systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, progressive systemic sclerosis, CREST syndrome, polymyositis, dermatomyositis, vasculitis, polymyalgia rheumatic, temporal arteritis]
Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
Do not live or work less than 50 miles from the study site
Lack of transportation to the study site
Changes in usual medications expected during the study time period
Plan to move residence out of the local area during the 5 months of the study
Plan to travel out of the local area for vacation during the first 4 weeks of the intervention or plan to travel out of the local area for more than a week during the last 8 weeks of the intervention
Contraindication to participation in physical activity (i.e., moderate intensity walking and strength training with resistance bands)