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Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms


N/A
30 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

physical activity

Outcome Description:

The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention.

Outcome Time Frame:

baseline and 3 months

Safety Issue:

No

Principal Investigator

Laura Q Rogers, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

ROG-SCCI-10-004-1

NCT ID:

NCT01147367

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • exercise
  • breast cancer
  • physical activity
  • fatigue
  • sleep dysfunction
  • cytokines
  • muscle strength
  • inflammation
  • Breast Neoplasms
  • Inflammation

Name

Location

Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658