Physical Activity, Fatigue, Sleep, and Inflammation

NCT01147367 | Completed

• 2 other identifiers: ROG-SCCI-10-004-1R21CA135017-01A2
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

exercise; breast cancer; physical activity; fatigue; sleep dysfunction; cytokines; muscle strength; inflammation

Outcome Measures

Primary Outcomes (4)

• physical activity

  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.

  baseline and 3 months

• muscle strength

  The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention.

  baseline and 3 months

• fatigue

  The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention.

  baseline and 3 months

• sleep dysfunction

  The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention.

  baseline and 3 months

Secondary Outcomes (1)

• inflammatory markers (serum cytokine levels)

  baseline and 3 months

Study Arms (2)

Control

NO INTERVENTION

no physical activity intervention

Exercise intervention

EXPERIMENTAL

3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands

Behavioral: 3 month physical activity intervention

Interventions

3 month physical activity intervention BEHAVIORAL

3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands

Also known as: exercise

Exercise intervention

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (2)

• Rogers LQ, Vicari S, Trammell R, Hopkins-Price P, Fogleman A, Spenner A, Rao K, Courneya KS, Hoelzer KS, Robbs R, Verhulst S. Biobehavioral factors mediate exercise effects on fatigue in breast cancer survivors. Med Sci Sports Exerc. 2014 Jun;46(6):1077-88. doi: 10.1249/MSS.0000000000000210.

  PMID: 24212124 RESULT

• Rogers LQ, Fogleman A, Trammell R, Hopkins-Price P, Spenner A, Vicari S, Rao K, Courneya KS, Hoelzer K, Robbs R, Verhulst S. Inflammation and psychosocial factors mediate exercise effects on sleep quality in breast cancer survivors: pilot randomized controlled trial. Psychooncology. 2015 Mar;24(3):302-10. doi: 10.1002/pon.3594. Epub 2014 Jun 11.

  PMID: 24916951 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Fatigue; Parasomnias; Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura Q Rogers, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)