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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3 month physical activity intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring exercise, breast cancer, physical activity, fatigue, sleep dysfunction, cytokines, muscle strength, inflammation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Southern Illinois University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Exercise intervention

Arm Description

no physical activity intervention

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

inflammatory markers (serum cytokine levels)
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.

Full Information

First Posted
June 17, 2010
Last Updated
March 7, 2016
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01147367
Brief Title
Physical Activity, Fatigue, Sleep, and Inflammation
Acronym
ABLE
Official Title
Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
exercise, breast cancer, physical activity, fatigue, sleep dysfunction, cytokines, muscle strength, inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
no physical activity intervention
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Intervention Type
Behavioral
Intervention Name(s)
3 month physical activity intervention
Other Intervention Name(s)
exercise
Intervention Description
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Primary Outcome Measure Information:
Title
physical activity
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.
Time Frame
baseline and 3 months
Title
muscle strength
Description
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.
Time Frame
baseline and 3 months
Title
fatigue
Description
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.
Time Frame
baseline and 3 months
Title
sleep dysfunction
Description
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.
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
inflammatory markers (serum cytokine levels)
Description
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.
Time Frame
baseline and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Q Rogers, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24212124
Citation
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.
Results Reference
result
PubMed Identifier
24916951
Citation
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.
Results Reference
result

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Physical Activity, Fatigue, Sleep, and Inflammation

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