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Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study) (CICK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640666
First Posted: March 21, 2008
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
  Purpose
It is important to confirm health benefits experienced by breast cancer survivors after participation in a physical activity behavior change intervention. One such potential benefit is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk. Because little is known about how physical activity behavior change interventions influence inflammation in breast cancer survivors, the investigators study will measure inflammation with blood markers known as cytokines among breast cancer survivors before and after a physical activity intervention. Such information has the potential to lead to improved physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer risk in breast cancer survivors.

Condition Intervention
Breast Cancer Behavioral: Exercise Behavior Change

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)

Resource links provided by NLM:


Further study details as provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in pro-inflammatory and anti-inflammatory cytokines [ Time Frame: baseline and 3 months ]

Secondary Outcome Measures:
  • Change in fatigue, sleep and muscle strength [ Time Frame: baseline and 3 months ]

Enrollment: 30
Study Start Date: March 2008
Study Completion Date: March 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity intervention
Behavior change intervention
Behavioral: Exercise Behavior Change
Multidisciplinary
Other Names:
  • physical activity
  • exercise
No Intervention: Standard of care with written materials
Written materials

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are not currently receiving (and do not plan to receive during the study duration) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
  • If the patient has undergone a surgical procedure, must be at least 8 weeks post-procedure.
  • English speaking.
  • Medical clearance for participation provided by primary care physician or oncologist.

Exclusion Criteria:

  • Diagnosis of dementia or organic brain syndrome.
  • Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
  • Contraindication to participation in a regular physical activity program.
  • Metastatic or recurrent disease
  • Inability to ambulate
  • Engaged in ≥ 60 minutes of vigorous physical activity or ≥ 150 minutes of moderate plus vigorous activity per week during the past month.
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Participant does not live or work within 50 miles of the study site.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640666


Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9636
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Laura Q Rogers, M.D., M.P.H. University of Alabama at Birmingham
  More Information

Additional Information:
Publications:
Responsible Party: Laura Q. Rogers, MD, MPH, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00640666     History of Changes
Other Study ID Numbers: ROG-SIU.003
First Submitted: March 13, 2008
First Posted: March 21, 2008
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
Breast cancer
Exercise
Biomarkers