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

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ClinicalTrials.gov Identifier: NCT00640666
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE March 13, 2008
First Posted Date  ICMJE March 21, 2008
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE March 2008
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Change in pro-inflammatory and anti-inflammatory cytokines [ Time Frame: baseline and 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
Change in pro-inflammatory and anti-inflammatory cytokines [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT00640666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Change in fatigue, sleep and muscle strength [ Time Frame: baseline and 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2008)
Change in fatigue, sleep and muscle strength [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Official Title  ICMJE Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE Behavioral: Exercise Behavior Change
Multidisciplinary
Other Names:
  • physical activity
  • exercise
Study Arms  ICMJE
  • Experimental: Physical activity intervention
    Behavior change intervention
    Intervention: Behavioral: Exercise Behavior Change
  • No Intervention: Standard of care with written materials
    Written materials
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2008)
40
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640666
Other Study ID Numbers  ICMJE ROG-SIU.003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Q Rogers, M.D., M.P.H. University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP