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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Exercise Behavior Change

• Registration Number: NCT00640666
• Lead Sponsor: University of Alabama at Birmingham

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 available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-13
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-21
• Primary Completion: 2013-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-09
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physical activity intervention	Exercise Behavior Change	Behavior change intervention

Primary Outcome Measures

Name	Time	Method
Change in pro-inflammatory and anti-inflammatory cytokines	baseline and 3 months

Secondary Outcome Measures

Name	Time	Method
Change in fatigue, sleep and muscle strength	baseline and 3 months

Trial Locations

Locations (1)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States