Clinical trial NCT00640666: Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Official title: Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Exercise
Biomarkers
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Change in pro-inflammatory and anti-inflammatory cytokines
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Change in fatigue, sleep and muscle strength
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Q Rogers, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers LQ, Markwell SJ, Courneya KS, McAuley E, Verhulst S. Physical activity type and intensity among rural breast cancer survivors: patterns and associations with fatigue and depressive symptoms. J Cancer Surviv. 2011 Mar;5(1):54-61. doi: 10.1007/s11764-010-0160-8. Epub 2010 Nov 26.
citation: Rogers LQ, Vicari S, Courneya KS. Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Cancer Nurs. 2010 Nov-Dec;33(6):E10-7. doi: 10.1097/NCC.0b013e3181db699d.
citation: Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
citation: Rogers LQ, Fogleman A, Trammell R, Hopkins-Price P, Vicari S, Rao K, Edson B, Verhulst S, Courneya KS, Hoelzer K. Effects of a physical activity behavior change intervention on inflammation and related health outcomes in breast cancer survivors: pilot randomized trial. Integr Cancer Ther. 2013 Jul;12(4):323-35. doi: 10.1177/1534735412449687. Epub 2012 Jul 24.