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 |
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Recruitment Status :
Completed
First Posted : March 21, 2008
Last Update Posted : May 12, 2015
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Sponsor:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Behavioral: Exercise Behavior Change | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| 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) |
| Study Start Date : | March 2008 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | March 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Physical activity intervention
Behavior change intervention
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Behavioral: Exercise Behavior Change
Multidisciplinary
Other Names:
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No Intervention: Standard of care with written materials
Written materials
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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 ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| 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.
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 |
Additional Information:
Publications of Results:
Other 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 Posted: | March 21, 2008 Key Record Dates |
| Last Update Posted: | May 12, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
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Breast cancer Exercise Biomarkers |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |