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Completed

NCT Number: NCT00640666

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9636, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Behavior Change

Behavioral

Multidisciplinary

Other names: physical activity, exercise

Primary outcomes

  1. Change in pro-inflammatory and anti-inflammatory cytokines

    Time frame: baseline and 3 months

Secondary outcomes

  1. Change in fatigue, sleep and muscle strength

    Time frame: baseline and 3 months

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: CICK

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
Mar 21, 2008
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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