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


N/A
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in pro-inflammatory and anti-inflammatory cytokines

Outcome Time Frame:

baseline and 3 months

Safety Issue:

No

Principal Investigator

Laura Q Rogers, M.D., M.P.H.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southern Illinois University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

ROG-SIU.003

NCT ID:

NCT00640666

Start Date:

March 2008

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Exercise
  • Biomarkers
  • Breast Neoplasms

Name

Location

Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658