Recruiting

Breast Cancer Rehabilitation

Sponsor:

Nevada Cancer Institute

Code:

NCT01157130

Conditions

Early Stage Breast Cancer (Stage 0-III)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Regimen

Study Details

Brief summary:

The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.

Conditions

Early Stage Breast Cancer (Stage 0-III)

Study ID

NCT01157130

Start date

Jul, 2010

Status verified date

Jul, 2011

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Consent to participate in study
2. Women aged 18 and older
3. Stage 0 to III breast cancer prior to any treatment and at time of diagnosis
4. Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy
5. Adequate fitness to participate in a physical activity as assessed by the investigator
6. Willing and able to participate in a prescribed exercise program

Exclusion Criteria:

1. Metastatic breast cancer (Stage IV)
2. Initiation of treatment regimen prior to enrollment
3. Treatment for breast cancer not requiring chemotherapy or radiation therapy
4. Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential).
5. Currently lactating
6. Do not read, understand, or speak English

Eligible participants will not be included if they have:

1. known cardiac disease,
2. uncontrolled hypertension,
3. uncontrolled thyroid disease,
4. diabetes mellitus,
5. mental illness,
6. infection,
7. immune or endocrine abnormality,
8. body weight reduction I10% in past 6 months, and
9. positive exercise stress test.
10. Major surgery within last 6 months that requires exercise restriction

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group.

no intervention: Control Group

The control group will receive basic information on physical activity but not be instructed.

Interventions

Exercise Regimen

Exercise instruction

Primary outcome measure

  • Changes in CRP [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Nevada Cancer Institute

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Karen Milligan, MD

702-822-5433

Principal Investigator:

Karen Milligan, MD

More Information

Sponsor

Nevada Cancer Institute

Last update posted

Jul 20, 2011

Last verified

Jul, 2011

Keywords

  • Breast Cancer
  • Exercise
  • CRP
  • C-reactive protein
  • BMI
  • Nevada Cancer Institute
  • Rehabilitation
  • Prescriptive exercise
  • Physical Activity
  • DEXA
  • Obesity
  • lifestyle intervention
  • Early Stage Breast Cancer Patients (stage 0-III)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nevada Cancer Institute on 2011-07-20.