Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

July 19, 2011 updated by: Nevada Cancer Institute

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. 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. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Nevada Cancer Institute
        • Contact:
        • Contact:
          • Karen Milligan, MD
          • Phone Number: 702-822-5433
        • Principal Investigator:
          • Karen Milligan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Exercise Regimen
Exercise instruction
No Intervention: Control Group
The control group will receive basic information on physical activity but not be instructed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Changes in CRP
The primary endpoint for this study change in C-reactive protein.

Secondary Outcome Measures

Outcome Measure
Measure Description
Change in laboratory values

Compare changes in:

  • Glucose
  • Insulin
  • Estradiol
  • Testosterone
Change in body composition
Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.
Quality of Life
Quality of Life will be measured and compared between the groups
Overall Survival
Comparing overall survival and progression free survival between groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nevada Cancer Institute

Collaborators

Vons

Investigators

  • Principal Investigator: Karen Milligan, MD, Nevada Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVCI 10-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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