Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Nevada Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vons
Information provided by:
Nevada Cancer Institute
ClinicalTrials.gov Identifier:
NCT01157130
First received: July 1, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Early Stage Breast Cancer (Stage 0-III)
Other: Exercise Regimen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

Resource links provided by NLM:


Further study details as provided by Nevada Cancer Institute:

Primary Outcome Measures:
  • Changes in CRP [ Designated as safety issue: No ]
    The primary endpoint for this study change in C-reactive protein.


Secondary Outcome Measures:
  • Change in laboratory values [ Designated as safety issue: No ]

    Compare changes in:

    • Glucose
    • Insulin
    • Estradiol
    • Testosterone

  • Change in body composition [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    Quality of Life will be measured and compared between the groups

  • Overall Survival [ Designated as safety issue: No ]
    Comparing overall survival and progression free survival between groups.


Estimated Enrollment: 100
Study Start Date: July 2010
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157130

Locations
United States, Nevada
Nevada Cancer Institute Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Breanne Eddington    702-821-0062    beddington@nvcancer.org   
Contact: Karen Milligan, MD    702-822-5433      
Principal Investigator: Karen Milligan, MD         
Sponsors and Collaborators
Nevada Cancer Institute
Vons
Investigators
Principal Investigator: Karen Milligan, MD Nevada Cancer Institute
  More Information

No publications provided

Responsible Party: Karen Milligan, MD, Nevada Cancer Institute
ClinicalTrials.gov Identifier: NCT01157130     History of Changes
Other Study ID Numbers: NVCI 10-09
Study First Received: July 1, 2010
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nevada Cancer Institute:
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)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014