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Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

Primary Purpose

Early Stage Breast Cancer (Stage 0-III)

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Regimen

About this trial

This is an interventional supportive care trial for Early Stage Breast Cancer (Stage 0-III) focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Eligible participants will not be included if they have:

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

Sites / Locations

Nevada Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in CRP

The primary endpoint for this study change in C-reactive protein.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01157130

First Posted

July 1, 2010

Last Updated

July 19, 2011

Sponsor

Nevada Cancer Institute

Collaborators

Vons

1. Study Identification

Unique Protocol Identification Number

NCT01157130

Brief Title

Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Nevada Cancer Institute

Collaborators

Vons

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Stage Breast Cancer (Stage 0-III)

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)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Exercise Regimen

Intervention Description

Exercise instruction

Primary Outcome Measure Information:

Title

Changes in CRP

Description

The primary endpoint for this study change in C-reactive protein.

Secondary Outcome Measure Information:

Title

Change in laboratory values

Description

Compare changes in: Glucose Insulin Estradiol Testosterone

Title

Change in body composition

Description

Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.

Title

Quality of Life

Description

Quality of Life will be measured and compared between the groups

Title

Overall Survival

Description

Comparing overall survival and progression free survival between groups.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Consent to participate in study Women aged 18 and older Stage 0 to III breast cancer prior to any treatment and at time of diagnosis Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy Adequate fitness to participate in a physical activity as assessed by the investigator Willing and able to participate in a prescribed exercise program Exclusion Criteria: Metastatic breast cancer (Stage IV) Initiation of treatment regimen prior to enrollment Treatment for breast cancer not requiring chemotherapy or radiation therapy Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential). Currently lactating Do not read, understand, or speak English Eligible participants will not be included if they have: known cardiac disease, uncontrolled hypertension, uncontrolled thyroid disease, diabetes mellitus, mental illness, infection, immune or endocrine abnormality, body weight reduction I10% in past 6 months, and positive exercise stress test. Major surgery within last 6 months that requires exercise restriction

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Milligan, MD

Organizational Affiliation

Nevada Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nevada Cancer Institute

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Breanne Eddington

Phone

702-821-0062

beddington@nvcancer.org

First Name & Middle Initial & Last Name & Degree

Karen Milligan, MD

Phone

702-822-5433

First Name & Middle Initial & Last Name & Degree

Karen Milligan, MD

12. IPD Sharing Statement

Links:

URL

http://www.nevadacancerinstitute.org/

Description

Nevada Cancer Institute

Learn more about this trial

Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

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