Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

NCT01157130 | Unknown DMC

• 1 other identifier: NVCI 10-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

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)

Outcome Measures

Primary Outcomes (1)

• Changes in CRP

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

Secondary Outcomes (4)

• Change in laboratory values

• Change in body composition

• Quality of Life

• Overall Survival

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Exercise Regimen OTHER

Exercise instruction

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nevada Cancer Institute: lead
• Vons: collaborator

Study Sites (1)

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

RECRUITING

Related Links

• Nevada Cancer Institute

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Obesity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Milligan, MD

  Nevada Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2010
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)