Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Breast Clinic Strength and Range of Motion Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489125
• Other study ID #: CCCWFU 97305
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Start date: October 15, 2004
• Est. completion date: July 20, 2018

Study information

• Verified date: May 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care.

PURPOSE: This clinical trial is collecting information about strength and range of motion over time from women undergoing surgery for breast cancer.

Description:

OBJECTIVES:

• Collect data regarding diagnosis, type of surgery, receipt of adjuvant therapy, age, height, weight, waist circumference, arm strength, grip strength, shoulder range of motion, and physical activity participation from women undergoing surgery for breast cancer.

• Examine changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time in these patients.

• Determine differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy.

• Examine relationships between exercise participation, fitness, and body composition over time.

• Correlate data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures.

OUTLINE: This is a prospective, cohort study.

Patients submit data comprising demographic/medical information, anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and at 2 years after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

Inclusion Criteria:

• Diagnosis of breast cancer

• Stage I-IV disease

• Planning to undergo surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• physiologic testing
physical testing of range of motion, grip strength etc.

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of data before surgery, at each follow-up visit, and at 2 years after surgery		approximately 2 years
Primary	Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time		approximately 2 years
Primary	Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy		approximately 2 years
Primary	Relationships between exercise participation, fitness, and body composition over time		approximately 2 years
Primary	Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures		approximately 2 years