Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

Breast Cancer Clinical Trial

Official title:

Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236417
• Other study ID #: I 169310
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: April 12, 2012
• Start date: March 2010

Study information

• Verified date: April 2012
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.

• Patients must complain of mild to moderate arthralgia.

• Ability to understand and sign informed consent.

• Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.

Exclusion Criteria:

• Inability to comply with study requirements.

• Metastatic breast cancer.

• Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.

• Rheumatoid arthritis.

• History of MI, angina or congestive heart failure.

• Pregnant or lactating females.

• Patients that are high risk for moderate exercise based on ACSM risk classification.

• Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.

• Morbidly obese with BMI = 40

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Exercising block
Exercising for 8 weeks using an elastic band

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of exercise	To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors.	Length of study	No
Secondary	Feasibility of Multi-institutional study	To perform a pilot to access the feasibility of a multi-institutional approach	Length of the study	No