NCT01236417

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

November 5, 2010

Last Update Submit

April 12, 2012

Conditions

Breast CancerArthralgia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Feasibility of Multi-institutional study

    Length of the study

Study Arms (1)

Exercise

EXPERIMENTAL

Subjects will be participating in a home-based flexibility and exercise program

Behavioral: Exercising block

Interventions

Exercising blockBEHAVIORAL

Exercising for 8 weeks using an elastic band

Exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsArthralgia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tracy O'Connor, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 8, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

US(1)