Exercise Intervention in Breast Cancer Patients With Trea... | NCT01236417

Studies
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

NCT01236417

Sponsor

Roswell Park Cancer Institute

Status

Completed

Last Update Posted

Apr 13, 2012Estimated

Enrollment

27Actual

Phase

Not Applicable

Conditions

Breast Cancer
Arthralgia

Interventions

Exercising block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Not provided

First Submitted Date

Nov 5, 2010

First Submission Date that Met QC Criteria

Nov 5, 2010

First Posted Date

Nov 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2012

Last Update Posted Date

Apr 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Experimental	Subjects will be participating in a home-based flexibility and exercise program	Behavioral: Exercising block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercising block	Behavioral	Exercising for 8 weeks using an elastic band	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Feasibility of Multi-institutional study	To perform a pilot to access the feasibility of a multi-institutional approach	Length of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tracy O'Connor, MD	Roswell Park Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roswell Park Cancer Institute		Buffalo	New York	14263	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D018771	Arthralgia

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided