Acupuncture in the Management of Post Operative Symptoms... | NCT00419822

Studies
Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Patients

NCT00419822

Sponsor

Legacy Health System

Status

Completed

Last Update Posted

Jul 4, 2011Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Acupuncture
Sham Acupuncture
Patient to receive standard care without Acupuncture or Sham Acupuncture.

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

May 2010

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

Sep 2006

Primary Completion Date

Mar 2011Actual

Completion Date

Not provided

First Submitted Date

Jan 8, 2007

First Submission Date that Met QC Criteria

Jan 8, 2007

First Posted Date

Jan 9, 2007Estimated

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

Jun 30, 2011

Last Update Posted Date

Jul 4, 2011Estimated

Description Module

Brief Summary

This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).

Detailed Description

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Acupuncture	Active Comparator	Procedure: Acupuncture
Sham Acupuncture	Sham Comparator	Procedure: Sham Acupuncture
Standard of Care	Placebo Comparator	Other: Patient to receive standard care without Acupuncture or Sham Acupuncture.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure	6 Acupuncture visits	Acupuncture
Sham Acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the difference in pain and range of motion		3 months after surgery
Determine the difference in function		3 months after surgery
Determine the difference in quality of life		3 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female subjects
Expected survival at least 6 months or greater
Has had surgery with axillary dissection
Greater than 6 nodes removed during surgery
Greater than 21 years of age

Exclusion Criteria:

Previous mastectomy
Double mastectomy at the time of current axillary surgery
Any diagnoses of autoimmune disease
Pregnant or lactating women
Unable to provide written informed consent
Suspected or diagnosed fibromyalgia
Previous shoulder injuries for the specific arm that will undergo axillary dissection
Known or suspected drug or alcohol abuse as determined by the investigator
Decreased range of motion (ROM) as evidenced on standard preoperative exam
Previous acupuncture (lifetime)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 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
Nathalie Johnson, MD	Legacy Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Legacy Good Samaritan Hospital and Medical Center		Portland	Oregon	97210	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided