Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain - Full Text View

Sponsor:	Abramson Cancer Center of the University of Pennsylvania
Information provided by:	Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01013337

Purpose

RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors.

PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.

Condition	Intervention	Phase
Breast Cancer Recurrent Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer	Procedure: acupuncture therapy Procedure: sham intervention	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Acupuncture and Aromatase Inhibitor Related Arthralgia

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Acupuncture Acute Bronchitis Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:

Pain as measured by Brief Pain Inventory (BPI) pain severity score [ Designated as safety issue: No ]

Secondary Outcome Measures:

BPI pain-related interference [ Designated as safety issue: No ]
Arthritis/disability specific outcomes as assessed by WOMAC index for lower extremities, quick D.A.S.H. for upper extremities, and the Physical Performance Test, 9-item [ Designated as safety issue: No ]
Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC) [ Designated as safety issue: No ]
Other coexisting symptoms such as fatigue, psychological distress, and insomnia as assessed by the Brief Fatigue Inventory (BFI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index, and City of Hope Quality of Life Questionnaire [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I (Acupuncture) Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).	Procedure: acupuncture therapy Other Name: acupuncture
Sham Comparator: Arm II (Placebo) Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.	Procedure: sham intervention Placebo acupuncture
No Intervention: Arm III (Control) Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the overall effect of acupuncture for reducing arthralgia among breast cancer survivors (BCS) receiving AIs.

II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS receiving AIs.

III. To elucidate the relationship between response expectancy measured by the Acupuncture Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of BPI pain severity score at the end of intervention.

SECONDARY OBJECTIVES:

I. To explore the effects of acupuncture on other common symptoms including fatigue, insomnia, and psychological distress among BCS who experience joint pain.

II. To determine the correlation among pain and fatigue, insomnia, and psychological distress using previously validated instruments.

III. To explore the effects of acupuncture on quality of life among BCS who experience joint pain.

IV. To explore the effect of acupuncture on objective measure of sleep and activity.

V. To identify potential genetic determinants to response to acupuncture.

OUTLINE:

Patients are randomized to 1 of 3 treatment arms.

ARM I (Acupuncture): Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).

ARM II (Placebo): Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.

ARM III (Control): Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.

After completion of study treatment, patients are followed at 4 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion

History of stage I, II, or III breast cancer
Visit with oncologist within the previous 3-month period and free of disease by clinical examination and history
Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as per chart abstraction
Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40 mlU/mL
Can understand written English
Having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
Having had at least 15 days with pain in the preceding 30 days
Having had joint pain for at least 3 months
Joint pain attributed to the use of aromatase inhibitors
Willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control

Exclusion

Women with metastatic (stage IV) breast cancer
Women having finished chemotherapy or radiation therapy less than 4 weeks prior to enrollment
History of bleeding disorder
Joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout, pseudo gout)
Having severe pain or non-inflammatory arthralgia prior to AI initiation per patient's history
Surgery or joint injection involving the treatment joint within the last 3 months
Have previously participated in the acupuncture trial for hot flashes in the last year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013337

Locations

United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jun Ja Mao 215-615-4330 jun.mao@uphs.upenn.edu
Principal Investigator: Jun Ja Mao

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator:

Jun Mao

Abramson Cancer Center of the University of Pennsylvania

More Information

No publications provided

Responsible Party:	Mao, Jun, Abramson Cancer Center of The University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01013337 History of Changes
Other Study ID Numbers:	UPCC 07109, NCI-2009-01358
Study First Received:	November 12, 2009
Last Updated:	May 17, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012