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Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain

Primary Purpose

Breast Cancer, Menopausal Symptoms, Pain

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

acupuncture therapy

pain therapy

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring menopausal symptoms, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, breast cancer, pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
Concurrent therapy with anastrozole for the adjuvant treatment of breast cancer
Must have moderate or worse arthralgia, as defined by a baseline WOMAC pain scale score ≥ 48
- Patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole
Hormone receptor-positive disease

PATIENT CHARACTERISTICS:

Post-menopausal status meeting the following criteria:
- At least 12 months without spontaneous menstrual bleeding
- History of bilateral salpingo-oophorectomy with or without hysterectomy
- Age > 55 with hysterectomy with or without oophorectomy
- Age < 55 with hysterectomy without oophorectomy or with unknown status, and serum FSH in post-menopausal range within the past 4 weeks
Not needle phobic
Patients with a contraindication to NSAIDs (i.e., prior gastrointestinal bleed secondary to NSAIDs or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Concurrent chronic narcotics or NSAIDs allowed, but doses must be stable for ≥ the past month
Concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months
At least 6 months since prior acupuncture
No prior acupuncture for aromatase inhibitor-associated pain syndrome

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks.

Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I.

Outcomes

Primary Outcome Measures

Improvement in pain, as defined by the WOMAC global score at 6 weeks

Secondary Outcome Measures

Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels

Menopausal symptoms as defined by the FACT-ES

Full Information

NCT ID

NCT00892268

First Posted

May 1, 2009

Last Updated

April 23, 2010

Sponsor

University of Arizona

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00892268

Brief Title

Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain

Official Title

Acupuncture for the Treatment of Aromatase Inhibitor Associated Joint Pain in Post-Menopausal Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Terminated

Why Stopped

Poor accural

Study Start Date

January 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Arizona

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Acupuncture may reduce joint pain in postmenopausal women with breast cancer. It is not yet known whether acupuncture is more effective than standard therapy analgesics in decreasing joint pain caused by aromatase inhibitors. PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works compared with medication in reducing pain in postmenopausal women with breast cancer and joint pain.

Detailed Description

OBJECTIVES: Primary To evaluate the efficacy of acupuncture in reducing pain, defined by improvements in overall WOMAC score at 6 weeks, in post-menopausal women with breast cancer and aromatase inhibitor (AI)-associated arthralgia. Secondary To identify biologic correlates to acupuncture efficacy in this specific syndrome of AI-associated pain. To evaluate the efficacy of acupuncture in these patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms: Arm I: Patients undergo acupuncture for 20-30 minutes, on the appropriate pain points on the anterior portion of the body alternating with posterior portion of the body, thrice weekly for 2 weeks and then twice weekly for 3 weeks. Arm II: Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I. Patients are assessed periodically for improvement in pain, menopausal symptoms, and overall quality of life by the WOMAC, Brief Pain Inventory, and FACT-ES questionnaires. Blood samples are collected at baseline, 6 weeks, 3 months, and 6 months for biomarker studies of brain-derived neurotrophic factor and serotonin-transporter gene polymorphisms levels by ELISA. After completion of study therapy, patients are followed at 1 week, 6 weeks, 3 months, and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Menopausal Symptoms, Pain

Keywords

menopausal symptoms, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, breast cancer, pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Arm Title

Arm II

Arm Type

Active Comparator

Arm Description

Patients receive standard-of-care analgesics (i.e., NSAIDs, narcotics, acetaminophen, or other) for 5 weeks. Patients not responding to analgesia may cross over to arm I.

Intervention Type

Procedure

Intervention Name(s)

acupuncture therapy

Intervention Description

Undergo acupuncture

Intervention Type

Procedure

Intervention Name(s)

pain therapy

Intervention Description

Receive standard care

Primary Outcome Measure Information:

Title

Improvement in pain, as defined by the WOMAC global score at 6 weeks

Secondary Outcome Measure Information:

Title

Acupuncture efficacy as defined by bio-correlates, e.g., changes in BDNF and STGP levels

Title

Menopausal symptoms as defined by the FACT-ES

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of breast cancer Concurrent therapy with anastrozole for the adjuvant treatment of breast cancer Must have moderate or worse arthralgia, as defined by a baseline WOMAC pain scale score ≥ 48 Patients with other underlying pain syndromes (e.g., osteoarthritis) are eligible, but the arthralgia must have worsened since starting anastrozole Hormone receptor-positive disease PATIENT CHARACTERISTICS: Post-menopausal status meeting the following criteria: At least 12 months without spontaneous menstrual bleeding History of bilateral salpingo-oophorectomy with or without hysterectomy Age > 55 with hysterectomy with or without oophorectomy Age < 55 with hysterectomy without oophorectomy or with unknown status, and serum FSH in post-menopausal range within the past 4 weeks Not needle phobic Patients with a contraindication to NSAIDs (i.e., prior gastrointestinal bleed secondary to NSAIDs or severe renal insufficiency) are eligible, but will be treated with alternative analgesics such as narcotics or acetaminophen PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent chronic narcotics or NSAIDs allowed, but doses must be stable for ≥ the past month Concurrent antidepressant medications allowed, but doses must be stable for ≥ the past 3 months At least 6 months since prior acupuncture No prior acupuncture for aromatase inhibitor-associated pain syndrome

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leona B. Downey, MD

Organizational Affiliation

University of Arizona

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Acupuncture or Medication in Reducing Pain in Postmenopausal Women With Breast Cancer and Joint Pain

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