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

Official Title: “Acupuncture and Aromatase Inhibitor Related Arthralgia”

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.

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.

Intervention(s) in this Clinical Trial

• Procedure: acupuncture therapy
• Procedure: sham intervention
  • Placebo acupuncture

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Pain as measured by Brief Pain Inventory (BPI) pain severity score
  • Safety Issue?: No

Secondary Measures

• BPI pain-related interference
  • 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
  • Safety Issue?: No
• Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
  • 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
  • Safety Issue?: No

• 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Abramson Cancer Center of the University of Pennsylvania Other

Overall Clinical Trial Officials and Contacts

Jun Mao Principal Investigator Abramson Cancer Center of the University of Pennsylvania  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01013337

Study ID Number: UPCC 07109

ClinicalTrials.gov Identifier: NCT01013337

Health Authority: United States: Federal Government