Acupuncture in Treating Women With Stage I, Stage II, or Stage III Breast Cancer With Aromatase Inhibitor-Related Joint Pain
Acupuncture and Aromatase Inhibitor Related Arthralgia
2 other identifiers
interventional
76
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started May 2009
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2016
CompletedApril 8, 2020
April 1, 2020
3.4 years
November 12, 2009
April 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pain as measured by Brief Pain Inventory (BPI) pain severity score
Secondary Outcomes (4)
BPI pain-related interference
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
Patient perceived clinical importance of acupuncture for AI-related arthralgia as assessed by Patient Global Impression of Change (PGIC)
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
Study Arms (3)
Arm I (Acupuncture)
EXPERIMENTALPatients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).
Arm II (Placebo)
SHAM COMPARATORPatients 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)
NO INTERVENTIONWait-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
Bao T, Li SQ, Dearing JL, Piulson LA, Seluzicki CM, Sidlow R, Mao JJ. Acupuncture versus medication for pain management: a cross-sectional study of breast cancer survivors. Acupunct Med. 2018 Apr;36(2):80-87. doi: 10.1136/acupmed-2017-011435. Epub 2018 Feb 10.
PMID: 29440043DERIVEDMao JJ, Xie SX, Farrar JT, Stricker CT, Bowman MA, Bruner D, DeMichele A. A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use. Eur J Cancer. 2014 Jan;50(2):267-76. doi: 10.1016/j.ejca.2013.09.022. Epub 2013 Oct 24.
PMID: 24210070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Mao
Abramson Cancer Center at Penn Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2012
Study Completion
April 21, 2016
Last Updated
April 8, 2020
Record last verified: 2020-04