Clinical trial · Interventional
Acupuncture for Aromatase Inhibitor Induced Joint Pain
Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, controlled, pilot study to determine the safety and efficacy of acupuncture as an adjunct to pharmacological treatment compared to pharmacological intervention alone for the treatment of musculoskeletal pain related to aromatase inhibitors (AI) in postmenopausal breast cancer patients. Twenty participants (20 in each arm) will be enrolled at the Breast Oncology clinic at Columbia University Medical Center (CUMC). Patients in the treatment arm will receive acupuncture administered twice weekly for six weeks and will be allowed to take pain medication as necessary. The control patients will initially receive pain medication alone, then will cross-over to the acupuncture arm after six weeks. The investigators hypothesize that acupuncture will reduce AI induced joint symptoms. The study will enroll a total of 40 patients, half of whom will be randomized to one of the two arms to receive acupuncture plus pharmacological treatment (arm A) or pharmacological treatment alone (arm B). Joint pain will be assessed by the BPI-SF score at baseline and six weeks. All patients will have a baseline BPI worst pain item (#2) ≥3 points on a scale of 0-10.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Procedure | — | UNRESOLVED |
| Sham Acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture Arm
- description
- Patients in the treatment arm will receive acupuncture administered twice weekly for six weeks and will be allowed to take pain medication as necessary.
- interventionNames
- Procedure: Acupuncture
- type
- SHAM_COMPARATOR
- label
- Control Arm
- description
- The control patients will receive a form of sham acupuncture, which will consist of superficial needling at nonspecific body points, administered twice weekly for six weeks.
- interventionNames
- Procedure: Sham Acupuncture
Primary outcomes (1)
- measure
- Change in Joint Pain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Age\>45 years * Postmenopausal status defined as cessation of menses for \>1 year or follicle- stimulating hormone (FSH)\>20 mIU/mL * History of stage I or II, hormone receptor-positive breast cancer * Currently taking a third-generation aromatase inhibitor (anastrazole, letrozole or exemestane) * Ongoing musculoskeletal pain in one or more joints (baseline BPI worst pain score \> 3 points on a scale of 0 to 10) * English-speaking * Signed informed consent EXCLUSION CRITERIA: * Previous treatment with acupuncture * Inflammatory, metabolic or neuropathic arthropathies * Bone fracture or surgery of the afflicted extremity during the past six months * Current narcotic use, corticosteroid therapy or cortisone injections * Severe concomitant illnesses or metastatic disease * Severe coagulopathy or bleeding disorder * Dermatological disease within the acupuncture area
References
Publications (0)
Data not yet available