Clinical trial · Interventional
Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel
A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
NCT01050075CI-TRIAL-00030198terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit patients in the 6 month extension allowed.
Summary
Brief summary (as posted)
RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.
Conditions
Conditions (6)
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 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acupuncture therapy | Other | — | UNRESOLVED |
| management of therapy complications | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
- interventionNames
- Other: acupuncture therapy
- Other: questionnaire administration
- Other: management of therapy complications
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
- interventionNames
- Other: acupuncture therapy
- Other: questionnaire administration
- Other: management of therapy complications
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion
* Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
* Performance ECOG 0-2 (Karnofsky Performance Status \>= 60%)
* Life expectancy of greater than 6 months
* Ability to understand and the willingness to sign a written informed consent document
Exclusion
* Patients with radiologically confirmed stage IV breast cancer
* Patients who had acupuncture in the previous 8 weeks
* Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
* Patients with needle phobia
* Patients who experienced any peripheral neuropathy prior to chemotherapy
* Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
* Patients with diabetesReferences
Publications (0)
Data not yet available
No reference posted for this study.