Clinical trial · Interventional
Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women
Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast or Gynecologic Cancers: Mechanisms of Action and Feasibility
NCT04067544CI-TRIAL-00088194terminatedN/AResults postedClinicalTrials.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): Unforeseen complications due to COVID-19 and funding
Summary
Brief summary (as posted)
This pilot study aims to evaluate the feasibility to conduct a study of acupuncture treatment (AT) for Chemotherapy-Induced Peripheral Neuropathy (CIPN) at Huntsman Cancer Institute and to investigate changes in physiological biomarkers when using acupuncture to treat CIPN.
Conditions
Conditions (3)
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 Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acupuncture Treatment
- description
- All participants receive 10 acupuncture treatments over the course of 8 weeks.
- interventionNames
- Device: Acupuncture
Primary outcomes (4)
- measure
- Mean Monthly Enrollment
- timeFrame
- 7 Months
- description
- We calculated the mean number of participants who enrolled per month while the study was open to accrual.
- measure
- Number of Participants Compliant With Treatment
- timeFrame
- 7 Months
- description
- Participant retention was defined as the number of participants who attended at least 8 out of 10 AT sessions and completed both fMRI scans
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Female age 18 or older. * Histologically proven breast, uterine, cervical or ovarian cancer of any stage. * Received either (1) a Paclitaxel treatment dose of at least 480 mg/m2 paclitaxel as a single or combination agent or (2) a Docetaxel treatment dose of at least 150 mg/m2 docetaxel as a single or combination agent. Treatment must be completed at least 3 months prior to enrollment. * Eligible participants report at least 1 month of altered sensation and/or pain in the feet (with or without presence in one or both hands) with a score of greater than or equal to 20 for CIPN on the sensory subscale of the CIPN-20 (scale 0-100). * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * Eastern Cooperative Oncology Group (ECOG) status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, \<50% in bed during the day). Exclusion Criteria: * Preexisting neuropathy due to other identified etiologies includes diabetes, vitamin B12 deficiency, or alcoholism. * Having received more than 6 acupuncture treatments for any condition in the last six months. * Participants with claustrophobia, pacemakers, non-MRI compatible breast expanders or port-a-caths, neurostimulator devices, current pregnancy, exposure to shrapnel, left-handedness, or otherwise unsafe for MRI scanning.
References
Publications (0)
Data not yet available
No reference posted for this study.