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NCT05458284 · ClinicalTrials.gov registry record · Phase 2
The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
A Phase 2 study of Breast Cancer and Taxane-Induced Peripheral Neuropathy, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 7
- Study locations
NCT05458284: Active Phase 2 study of Breast Cancer and Taxane-Induced Peripheral Neuropathy, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05458284 is a Phase 2 study of Breast Cancer and Taxane-Induced Peripheral Neuropathy that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 80 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05458284, a Phase 2 study of Breast Cancer and Taxane-Induced Peripheral Neuropathy, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 7
- Study locations
Study Summary
Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.
Primary Outcome
Evaluate the effectiveness of real acupuncture versus sham acupuncture in preventing TIPN progression as measured by the Neuropathic Pain Scale (NPS) in patients with early stage breast cancer who are receiving curative intent weekly taxane containing regimen and who have grade ≥ 1 TIPN
Conditions Studied
Interventions
- OTHER Sham Acupuncture
- PROCEDURE Real Acupuncture
Study Locations (7)
New York
- Memorial Sloan Kettering Suffolk- Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Rockville Centre
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-07-11 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What the registry record for NCT05458284 still lists
NCT05458284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Sham Acupuncture is the first listed.
NCT05458284 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05458284 about?
NCT05458284 is a clinical study titled "The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment". Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can p...
What is the current status of trial NCT05458284?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2022-07-11. Estimated completion is 2026-07.
What conditions does trial NCT05458284 study?
This clinical trial studies the following conditions: Breast Cancer, Taxane-Induced Peripheral Neuropathy.
What interventions are being tested in trial NCT05458284?
The interventions under investigation include: Sham Acupuncture (OTHER), Real Acupuncture (PROCEDURE).
Who is sponsoring clinical trial NCT05458284?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05458284 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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