ACTIVE_NOT_RECRUITING

The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial

Quick Facts

Study Start:2022-07-11
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05458284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English or Spanish-proficient men and women aged ≥18 years
  2. * Histological diagnoses of invasive carcinoma of the breast
  3. * Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care
  4. * TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
  5. * ≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
  6. * Willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period
  7. * Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
  1. * Pre-existing peripheral neuropathy within 28 days of screening consent
  2. * Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
  3. * Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
  4. * Use of acupuncture for symptom management within 28 days of intervention consent

Contacts and Locations

Principal Investigator

Jun Mao, MD, MSCE
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk- Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jun Mao, MD, MSCE, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-11
Study Completion Date2025-07

Study Record Updates

Study Start Date2022-07-11
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Acupuncture
  • Peripheral Neuropathy
  • 22-197

Additional Relevant MeSH Terms

  • Breast Cancer
  • Taxane-Induced Peripheral Neuropathy