Acupuncture for Symptoms of Nerve Damage

July 20, 2023 updated by: Memorial Sloan Kettering Cancer Center

Acupuncture for Persistent Chemotherapy-induced Peripheral Neuropathy Symptoms in Solid Tumor Survivors: A Pilot Study

The purpose of this study is to compare the effects of real acupuncture with placebo acupuncture or usual care on symptoms of nerve damage from chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Commack
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English-speaking
  • Age ≥ 18 years old
  • Solid tumor survivors with no evidence of disease
  • Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale (NRS)
  • Have completed neurotoxic chemotherapy at least 3 months prior to enrollment
  • If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)

Exclusion Criteria:

  • Patients with a pacemaker
  • Prior acupuncture treatment within 5 years of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture Treatment Group
Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.
Procedure: Acupuncture
The acupuncture group will undergo 8 weeks of outpatient acupuncture or sham acupuncture treatments (twice weekly for 2 weeks, then weekly for 6 weeks, 10 treatments in total). The investigators have designed this approach to standardize acupuncture treatment for future broad use; it is based on the understanding that CIPN is a global symptom complex rather than individual isolated or local symptoms.
Behavioral: questionnaires
FACT/GOG-Ntx, Neuropathic Pain Scale (NPS),Treatment Expectancy Scale (TES), Quantitative Sensory Testing (QST), Insomnia Severity Index (ISI), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI)
Placebo Comparator: Sham Acupuncture Treatment Group
Ten sham acupuncture treatments over the course of eight weeks, with twice weekly sham acupuncture treatments for the first two weeks, and then weekly sham acupuncture treatment thereafter.
Behavioral: questionnaires
FACT/GOG-Ntx, Neuropathic Pain Scale (NPS),Treatment Expectancy Scale (TES), Quantitative Sensory Testing (QST), Insomnia Severity Index (ISI), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI)
Procedure: Sham Acupuncture
Subjects in this group will receive the sham acupuncture procedure on the same schedule as subjects in the real acupuncture group. In both groups, patients' eyes will be covered with patches so they cannot observe the treatment procedure. To improve incentive to join and stay in the study, we will unblind all patients at Week 12, and offer those randomized to the Sham group 8 weeks of Acu (real) treatment. All points used will be documented.
Active Comparator: Usual Care Group
Twelve weeks of usual care.
Behavioral: questionnaires
FACT/GOG-Ntx, Neuropathic Pain Scale (NPS),Treatment Expectancy Scale (TES), Quantitative Sensory Testing (QST), Insomnia Severity Index (ISI), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI)
Other: Usual Care Group
Patients go to clinic three times during the study, at Baseline, Week 8, and Week 12 to undergo QST and CPM tests. Patients will complete all questionnaires (CIPN severity by 0-10 11-point numeric rating scale, FACT/GOG-Ntx-11, NPS) and their pain medication use at these time points. Week 4 questionnaires can be completed over the phone. As an incentive for patients to join the study - and for those randomized to control to stay in the study - controls will be offered 8 weeks of Acu (real) treatment once they have completed Week 12 assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the proportion of patients with a CIPN severity
Time Frame: up to 12 weeks
according to the NCI-CTC 4.0
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Ting Bao, MD, DABMA, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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