Acupuncture for Symptoms of Nerve Damage

May 2, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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