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The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Nerve Pain

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Electroacupuncture
Sham Acupuncture
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Chemotherapy-induced Peripheral Neuropathy, CIPN, Electroacupuncture, Nerve pain, Cancer survivor, 20-246, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English-proficient men and women aged ≥18 years
  • Free of oncologic disease by clinical examination and history
  • Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment
  • Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia73
  • Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week
  • On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications
  • Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period
  • Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments

Exclusion Criteria:

  • Patients with a pacemaker or other electronically charged medical device
  • Use of acupuncture for symptom management within the past 12 months

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan - Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Nassau (Limited protocol activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Electroacupuncture Arm

Sham Acupuncture Arm

Arm Description

The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.

The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.

Outcomes

Primary Outcome Measures

Difference of pain severity from baseline to 4 weeks after baseline.
The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form (BPI-SF)
Difference of pain severity from baseline to 8 weeks after baseline.
The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form

Secondary Outcome Measures

Full Information

First Posted
June 2, 2021
Last Updated
October 16, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04917796
Brief Title
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Official Title
A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 21, 2025 (Anticipated)
Study Completion Date
May 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
Electroacupuncture (referred to as EA) may be an effective treatment for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Nerve Pain
Keywords
Chemotherapy-induced Peripheral Neuropathy, CIPN, Electroacupuncture, Nerve pain, Cancer survivor, 20-246, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Randomization will occur before the baseline assessments are administered. Once the patient is randomized, the acupuncturists will look up the patient's group assignment and provide the appropriate treatment. The study team and patients will be blinded to which acupuncture group the patient was assigned. The acupuncturists and one clinical research coordinator will be the only ones unblinded. The clinical research coordinator will be unblinded in order to assist acupuncturists to confirm randomization. This clinical research coordinator will not be the primary research coordinator in the study and will not have direct contact with the patient. The rest of the study coinvestigators and staff will remain blinded.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture Arm
Arm Type
Experimental
Arm Description
The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.
Arm Title
Sham Acupuncture Arm
Arm Type
Placebo Comparator
Arm Description
The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA
Intervention Description
Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).
Intervention Type
Device
Intervention Name(s)
Sham Acupuncture
Intervention Description
Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).
Primary Outcome Measure Information:
Title
Difference of pain severity from baseline to 4 weeks after baseline.
Description
The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form (BPI-SF)
Time Frame
4 weeks
Title
Difference of pain severity from baseline to 8 weeks after baseline.
Description
The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-proficient men and women aged ≥18 years Free of oncologic disease by clinical examination and history Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia73 Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week On a stable regimen (no change in the past three months) if taking anti-neuropathy or other pain medications Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments Exclusion Criteria: Patients with a pacemaker or other electronically charged medical device Use of acupuncture for symptom management within the past 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Email
maoj@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Wanqing Zhi, MD, PhD
Phone
631-623-4246
Email
zhiw@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Monmouth (Limited protocol activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Nassau (Limited protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

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