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Acupuncture for Symptoms of Nerve Damage

Primary Purpose

Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Usual Care Group
questionnaires
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Acupuncture, 17-298

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center @ Commack
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Acupuncture Treatment Group

Sham Acupuncture Treatment Group

Usual Care Group

Arm Description

Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.

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.

Twelve weeks of usual care.

Outcomes

Primary Outcome Measures

change in the proportion of patients with a CIPN severity
according to the NCI-CTC 4.0

Secondary Outcome Measures

Full Information

First Posted
June 8, 2017
Last Updated
July 20, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03183037
Brief Title
Acupuncture for Symptoms of Nerve Damage
Official Title
Acupuncture for Persistent Chemotherapy-induced Peripheral Neuropathy Symptoms in Solid Tumor Survivors: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (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
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy
Keywords
Acupuncture, 17-298

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three - arm pilot randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Treatment Group
Arm Type
Experimental
Arm Description
Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.
Arm Title
Sham Acupuncture Treatment Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
Twelve weeks of usual care.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Description
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)
Primary Outcome Measure Information:
Title
change in the proportion of patients with a CIPN severity
Description
according to the NCI-CTC 4.0
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Bao, MD, DABMA, MS
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31456070
Citation
Zhi WI, Chen P, Kwon A, Chen C, Harte SE, Piulson L, Li S, Patil S, Mao JJ, Bao T. Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing. Breast Cancer Res Treat. 2019 Dec;178(3):587-595. doi: 10.1007/s10549-019-05416-4. Epub 2019 Aug 27.
Results Reference
derived
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Acupuncture for Symptoms of Nerve Damage

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