Acupuncture for Symptoms of Nerve Damage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-07

Study Completion Date

2024-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Neuropathy Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three - arm pilot randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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.

questionnaires

Intervention Type BEHAVIORAL

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)

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.

Group Type PLACEBO_COMPARATOR

Sham Acupuncture

Intervention Type PROCEDURE

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.

questionnaires

Intervention Type BEHAVIORAL

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)

Usual Care Group

Twelve weeks of usual care.

Group Type ACTIVE_COMPARATOR

Usual Care Group

Intervention Type OTHER

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.

questionnaires

Intervention Type BEHAVIORAL

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)

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)