Acupuncture for Symptoms of Nerve Damage

Study Overview
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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.

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

Conditions
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Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Sham Acupuncture
* Other: Usual Care Group
* Behavioral: questionnaires


Participation Criteria
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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) Exclusion Criteria: Patients with a pacemaker Prior acupuncture treatment within 5 years of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three - arm pilot randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture Treatment Group<br>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<br>* 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.<br>Behavioral: questionnaires<br>* 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)<br>|
| Placebo Comparator: Sham Acupuncture Treatment Group<br>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. | Procedure: Sham Acupuncture<br>* 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.<br>Behavioral: questionnaires<br>* 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)<br>|
| Active Comparator: Usual Care Group<br>Twelve weeks of usual care. | Other: Usual Care Group<br>* 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.<br>Behavioral: questionnaires<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, 17-298