Chemotherapy-induced Peripheral Neuropathy, Peripheral Neuropathy
Conditions
Keywords
Acupuncture, 17-298
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.
Interventions
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.
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.
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.
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)
Sponsors
Study design
Intervention model description
Three - arm pilot randomized controlled trial
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the proportion of patients with a CIPN severity | up to 12 weeks | according to the NCI-CTC 4.0 |
Countries
United States