Acupuncture for Symptoms of Nerve Damage

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 7, 2017

Primary Completion Date

May 2, 2024

Study Completion Date

May 2, 2024

Conditions
Peripheral NeuropathyChemotherapy-induced Peripheral Neuropathy
Interventions
PROCEDURE

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.

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.

OTHER

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.

BEHAVIORAL

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)

Trial Locations (2)

10065

Memorial Sloan Kettering Cancer Center, New York

11725

Memorial Sloan Kettering Cancer Center @ Commack, Commack

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03183037 - Acupuncture for Symptoms of Nerve Damage | Biotech Hunter | Biotech Hunter