A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)

ENROLLING
Protocol # :
23-510
Conditions
Chemotherapy-induced Peripheral Neuropathy
Nerve Pain
Neuropathy
Neuropathy, Painful
Phase
III
Disease Sites
Other specified personal risk factors, not elsewhere classified
Principal Investigator
Bao, Ting

Trial Description

This study is a randomized controlled trial of electroacupuncture (referred to as EA)
versus sham acupuncture (referred to as EA) as effective treatments for
Chemotherapy-Induced Peripheral Neuropathy/CIPN pain in cancer survivors.

Eligibility Requirements

Inclusion Criteria:

- English-proficient men and women aged ≥18 years

- Free of oncologic disease by clinical examination and history

- Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids,
and bortezomib at least three months prior to enrollment

- Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the
presence of symmetrical stocking-glove pain, numbness, or paresthesia73

- Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse
Events (CTCAE) version 5.0

- Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on
the BPI-SF average pain item over the past week

- On a stable regimen (no change in the past three months) if taking anti-neuropathy
or other pain medications

- Willing to adhere to requirement that no new pain medication be taken throughout the
first 12 weeks of the study period

- Willing to adhere to all study-related procedures, including randomization to one of
the two possible acupuncture treatments

Exclusion Criteria:

- Patients with a pacemaker or other electronically charged medical device

- Use of acupuncture for symptom management within the past 12 months

23-510