Clinical trial NCT04917796: The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Official title: A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Nerve Pain
Neuropathy
Neuropathy, Painful
Pain
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Keywords: Chemotherapy-induced Peripheral Neuropathy
CIPN
Electroacupuncture
Cancer survivor
Acupuncture
Memorial Sloan Kettering Cancer Center
Neuropathy
Dana-Farber Cancer Institute
Neuropathic Pain
Pain Management
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2021-06-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: During the study, patients will be randomized to one of the two possible acupuncture treatment groups and receive 10 treatments over the course of 8 weeks and then enter a follow-up period. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.

Eligibility criteria: 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

Primary outcomes:
measure: Difference of pain severity from baseline to 4 weeks after baseline.
timeFrame: 4 weeks
measure: Difference of pain severity from baseline to 8 weeks after baseline.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited protocol activities)
state: New York
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ting Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: