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

Who is this study for? Patients with Chemotherapy-Induced Peripheral Neuropathy, Nerve Pain
What treatments are being studied? Electroacupuncture
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan - Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited protocol activities)
RECRUITING
Rockville Centre
Contact Information
Primary
Ting Bao, MD
ting_bao@dfci.harvard.edu
857-215-2844
Backup
Natalie Viyaran
natalie_viyaran@dfci.harvard.edu
617-582-8629
Time Frame
Start Date: 2021-05-21
Estimated Completion Date: 2026-04-24
Participants
Target number of participants: 250
Treatments
Experimental: Electroacupuncture Arm
The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.
Placebo_comparator: Sham Acupuncture Arm
The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.
Authors
Sponsors
Collaborators: Memorial Sloan Kettering Cancer Center
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov