Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women

NCT04067544 | Terminated Results DMC FDA Device

• 1 other identifier: 107709
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to evaluate the feasibility to conduct a study of acupuncture treatment (AT) for Chemotherapy-Induced Peripheral Neuropathy (CIPN) at Huntsman Cancer Institute and to investigate changes in physiological biomarkers when using acupuncture to treat CIPN.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Breast Cancer Female; Gynecologic Cancer

Keywords

paclitaxel; chemotherapy-induced peripheral neuropathy; breast cancer; gynecologic cancer

Outcome Measures

Primary Outcomes (4)

• Mean Monthly Enrollment

  We calculated the mean number of participants who enrolled per month while the study was open to accrual.

  7 Months

• Number of Participants Compliant With Treatment

  Participant retention was defined as the number of participants who attended at least 8 out of 10 AT sessions and completed both fMRI scans

  7 Months

• Number of Participants Who Experience Serious Adverse Events Related to AT Sessions

  A serious adverse event is any undesirable experience associated with the participation in this study in a participant that results in death, life-threatening conditions, hospitalization, disability or permanent damage or birth defect.

  7 Months

• Number of Participants Who Completed Questionnaires

  Participants who completed all questionnaires, which were administered at baseline and at 3 months post-treatment.

  7 Months

Secondary Outcomes (2)

• Change in Functional Connectivity of Central Pain Networks on fMRI (Z-scores)

  9 weeks

• Change in Participant-reported Symptoms From Before AT to After Study Completion

  22 weeks

Other Outcomes (1)

• Participant Reported Symptoms 3 Months Post Treatment

  22 weeks

Study Arms (1)

Acupuncture Treatment

EXPERIMENTAL

All participants receive 10 acupuncture treatments over the course of 8 weeks.

Device: Acupuncture

Interventions

Acupuncture DEVICE

The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders. Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.

Acupuncture Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female age 18 or older.
• Histologically proven breast, uterine, cervical or ovarian cancer of any stage.
• Received either (1) a Paclitaxel treatment dose of at least 480 mg/m2 paclitaxel as a single or combination agent or (2) a Docetaxel treatment dose of at least 150 mg/m2 docetaxel as a single or combination agent. Treatment must be completed at least 3 months prior to enrollment.
• Eligible participants report at least 1 month of altered sensation and/or pain in the feet (with or without presence in one or both hands) with a score of greater than or equal to 20 for CIPN on the sensory subscale of the CIPN-20 (scale 0-100).
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
• Eastern Cooperative Oncology Group (ECOG) status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, \<50% in bed during the day).

You may not qualify if:

• Preexisting neuropathy due to other identified etiologies includes diabetes, vitamin B12 deficiency, or alcoholism.
• Having received more than 6 acupuncture treatments for any condition in the last six months.
• Participants with claustrophobia, pacemakers, non-MRI compatible breast expanders or port-a-caths, neurostimulator devices, current pregnancy, exposure to shrapnel, left-handedness, or otherwise unsafe for MRI scanning.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

The COVID-19 pandemic forced recruitment and enrollment to stop in March 2020 leading to small numbers of participants analyzed.

Results Point of Contact

• Title: Lisa Taylor-Swanson
• Organization: University of Utah College of Nursing

lisa.taylor-swanson@nurs.utah.edu

801.585.5486

Study Officials

• Lisa J Taylor-Swanson, PhD LAc

  Associate Professor of College of Nursing, Licensed Acupunturist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: November 5, 2019
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)