NCT04067544

Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women

Terminated NA Results posted Last updated 6 April 2025

What this trial tests

NA trial testing Acupuncture in Chemotherapy-induced Peripheral Neuropathy in 3 participants. Terminated before completion.

Timeline

5 November 2019

Primary endpoint
12 August 2020

12 August 2020

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	3
Start date	5 November 2019
Primary completion	12 August 2020
Estimated completion	12 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Acupuncture — full drug profile →

Conditions studied

• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →
• Breast Cancer Female — all drugs for Breast Cancer Female →
• Gynecologic Cancer — all drugs for Gynecologic Cancer →

Sponsor

University of Utah

Who can join

18 and older, female only, with Chemotherapy-induced Peripheral Neuropathy or Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Monthly Enrollment Primary · 7 Months

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

Group	Value	95% CI
Acupuncture Treatment	0.429	± 0.787

Number of Participants Compliant With Treatment Primary · 7 Months

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

Group	Value	95% CI
Acupuncture Treatment	2

Number of Participants Who Experience Serious Adverse Events Related to AT Sessions Primary · 7 Months

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.

Group	Value	95% CI
Acupuncture Treatment	0

Number of Participants Who Completed Questionnaires Primary · 7 Months

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

Group	Value	95% CI
Acupuncture Treatment	2

Change in Functional Connectivity of Central Pain Networks on fMRI (Z-scores) Secondary · 9 weeks

Connectivity changes were evaluated using resting-state fMRI at baseline and post-treatment. Independent component analysis was used to identify networks, and statistical thresholds were applied to define significant changes. Z-scores represent standard deviations from the mean of a normative reference population, with positive values indicating increased connectivity and negative values indicating decreased connectivity.

Group	Value	95% CI
Acupuncture Treatment	3.32	± 0.59

Change in Participant-reported Symptoms From Before AT to After Study Completion Secondary · 22 weeks

Quality of Life Questionnaire (QLQ) - Chemotherapy Induced Peripheral Neuropathy (CIPN) 20 (QLQ-CIPN-20) questionnaire is administered to participants at baseline (BL) and at 3 months post-treatment (approximately 22 weeks total between time points). Mean difference between BL and 3 Month Questionnaire scores will be calculated. Only participants who have completed all questionnaires will be evaluated. The 20-item questionnaire is scored using a four-point Likert-type scale ranging from 1 (not at all) to 4 (very much), and evaluates sensory (9 items), motor (8 items), and autonomic (3 items fo

Group	Value	95% CI
Acupuncture Treatment	-25.17	± 5.156

Participant Reported Symptoms 3 Months Post Treatment Secondary · 22 weeks

Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (QLQ-CIPN-20) questionnaire is administered to participants at baseline (BL) and at 3 months post-treatment (approximately 22 weeks total between time points). This outcome reports mean participant scores at 3 months post treatment. Only participants who have completed all questionnaires will be evaluated. The 20-item questionnaire is scored using a four-point Likert-type scale ranging from 1 (not at all) to 4 (very much), and evaluates sensory (9 items), motor (8 items), and autonomic (3 items for men, 2 items for wom

Group	Value	95% CI
Acupuncture Treatment	48.96	± 20.624

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of acupuncture treatment (AT) to 12 weeks following discontinuation of AT (approximately 22 weeks per patient). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acupuncture Treatment

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (2 terms — click to expand)

Reaction	System	Acupuncture Treatment
localized edema	General disorders	—
Nausea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04067544 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging Approaches for the Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Therapeutic Potential of the C5a/C5aR Axis.
   Spera MC, Cesta MC, Zippoli M, Varrassi G, et al · · 2022 · cited 10× · PMID 36098939 · DOI 10.1007/s40122-022-00431-8