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Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women

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ClinicalTrials.gov Identifier: NCT04067544
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa J Taylor-Swanson, University of Utah

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Breast Cancer Female Gynecologic Cancer Device: Acupuncture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast or Gynecologic Cancers: Mechanisms of Action and Feasibility
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Acupuncture Treatment
All patients receive 10 acupuncture treatments over the course of 8 weeks.
Device: Acupuncture

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.





Primary Outcome Measures :
  1. Mean monthly enrollment [ Time Frame: 18 Months ]
    Average of 2 eligible women per month to participate in the trial

  2. Retention Rate [ Time Frame: 2 Months ]
    70% or more participants comply with AT attendance defined as 8 or more of 10 AT sessions and complete both fMRI scans

  3. Number of Serious Adverse Events [ Time Frame: 2 Months ]
    Zero serious adverse events directly related to AT sessions

  4. Questionnaire Completion Rate [ Time Frame: 4 Months ]
    70% or more enrolled participants comply with data collection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Female age 18 or older.

  • Histologically proven breast, uterine, cervical or ovarian cancer of any stage.
  • Received Paclitaxel treatment dose of at least 480 mg/m2 paclitaxel as a single or combination agent. Paclitaxel treatment must be completed at least 3 months prior to enrollment.
  • Eligible patients 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.
  • ECOG status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, <50% in bed during the day).

Exclusion Criteria:

  • 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.
  • Patients 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067544


Contacts
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Contact: Lisa J Taylor-Swanson, PhD LAc 8015855486 lisa.taylor-swanson@nurs.utah.edu
Contact: Annie Budhathoki, DAOM LAc 801-587-4435 annie.budhathoki@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Lisa Taylor-Swanson, PHD    801-585-5486    lisa.taylor-swanson@nurs.utah.edu   
Contact: Natalie A Rojas, BS    801-213-6231    natalie.rojas@hci.utah.edu   
Principal Investigator: Lisa Taylor-Swanson, PHD LAc         
Sub-Investigator: Annie Budhathoki, DAOM LAc         
Sub-Investigator: Anna Beck, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Lisa J Taylor-Swanson, PhD LAc Associate Professor of College of Nursing, Licensed Acupunturist

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Responsible Party: Lisa J Taylor-Swanson, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04067544     History of Changes
Other Study ID Numbers: 107709
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lisa J Taylor-Swanson, University of Utah:
paclitaxel
chemotherapy-induced peripheral neuropathy
breast cancer
gynecologic cancer
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases