Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women
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|ClinicalTrials.gov Identifier: NCT04067544|
Recruitment Status : Terminated (Unforeseen complications due to COVID-19 and funding)
First Posted : August 26, 2019
Last Update Posted : August 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Peripheral Neuropathy Breast Cancer Female Gynecologic Cancer||Device: Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 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|
|Actual Study Start Date :||November 5, 2019|
|Actual Primary Completion Date :||August 12, 2020|
|Actual Study Completion Date :||August 12, 2020|
All patients receive 10 acupuncture treatments over the course of 8 weeks.
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.
- Mean monthly enrollment [ Time Frame: 18 Months ]Average of 2 eligible women per month to participate in the trial
- 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
- Number of Serious Adverse Events [ Time Frame: 2 Months ]Zero serious adverse events directly related to AT sessions
- Questionnaire Completion Rate [ Time Frame: 4 Months ]70% or more enrolled participants comply with data collection
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
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Lisa J Taylor-Swanson, PhD LAc||Associate Professor of College of Nursing, Licensed Acupunturist|