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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02474095
Other study ID # I 247213
Secondary ID NCI-2015-00823I
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2014
Est. completion date October 12, 2019

Study information

Verified date July 2022
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized pilot clinical trial studies alternate schedules for acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia) caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a procedure in which mild electric currents are applied to certain acupuncture points on the body and may help relieve dry mouth caused by RT and improve quality of life. It is not yet known whether giving ALTENS more frequently works better than standard ALTENS in treating dry mouth caused by RT.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality-of-Life Assessment
Ancillary studies
Procedure:
Transcutaneous Acupoint Electrical Stimulation
Undergo ALTENS

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in XeQoLS A repeated measures model will be used to compare XeQoLS scores between the two arms at 15 months. Additional analysis will be performed using an area-under-the-curve (AUC) comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two groups over time. Baseline to 15 months
Secondary Change in the quality of life using the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 A repeated measures model will be used to compare EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two arms. Additional analysis will be performed using an AUC comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two groups over time. Baseline to up to 21 months
Secondary Change in XeQoLS A repeated measures model will be used to compare XeQoLS scores between the two arms. Additional analysis will be performed using an AUC comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two groups over time. Baseline to up to 21 months
Secondary Incidence of adverse events between treatment schedules using CTEP NCI CTCAE version 4.0 The frequency of toxicities will be tabulated by grade. Up to 30 days after the last intervention or a new treatment is started
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