A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia
Principal Investigator
Raimond K. Wong, MD
Status
Terminated
Date Opened To Accrual
September 19 2008
Date Closed to Accrual
December 05 2011
Date of Study Termination
November 17 2014
Disease Site
Head and Neck [HN]
Head and Neck
Phase
II/III
Developmental Therapeutics
No
Primary Objective
Phase II component-Determine the feasibility of successfully delivering the ALTENS treatment (given with the Codetron® unit) in a cooperative group setting
Phase III component-Determine whether the ALTENS treatment reduces overall xerostomia burden, as measured by the University of Michigan 15-item Xerostomia-Related Quality of Life Scale (XeQOLS), compared to the pilocarpine treatment at 9 months from randomization
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Patient Population
Patients who have completed radiotherapy (standard or IMRT) +/- chemotherapy for head and neck cancers and who have grade 1-2 xerostomia according to the CTCAE v. 3.0 dry mouth/salivary gland xerostomia scale
Target Accrual
189
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.