RTOG-0537

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. W. Wong

Status

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