CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
Pilocarpine +1 moredrug
Likely dose
Pilocarpine 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00656513
NCT00656513Phase 3Completed
CompareCT.gov

A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia

Radiation Therapy Oncology Group·interventional·Posted Apr 11, 2008·Updated Nov 19, 2019

In Brief

A Phase 3 clinical trial evaluating Pilocarpine and ALTENS for Head and Neck Cancer and Xerostomia. Completed, enrolled 196 participants across 20 sites in 2 countries.

Detailed Summary

RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Xerostomia
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2008
Enrollment StartSep 1, 2008
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 18.2 years ago

Interventions

Pilocarpinedrug

5mg by mouth 3 times a day for 12 weeks

ALTENSprocedure

Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit