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Head-Neck

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

Unique Data Set IDnci-data-17
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNCITotal Study Enrolled Patients148RandomizationYesPubMed (PMID)25841622.00ClinicalTrial.gov IDNCT00656513ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00656513
Study PhaseClinical Study Phase IIB, Clinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, SurgeryData Set TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary Determine the feasibility of successfully delivering acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) using the Codetron? unit in a cooperative group setting in head and neck cancer patients with early radiotherapy-induced xerostomia. (phase II) Compare the efficacy of ALTENS treatment vs pilocarpine hydrochloride in these patients in reducing overall xerostomia burden, as measured by the University of Michigan 15-item Xerostomia-Related Quality of Life Scale (XeQOLS) at 9 months after randomization. (phase III) Secondary Evaluate the effect of ALTENS treatment on overall xerostomia burden at 6 months after study entry in these patients. (phase II) Compare the efficacy of these treatments in these patients in reducing overall xerostomia burden at 4, 6, and 15 months after randomization. (phase III) Compare the efficacy of these treatments in these patients in reducing symptom burden, as measured by the four domains of the XeQOLS (i.e., physical functioning, social functioning, personal/psychological functioning, and pain/discomfort) at 4, 6, 9, and 15 months after randomization. (phase III) Compare the efficacy of these treatments in these patients in increasing stimulated (i.e., citric acid primed) whole salivary production (WSP), as measured by sialometry, at 4, 6, 9, and 15 months after randomization. (phase III) Compare the efficacy of these treatments in these patients in increasing unstimulated (i.e., basal primed) WSP, as measured by sialometry at 4, 6, 9, and 15 months after randomization. (phase III) Compare adverse events associated with these treatments in these patients. (phase III)

Outcome Measures

Primary: Successful delivery of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment using the Codetron? unit (phase II) [ Time Frame: At the end of the successful delivery of protocol treatment ] Overall xerostomia burden at 9 months after randomization, as measured by the University of Michigan 15-item Xerostomia Related Quality of Life Scale (XeQOLS) (phase III) [ Time Frame: Pre-treatment to 9 months from randomization ] Secondary: Beneficial treatment response, defined as a 20% improvement in overall xerostomia burden (XeQOLS score) from baseline to 6 months after study entry (phase II) [ Time Frame: Pre-treatment to 6 months from registration ] Overall xerostomia burden at 4, 6 and 15 months after randomization as measured by the XeQOLS (phase III) [ Time Frame: Pre-treatment to 4, 6, 9 and 15 months from randomization ] Symptom burden at 4, 6, 9, and 15 months after randomization, as measured by the four domains of the XeQOLS: physical functioning, social functioning, personal/psychological functioning, and pain/discomfort (phase III) [ Time Frame: Pre-treatment to 4, 6, 9 and 15 months from randomization ] Stimulated (i.e., citric acid primed) whole salivary production (WSP), as measured by sialometry at 4, 6, 9, and 15 months after randomization (phase III) [ Time Frame: Pre-treatment to 4, 6, 9 and 15 months from randomization ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00656513-D1-Data-Dictionary.pdf

DATA: NCT00656513-D1-Dataset.csv

OTHER: README.pdf