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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00656513 |
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.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Head and Neck Cancer |
Drug: pilocarpine hydrochloride Procedure: acupuncture-like transcutaneous electrical nerve stimulation |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized |
Official Title: | A Phase II/III Study Comparing Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia |
Estimated Enrollment: | 189 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase III, arm I: Active Comparator
Patients receive oral pilocarpine three times daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: pilocarpine hydrochloride
Given by mouth 3 times a day for up to 12 weeks
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Phase III, arm II: Experimental
Patients undergo ALTENS treatment using the Codetron™ unit twice weekly for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
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Procedure: acupuncture-like transcutaneous electrical nerve stimulation
Given twice a week for up to 12 weeks
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase II followed by a phase III multicenter study.
Phase III:Patients are stratified according to prior use of pilocarpine (no vs yes) and length of time from completion of chemotherapy and/or radiotherapy (3-6 months vs 6-12 months vs > 12 months). Patients are randomized to 1 of 2 treatment arms.
Patients undergo quality of life (QOL) assessment at baseline and at 6 months after registration in phase II. In phase III patients complete assessments for whole salivary production, xerostomia burden, and QOL at baseline and at 4, 6, 9, and 15 months after study entry.
After completion of study therapy, patients are followed at 3 months.
PROJECTED ACCRUAL: A total of 45 patients will be accrued to the phase II portion and 144 patients to the phase III portion of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of head and neck cancer
Completed radiotherapy (i.e., standard or intensity-modulated radiotherapy) with or without chemotherapy at least 3 months prior to study entry
PATIENT CHARACTERISTICS:
No severe, active co-morbidity, including any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000592644, RTOG-0537 |
Study First Received: | April 10, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00656513 |
Health Authority: | Unspecified |
hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer paranasal sinus and nasal cavity cancer |
oropharyngeal cancer salivary gland cancer metastatic squamous neck cancer with occult primary xerostomia |
Nasopharyngeal carcinoma Metastatic squamous neck cancer with occult primary Oral cancer Head and Neck Neoplasms Laryngeal carcinoma Pilocarpine |
Hypopharyngeal cancer Laryngeal Neoplasms Lip and oral cavity cancer Salivary Gland Diseases Xerostomia |
Neurotransmitter Agents Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Autonomic Agents |
Miotics Physiological Effects of Drugs Muscarinic Agonists Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |