Clinical Trials Logo
  1. Home
  2. Head and Neck Carcinoma
  3. NCT02474095

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

Xerostomia Clinical Trial

Official title:
Two Versus Four Times-Weekly ALTENS for Treatment of Radiation-Induced Xerostomia: A Pilot Study

Clinical Trial Summary

This randomized pilot clinical trial studies alternate schedules for acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia) caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a procedure in which mild electric currents are applied to certain acupuncture points on the body and may help relieve dry mouth caused by RT and improve quality of life. It is not yet known whether giving ALTENS more frequently works better than standard ALTENS in treating dry mouth caused by RT.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS), compared to the standard ALTENAS schedule of twice-weekly for 12 weeks, at 15 months from the start of ALTENS treatment. SECONDARY OBJECTIVES: I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS), compared to the standard ALTENS schedule of twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment. II. Examine the benefit of ALTENS treatment using a four-times weekly schedule for 6 weeks on overall quality of life, using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire, QLQ-C30, including the questionnaire module specific to head and neck cancers (QLQ-H&N35), compared to the standard ALTENS schedule of twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment. III. To compare the toxicity between treatment schedules using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo ALTENS delivered via the Codetron machine four times weekly (QIW) for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo ALTENS delivered via the Codetron machine twice-weekly (BIW) for 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6, 9, 15, and 21 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02474095
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase N/A
Start date November 4, 2014
Completion date October 12, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT05342272 - Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction Phase 3
Completed NCT03302676 - The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors N/A
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Completed NCT01272570 - Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors N/A
Completed NCT00656513 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00911768 - Effect of Korean Red Ginseng (KRG) on Dry Mouth Phase 4
Completed NCT00332618 - Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia Phase 2
Completed NCT03494985 - A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water N/A
Completed NCT05058430 - SaliPen Human Factors Study for OTC Labeling N/A
Recruiting NCT02705937 - Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications. N/A
Completed NCT05247008 - Effectiveness of Thyme Honey in Management of Xerostomia in ESRD N/A
Recruiting NCT03632096 - Photobiomodulation in Salivary Production of Patients With Xerostomy Phase 2
Not yet recruiting NCT04323384 - The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing N/A
Not yet recruiting NCT03530735 - Finger-prick Autologous Blood (FAB) for Use in Dry Mouth N/A
Active, not recruiting NCT03176368 - Coconut Oil: Managing Radiation-Induced Xerostomia N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
Completed NCT02682199 - Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Withdrawn NCT01960101 - Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication N/A
Completed NCT02317172 - Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases N/A