ClinicalTrialsFinder
RecruitingNot ApplicableNCT04805528

Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck

Prospective Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck

Sponsor

University of Rochester

Enrollment

75 participants

Start Date

Mar 10, 2022

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer

Summary

The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Age \> 18 years
  • No restrictions on gender or ethnicity
  • Ability and willingness to present for ALTENS therapy over 12 weeks
  • Previous radiation to the head and neck with a dose \> 50 Gy
  • Subjective complaint of dry mouth
  • No evidence of active malignancy in the head and neck region
  • Minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site

Exclusion Criteria12

  • Age under 18 years of age
  • Inability to present for ALTENS therapy
  • Inability to fill out quality of life questionnaires
  • Ability and desire to receive concurrent chemoradiation therapy
  • Because ALTENs may stimulate nerves similar to those of pilocarpine, the following exclusions are noted as theoretically ALTENS could produce worse symptoms
  • Unstable Angina
  • Unstable cardiac disease with hospitalization in the last 6 months
  • Presence of a pacemaker, ICD, or other electronic implanted device that could be affected
  • Myocardial infarction in the last 6 months
  • Symptomatic arrhythmia in the last 6 months
  • Severe COPD with exacerbation causing hospitalization within the last 6 months
  • Pregnancy or the possibility of pregnancy

Interventions

RADIATIONAcupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)

Twice weekly ALTENS therapy for 12 weeks

Locations(1)

University of Rochester

Rochester, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04805528

Related Trials

Effect of Physical Activity Program on Sedentary of Patients With Upper Aerodigestive Tract Cancer

NCT061848801 location

Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology

NCT025071415 locations

Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

NCT038757161 location

Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life

NCT066674271 location

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT0458575076 locations