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Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia

NCT02292368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-01

No results posted yet for this study

Summary

The goal of this clinical research study is to learn which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve patient quality of life.

Conditions

Interventions

BEHAVIORAL

Questionnaires

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

PROCEDURE

Acupuncture

Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

PROCEDURE

Electroencephalogram (EEG)

Participants have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lorenzo Cohen, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-10
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02292368 on ClinicalTrials.gov