Acupuncture in Preventing Radiation-Induced Xerostomia

Status: Closed to Accrual

Description

This randomized phase III trial studies two different forms of acupuncture to see how well it works compared to standard care in preventing dry mouth (xerostomia) in patients with head and neck cancer undergoing radiation therapy. Acupuncture may help relieve dry mouth caused by radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent
  • Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo intensity modulated radiation therapy (IMRT) with or without concurrent chemotherapy at M. D. Anderson
  • Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy)
  • Anatomically intact parotid and submandibular glands
  • Karnofsky performance status > 60

Exclusion Criteria

  • History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia
  • Prior head and neck radiation treatment
  • Suspected or confirmed physical closure of salivary gland ducts on either side
  • Known bleeding disorders or taking any dose of warfarin or heparin
  • Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory
  • Local skin infections at or near the acupuncture sites or active systemic infection
  • History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity
  • Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry
  • Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria
  • Current acknowledged use of amifostine trihydrate, cholinergic agonist medications (pilocarpine hydrochloride, cevimeline hydrochloride), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function
  • Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Determine if true acupuncture is more effective than sham acupuncture or standard care for preventing the severity of radiation-induced xerostomia among cancer patients at M. D. Anderson and Fudan Cancer Hospital.

SECONDARY OUTCOMES:

I. Examine group differences in saliva flow using unstimulated and stimulated whole salivary flow rates. This will provide a more objective measure of salivary function.

II. Determine if true acupuncture is more effective than sham acupuncture or standard care for reducing the incidence of radiation-induced xerostomia.

III. Examine whether true acupuncture results in better overall quality of life than sham acupuncture or standard of care.

IV. Determine the effects of acupuncture on saliva-based factors including pH, buffering capacity, and viscosity as well as levels of total protein, calcitonin-gene-related peptide (CGRP), and vasoactive intestinal polypeptide (VIP).

V. Examine the role of expectancy for the benefits of acupuncture in predicting outcomes. The role of expectancy as a moderator of the effects of treatment will be thoroughly examined.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I (acupuncture 1): Patients receive acupuncture at 14 points over 20 minutes up to 3 days a week for 7 weeks.

ARM II (acupuncture 2): Patients receive sham acupuncture at 14 different points over 20 minutes up to 3 days a week for 7 weeks.

ARM III: Patients receive standard care during the radiation treatment period.

After completion of study treatment, patients are followed up at 2-4, 5-9, and 10-15 months.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Supportive care

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Lorenzo Cohen

Trial IDs

Primary ID 2010-0584
Secondary IDs NCI-2011-00306
Clinicaltrials.gov ID NCT01266044