Trial record 9 of 248 for:    xerostomia

Xerostomia Pilot Fudan: Acupuncture for Prevention of Radiation-Induced Xerostomia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00862550
First received: March 16, 2009
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

PRIMARY AIM

  1. Determine the feasibility of providing true and sham acupuncture treatment to patients at Fudan University Cancer Hospital (Cancer Hospital) who are receiving radiation treatment for cancer of the head and/or neck area.

    SECONDARY AIMS

  2. Determine if true acupuncture is more effective than sham acupuncture for preventing radiation-induced xerostomia among cancer patients at Cancer Hospital.
  3. Determine if true acupuncture is more effective than sham acupuncture for reducing the severity of radiation-induced xerostomia.

Condition Intervention
Head and Neck Cancer
Xerostomia
Other: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Subject Recruitment (#) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Feasibility determined by how many eligible patients approached consented to be in the trial and patients' reported satisfaction with the study


Estimated Enrollment: 23
Study Start Date: March 2009
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Acupuncture (Areas known to help dry mouth)
Other: Acupuncture
20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.
Experimental: Group 2
Acupuncture (Areas not known to help dry mouth)
Other: Acupuncture
20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1) Adult >/= 18 year of age and able to sign informed consent

2) Diagnosed with nasopharyngeal carcinoma and scheduled to undergo IMRT

3) Treatment plan must include treatment at a mean dose of 25 gray or more bilateral to the parotid

4) Must have anatomically intact parotid and submandibular glands

5) Karnofsky Performance Status > 60

6) If the participant is female and of child bearing potential, must have a negative urine pregnancy test. (Acupuncture should be used cautiously during pregnancy since some points have been shown to stimulate uterine contractions

Exclusion Criteria:

  1. History of xerostomia prior to the head and neck radiation therapy (Sjögren's disease or other underlying systemic illness known to cause xerostomia).
  2. Prior head and neck radiation treatment
  3. Suspected or confirmed physical closure of salivary gland ducts on either side
  4. Known bleeding disorders or on Heparin or Coumadin
  5. Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory
  6. Local skin infections at or near the acupuncture site or active systemic infection
  7. History of cerebrovascular accident or spinal cord injury. (The mechanism of action for acupuncture may be associated with central nervous system (CNS) activity, and patients with CNS pathology may respond differently to treatment than the general population.)
  8. Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process
  9. Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria
  10. Participants who are taking or who have taken any investigational new drug within the last 30 days, or who are planning to take such a drug during the course of the study
  11. Current acknowledged use of other alternative medicines such as herbal preparations that could affect salivary function. Each patient will be asked for a list of herbal supplements they are currently taking and this will be reviewed on an individual basis. Patients will be excluded if they are taking any herbs known or suspected to affect salivary function
  12. Participants taking amifostine, cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents, saliva substitutes or other medications known to affect salivary function
  13. Currently receiving acupuncture for any condition
  14. Prior use of acupuncture
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862550

Locations
China
Fudan University Cancer Hospital
Shanghai, China
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Joseph S. Chiang, MD, MS, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00862550     History of Changes
Other Study ID Numbers: 2008-0801, NCI-2009-01558
Study First Received: March 16, 2009
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
HNC
Nasopharyngeal carcinoma
Acupuncture
Radiation-Induced Xerostomia
Xerostomia
Dry Mouth
Radiation

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 19, 2014