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Acupuncture for Prevention of Radiation-Induced Xerostomia

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00430378
  Purpose

Primary Objective:

1. Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment to the head and neck area.

Secondary Objectives:

  1. Determine whether acupuncture reduces the severity of xerostomia.
  2. Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment for cancer of the head and/or neck area.

Condition Intervention
Xerostomia
Mouth Dryness
Nasopharyngeal Cancer
Procedure: Acupuncture
Other: Standard Care

MedlinePlus related topics:   Acupuncture    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Acupuncture for Prevention of Radiation-Induced Xerostomia

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

Primary Outcome Measures:
  • Investigate if acupuncture is effective in preventing xerostomia among cancer patients at Fudan University Cancer Hospital (Cancer Hospital) who receive radiation treatment. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether acupuncture reduces the severity of xerostomia. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Determine the feasibility of providing acupuncture treatment to patients at Cancer Hospital who are receiving radiation treatment. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   January 2007
Estimated Primary Completion Date:   January 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Acupuncture Before the Radiation Treatment
Procedure: Acupuncture
Acupuncture for 20 minutes before the radiation therapy session, 3 days a week for 7 weeks.
2: Experimental
Standard Care Without Acupuncture
Other: Standard Care
No Acupuncture.

Show detailed description  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 concurrent chemotherapy and radiation treatment
  3. Treatment plan must include treatment of at least 50 gray 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.

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. Planned IMRT
  3. Suspected or confirmed physical closure of salivary gland ducts on either side
  4. Known bleeding disorders and 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 cholinergic agonist medication (Pilocarpine, Cevimeline), beta adrenergic antagonists, anticholinergic agents or other medications known to affect salivary function
  13. Currently receiving acupuncture for any condition
  14. No prior head and neck radiation treatment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430378

Contacts
Contact: Joseph S. Chiang, MD     713-794-5363    

Locations
China
Fudan University Cancer Hospital     Recruiting
      Shanghai, China

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Joseph S. Chiang, MD     U.T. M.D. Anderson Cancer Center    
  More Information

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Joseph S. Chiang, MD/Professor )
Study ID Numbers:   2006-0763
First Received:   January 30, 2007
Last Updated:   January 8, 2008
ClinicalTrials.gov Identifier:   NCT00430378
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Xerostomia  
Dry Mouth  
Mouth Dryness  
Nasopharyngeal Cancer  
Acupuncture  

Study placed in the following topic categories:
Mouth Diseases
Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Diseases
Salivary Gland Diseases
Nasopharyngeal Neoplasms
Xerostomia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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