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

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ClinicalTrials.gov Identifier: NCT00862550
Recruitment Status : Recruiting
First Posted : March 17, 2009
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Head and Neck Cancer Xerostomia Other: Acupuncture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia
Actual Study Start Date : March 2009
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Subject Recruitment (#) [ Time Frame: 2 Years ]
    Feasibility determined by how many eligible patients approached consented to be in the trial and patients' reported satisfaction with the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862550


Contacts
Contact: Joseph S. Chiang, MD, MS, BS 713-795-4260

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00862550     History of Changes
Other Study ID Numbers: 2008-0801
NCI-2009-01558 ( Registry Identifier: NCI CTRP )
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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