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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00862550
Recruitment Status : Active, not recruiting
First Posted : March 17, 2009
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE March 16, 2009
First Posted Date  ICMJE March 17, 2009
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE March 2009
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2009)
Learn if acupuncture is effective in preventing xerostomia (dry mouth) in cancer patients who receive radiation treatment to the head and neck area. [ Time Frame: 2 Years ]
Change History Complete list of historical versions of study NCT00862550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Xerostomia Pilot Fudan: Acupuncture for Prevention of Radiation-Induced Xerostomia
Official Title  ICMJE Randomized Pilot Trial of Acupuncture for Prevention of Radiation-Induced Xerostomia
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.
Detailed Description

Acupuncture is the use of very thin needles that are stuck in your skin at certain areas of the body, acupuncture is believed to affect bodily function.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

  • Your complete medical history will be recorded.
  • You will have a physical exam.
  • You will complete 3 short questionnaires about your quality-of-life and current saliva flow. It will take about 5 minutes to complete all the questionnaires.
  • Two (2) saliva samples will be collected. To collect the first saliva sample, you will collect saliva in a vial (small tube or jar) for 5 minutes, by allowing saliva to collect in your mouth and then spitting it into the vial. You will wait 5 minutes and then hold a sour liquid in your mouth for 1 minute. Then a second saliva sample will be collected.
  • A traditional Chinese medicine diagnosis will be performed. During this diagnosis, your pulse will be checked and photographs of your tongue will be taken. You will not be able to be identified by the photos. The photos will be destroyed when the study is complete. This will allow a more objective check of your tongue condition.
  • Women who are able to become pregnant must have a negative urine pregnancy test.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in the study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. Both groups will have acupuncture sessions for 20 minutes before radiation therapy treatments.

  • If you are in Group 1, you will have the needles stuck in areas that are known to help dry mouth.
  • If you are in Group 2, you will have the needles stuck in areas that are not known to help dry mouth.

When the study is over, participants in Group 2 will be offered 1 week of acupuncture (3 treatments) in the areas known to help dry mouth.

Acupuncture:

All acupuncture sessions will be done before your radiation therapy 3 days a week for 7 weeks. The acupuncturist will put in the needles in certain areas of your body (including your chin, wrist, leg, and ear) while you are lying on a bed. The needles will remain in your body for about 20 minutes.

Study Visits:

Both groups will have the following tests and procedures performed before each acupuncture treatment, once a week:

  • Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured.
  • You will be asked about any drugs you may be taking.
  • You will complete the same questionnaires that you filled out during the screening tests.

Saliva samples will be collected on Weeks 1, 3, 4, 6, and 7. The samples will be collected the same way as done in screening. The samples will be collected after the acupuncture sessions on Weeks 1, 4, and before the acupuncture on Weeks 3 and 6.

You will have the Chinese medicine diagnosis on Weeks 3 and 7.

Length of Study:

You will be on study for 11 weeks. You will be taken off study if the condition gets worse or if intolerable side effects occur. You will be taken off study if you take any drugs for dry mouth.

End-of-Study Visit:

You will have an end-of-study visit 1 month after your last radiation treatment (Week 11). The following tests and procedures will be performed:

  • Your vital signs will be measured.
  • You will be asked about any drugs you may be taking.
  • You will complete the quality-of-life and saliva flow questionnaires.
  • You will have the 2 saliva samples a saliva sample will be collected.
  • You will have the Chinese medicine diagnosis.

This is an investigational study. Up to 23 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Head and Neck Cancer
  • Xerostomia
Intervention  ICMJE Other: Acupuncture
20 Minute Acupuncture Sessions Before Radiation Therapy Treatment, 3 Days Per Week for 7 Weeks.
Study Arms  ICMJE
  • Experimental: Group 1
    Acupuncture (Areas known to help dry mouth)
    Intervention: Other: Acupuncture
  • Experimental: Group 2
    Acupuncture (Areas not known to help dry mouth)
    Intervention: Other: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2010)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2009)
20
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862550
Other Study ID Numbers  ICMJE 2008-0801
NCI-2009-01558 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph S. Chiang, MD, MS, BS M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP