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Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT00408759
Recruitment Status : Unknown
Verified December 2006 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : December 7, 2006
Last Update Posted : December 7, 2006
Sponsor:
Information provided by:
Bnai Zion Medical Center

Brief Summary:

xerostomia develops in all patients with head and neck cancer following radiotherapy. it consists one of the main side effects which affects quality of life. currently, there is no standard of care for treating this condition. parasympathomimetic drugs may help but carry significant side effects.

hypnosis may affect autonomic function such as salivation, in healthy people.in this study we will explore the efficacy of hypnosis in improving salivation, in the patient population.


Condition or disease Intervention/treatment Phase
Xerostomia Behavioral: hypnosis Phase 2

Detailed Description:
10 head and neck cancer patients with xerostomia following radiotherapy will be assessed for severity of xerostomia using questionnares and quantitative salivation tests. patients responsive to citric acid will receive a hypnotic session with specific suggestion for salivation. saliva volume will be assessed pre and post hypnosis. patients will receive a CD with recorded hypnotic session to use freely at home. xerostomia will be assessed using a questionnare one week following hypnosis.

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Study Start Date : November 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources




Primary Outcome Measures :
  1. salivaa volume
  2. quality of life related to salivation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • radiotherapy for head and neck cancer
  • xerostomia

Exclusion Criteria:

  • psychiatric illness (present or past)

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): NCT00408759


Contacts
Contact: elad schiff 972482654767 eschiff@email.arizona.edu
Contact: gorge mogilner 97248359359 eschiff@bezeqint.net

Locations
Israel
bnai zion MC Recruiting
Haifa, Israel
Contact: elad schiff    97248359767    eschiff@email.arizona.edu   
Sub-Investigator: Gorge Mogilner         
Sub-Investigator: Noam Yarom         
Sub-Investigator: Ilana Dowek         
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Elad Schiff Bnai Zion MC

ClinicalTrials.gov Identifier: NCT00408759     History of Changes
Other Study ID Numbers: eschiff
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: December 7, 2006
Last Verified: December 2006

Keywords provided by Bnai Zion Medical Center:
xerostomia
hypnosis
dry mouth
radiotherapy
head and neck cancer

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