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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408759
First Posted: December 7, 2006
Last Update Posted: December 7, 2006
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.
Information provided by:
Bnai Zion Medical Center
  Purpose

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 Intervention Phase
Xerostomia Behavioral: hypnosis Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • salivaa volume
  • quality of life related to salivation

Estimated Enrollment: 10
Study Start Date: November 2006
Estimated Study Completion Date: December 2006
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.
  Eligibility

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)
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00408759     History of Changes
Other Study ID Numbers: eschiff
First Submitted: December 6, 2006
First Posted: December 7, 2006
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