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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Bnai Zion Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00408759
First received: December 6, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • radiotherapy for head and neck cancer
  • xerostomia

Exclusion Criteria:

  • psychiatric illness (present or past)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00408759     History of Changes
Other Study ID Numbers: eschiff
Study First Received: December 6, 2006
Last Updated: December 6, 2006
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013