Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Primary Purpose
Xerostomia
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
hypnosis
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia focused on measuring xerostomia, hypnosis, dry mouth, radiotherapy, head and neck cancer
Eligibility Criteria
Inclusion Criteria:
- radiotherapy for head and neck cancer
- xerostomia
Exclusion Criteria:
- psychiatric illness (present or past)
Sites / Locations
- bnai zion MCRecruiting
Outcomes
Primary Outcome Measures
salivaa volume
quality of life related to salivation
Secondary Outcome Measures
Full Information
NCT ID
NCT00408759
First Posted
December 6, 2006
Last Updated
December 6, 2006
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00408759
Brief Title
Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Official Title
Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
xerostomia, hypnosis, dry mouth, radiotherapy, head and neck cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
hypnosis
Primary Outcome Measure Information:
Title
salivaa volume
Title
quality of life related to salivation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
radiotherapy for head and neck cancer
xerostomia
Exclusion Criteria:
psychiatric illness (present or past)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
elad schiff
Phone
972482654767
Email
eschiff@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
gorge mogilner
Phone
97248359359
Email
eschiff@bezeqint.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elad Schiff
Organizational Affiliation
Bnai Zion MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
bnai zion MC
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
elad schiff
Phone
97248359767
Email
eschiff@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Gorge Mogilner
First Name & Middle Initial & Last Name & Degree
Noam Yarom
First Name & Middle Initial & Last Name & Degree
Ilana Dowek
12. IPD Sharing Statement
Learn more about this trial
Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
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