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NCT00408759 Clinical Trial

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

Xerostomia Clinical Trial

Official title:
Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00408759
Other study ID # eschiff
Secondary ID
Status Recruiting
Phase Phase 2
First received December 6, 2006
Last updated December 6, 2006
Start date November 2006
Est. completion date December 2006

Study information
Verified date December 2006
Source Bnai Zion Medical Center
Contact elad schiff
Phone 972482654767
Email eschiff@email.arizona.edu
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- radiotherapy for head and neck cancer

- xerostomia

Exclusion Criteria:

- psychiatric illness (present or past)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• hypnosis

Locations
Country Name City State
Israel bnai zion MC Haifa

Sponsors (1)
Lead Sponsor Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary salivaa volume
Primary quality of life related to salivation
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