Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients - Full Text View

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 II

MedlinePlus related topics:

Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-availability Study

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

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
	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

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