Back to results

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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

eschiff@email.arizona.edu

First Name & Middle Initial & Last Name or Official Title & Degree

gorge mogilner

Phone

97248359359

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

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

We'll reach out to this number within 24 hrs