NCT00408759

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
Last Updated

December 7, 2006

Status Verified

December 1, 2006

First QC Date

December 6, 2006

Last Update Submit

December 6, 2006

Conditions

Xerostomia

Keywords

xerostomiahypnosisdry mouthradiotherapyhead and neck cancer

Outcome Measures

Primary Outcomes (2)

  • salivaa volume

  • quality of life related to salivation

Interventions

hypnosisBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • radiotherapy for head and neck cancer
  • xerostomia

You may not qualify if:

  • psychiatric illness (present or past)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

bnai zion MC

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

XerostomiaHead and Neck Neoplasms

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Elad Schiff

    Bnai Zion MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

elad schiff

CONTACT

972482654767eschiff@email.arizona.edu

gorge mogilner

CONTACT

97248359359eschiff@bezeqint.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 7, 2006

Study Start

November 1, 2006

Study Completion

December 1, 2006

Last Updated

December 7, 2006

Record last verified: 2006-12

Locations

IL(1)