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

• Sponsor: Bnai Zion Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00408759
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Days): 30
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia	Behavioral: hypnosis	Phase 2

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.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
• Study Start Date: Nov 1, 2006
• Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. salivaa volume []

2. quality of life related to salivation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• radiotherapy for head and neck cancer

• xerostomia

Exclusion Criteria:

• psychiatric illness (present or past)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	bnai zion MC	Haifa		Israel

Sponsors and Collaborators

• Bnai Zion Medical Center

Investigators

• Principal Investigator: Elad Schiff, Bnai Zion MC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00408759
• Other Study ID Numbers: eschiff
• First Posted: Dec 7, 2006
• Last Update Posted: Dec 7, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: xerostomia; hypnosis; dry mouth; radiotherapy; head and neck cancer
• Additional relevant MeSH terms: Head and Neck Neoplasms; Xerostomia

Study Results

No Results Posted as of Dec 7, 2006