XerostomiaPhase 2NCT00408759
Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
A Phase 2 study testing hypnosis in people with Xerostomia, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- hypnosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2006to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiotherapy for head and neck cancer
- xerostomia
Who cannot join
- psychiatric illness (present or past)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
bnai zion MC
Haifa
elad schiff, 97248359767, eschiff@email.arizona.edu
Gorge Mogilner
About this study
Official title: Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
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.
Read the 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.
- Conditions
- Xerostomia
- Being tested
- hypnosis
- Keywords
- xerostomia, hypnosis, dry mouth, radiotherapy, head and neck cancer
- Medical subject headings
- Xerostomia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
salivaa volume
quality of life related to salivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Elad Schiff, Principal investigator, Bnai Zion MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408759
- Sponsor's protocol ID
- eschiff
- Status last verified
- Dec 2006
- First submitted
- 6 Dec 2006
- Last updated
- 7 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00408759
- Acronym / sponsor ID
- eschiff
- Conditions
- Xerostomia
- Keywords
- xerostomia, hypnosis, dry mouth, radiotherapy, head and neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Nov 2006
- Study completion
- Dec 2006
- First posted
- 7 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- radiotherapy for head and neck cancer
- xerostomia
Key exclusion criteria (1 listed)
- psychiatric illness (present or past)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnosis | Behavioural | – |
Primary outcome
salivaa volume
quality of life related to salivation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elad Schiff principal investigator
Bnai Zion MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypnosis in people with Xerostomia, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact elad schiff (972482654767, eschiff@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivaa volume. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2006.