XerostomiaPhase 4SMILENCT00466388
Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia
A Phase 4 study testing Cevimeline in people with Xerostomia, run by American Academy of Otolaryngology-Head and Neck Surgery Foundation at 7 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on the oral health of patients who have dry mouth which was caused by radiation therapy that was given for treatment of head and/or neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Cevimeline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2007to Aug 2009
- Phase
- Phase 4
- 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
- Subject is at least 18 years old and able to give written informed consent
- Subject has received external beam radiotherapy > 4000 cGy for SCCA of the head and/or neck
- Radiation therapy was completed at least 16 weeks (4 months) prior to enrollment into the study but not greater than 52 weeks (12 months)
- Radiation included at least three of four of the major salivary glands (submandibular and parotid glands) in the initial field (boost fields may or may not include the parotid gland)
- Primary therapy was designed with curative intent. Surgery is permitted if the remaining inclusion criteria are met
- Grade 1 or 2 xerostomia by CTC version 3.0 criteria (Appendix D)
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- Demonstratable salivary flow as assessed by the clinician after administration of a potent sialogogue such as lemon juice (1 teaspoon)
- Subject has at least one anatomically intact parotid gland and one submandibular gland
- ECOG performance status of 0, 1, or 2
- An EKG obtained has been performed in the past 6 months showing no arrhythmias or contraindication to administration of a muscarinic agent AND there has been no interval change in cardiac health
- Subject is able to eat an oral diet to maintain adequate hydration and nutrition
- Subject has provided informed consent
- Subject is English speaking and of sufficient mental capacity to comply with the study requirements
- Female subjects of child bearing potential have a negative serum pregnancy test and agree to use an approved method of birth control
Who cannot join
- Subject has a life expectancy less than 12 months.
- Subject is known or suspected to have persistent disease after curative intent
- Subject is greater than 12 months out from completion of radiation therapy
- Subject is pregnant or nursing
- Subject had previous cancer of the head and/or neck and is being treated with a second course of radiation therapy
- Subject has a history of an autoimmune disease with pretreatment xerostomia (i.e. Sjogrens) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure
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- Subject has had resection of both parotid glands
- Subject has history of cardiomyopathy or untreated moderate to severe CAD
- Subject has known cardiac arrhythmias
- Subject has grade 3 xerostomia (CTC v.3)or no demonstratable salivary flow after the test dose by visual inspection
- Subject has history of significant renal or hepatic impairment
- Subject uses a gastrostomy tube for nutrition supplementation
- Subject is taking medications specified in Appendix C
- Subject is taking or has taken any investigational new drug within the last 30 days or is planning to take such a drug during the course of this study
- Subject has a contraindication to administration of muscarinic medications.
- Subject has been treated previously with a muscarinic agent for xerostomia (i.e., Pilocarpine HCl)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Colorado Springs, Colorado
University of Kansas Medical Center
Kansas City, Kansas, 66160
Commonwealth Ear, Nose and Throat
Louisville, Kentucky, 40207
Associated Otolaryngologist
Palmyra, Pennsylvania, 17078
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Carle Clinic Association
Urbana, Illinois, 61801
Fauquier ENT Consultants
Warrenton, Virginia, 20186
About this study
Official title: An Investigator-Initiated,Multicenter,Randomized,Double-Blind Placebo-Controlled Design Study to Assess the Effectiveness of CeviMeline to Improve OraL Health in Patients With XErostomia Secondary to Radiation Therapy for Treatment of Head and Neck Squamous Cell Carcinoma
The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on the oral health of patients who have dry mouth which was caused by radiation therapy that was given for treatment of head and/or neck cancer.
Read the detailed description
Treatment of advanced head and neck squamous cell carcinoma (SCCA) requires aggressive therapy often combining surgical interventions with radiation therapy. Besides surveillance for persistent or recurrent cancer, clinicians seek to help minimize the side effects resulting from these aggressive treatments. Xerostomia, or "dry mouth", impacts each patient's long term health and quality of life due to the significant and diverse health consequences of having too little saliva. Normal swallowing, speaking, resistance to infection, and taste acuity are health domains that are affected by dry mouth. Psycho-social functioning decreases for many of these patients due to the extra effort to communicate and socialize (Locker D 2004).
Xerostomia is often a consequence of radiation treatment (XRT), especially when the XRT fields encompass the parotid glands and submandibular glands bilaterally. The disability and consequences of xerostomia extend beyond dysphagia, poor appetite secondary to difficulty of mastication, and loss of taste (Chambers et al. Xerostomia 2004). Since saliva is essential to normal oral flora and healthy teeth, the lack of saliva in these patients can dramatically and rapidly result in a decline of the patient's oral health. Dental complications can occur and present significant ongoing medical and surgical problems.
Our study proposes to use the Oral Health Impact Profile, OHIP-49, to measure disease-specific quality of life and functional outcomes due to radiation related xerostomia in head and neck cancer patients. The evaluation of patient QOL concomitantly with patient functioning as proposed in the SMILE protocol is an "evidence study to evaluate treatment effectiveness". The use of patient-oriented outcome measures are increasingly important to health insurers and government, but these measures are also aligned with the World Health Organization's mandate that health is a resource to manage which must be utilized and preserved so that individuals experience and gain satisfaction from living (Epstein J.1986). The OHIP-49 is patient reported outcome measure which is publicly available, validated in adult populations world-wide, and can be used an effectiveness measure. The questions are easy to answer and are based upon a 5 level likert type scale reflecting frequency of "bother" within individual psychosocial domains.
- Conditions
- Xerostomia
- Being tested
- Cevimeline
- Keywords
- dry mouth
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CevimelineDrug
Also called evoxac
| Study group | Role | What they receive |
|---|---|---|
| Cevimeline | Experimental | Evoxac tid for xerostomia Receives: Drug: Cevimeline |
| Placebo | Placebo comparator | sugar pill Receives: Drug: Cevimeline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of increased salivary flow due to treatment with cevimeline compared to placebo in patient reported oral health using the OHIP-49
Measured: 6 weeks
Secondary outcomes (3)
To evaluate if increased salivary flow due to cevimeline treatment results in improved patient reported quality of life using the UW-QOL-HN
Measured: 6 weeks
To evaluate which subscales of the OHIP-49 are improved most by increased salivary flow due to cevimeline treatment
Measured: 6 weeks
To evaluate which subscales of the UW-QOL-HN are improved most by increased salivary flow due to cevimeline treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionAug 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- David Witsell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466388
- Sponsor's protocol ID
- AAO-101
- Acronym
- SMILE
- Status last verified
- May 2014
- First submitted
- 23 Apr 2007
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated,Multicenter,Randomized,Double-Blind Placebo-Controlled Design Study to Assess the Effectiveness of CeviMeline to Improve OraL Health in Patients With XErostomia Secondary to Radiation Therapy for Treatment of Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00466388
- Acronym / sponsor ID
- SMILE / AAO-101
- Conditions
- Xerostomia
- Keywords
- dry mouth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- American Academy of Otolaryngology-Head and Neck Surgery FoundationUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 24 Apr 2007 (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.
The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on the oral health of patients who have dry mouth which was caused by radiation therapy that was given for treatment of head and/or neck cancer.
Detailed description
Treatment of advanced head and neck squamous cell carcinoma (SCCA) requires aggressive therapy often combining surgical interventions with radiation therapy. Besides surveillance for persistent or recurrent cancer, clinicians seek to help minimize the side effects resulting from these aggressive treatments. Xerostomia, or "dry mouth", impacts each patient's long term health and quality of life due to the significant and diverse health consequences of having too little saliva. Normal swallowing, speaking, resistance to infection, and taste acuity are health domains that are affected by dry mouth. Psycho-social functioning decreases for many of these patients due to the extra effort to communicate and socialize (Locker D 2004).
Xerostomia is often a consequence of radiation treatment (XRT), especially when the XRT fields encompass the parotid glands and submandibular glands bilaterally. The disability and consequences of xerostomia extend beyond dysphagia, poor appetite secondary to difficulty of mastication, and loss of taste (Chambers et al. Xerostomia 2004). Since saliva is essential to normal oral flora and healthy teeth, the lack of saliva in these patients can dramatically and rapidly result in a decline of the patient's oral health. Dental complications can occur and present significant ongoing medical and surgical problems.
Our study proposes to use the Oral Health Impact Profile, OHIP-49, to measure disease-specific quality of life and functional outcomes due to radiation related xerostomia in head and neck cancer patients. The evaluation of patient QOL concomitantly with patient functioning as proposed in the SMILE protocol is an "evidence study to evaluate treatment effectiveness". The use of patient-oriented outcome measures are increasingly important to health insurers and government, but these measures are also aligned with the World Health Organization's mandate that health is a resource to manage which must be utilized and preserved so that individuals experience and gain satisfaction from living (Epstein J.1986). The OHIP-49 is patient reported outcome measure which is publicly available, validated in adult populations world-wide, and can be used an effectiveness measure. The questions are easy to answer and are based upon a 5 level likert type scale reflecting frequency of "bother" within individual psychosocial domains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cevimeline | Experimental | Drug: CevimelineEvoxac tid for xerostomia |
| Placebo | Placebo comparator | Drug: Cevimelinesugar pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is at least 18 years old and able to give written informed consent
- Subject has received external beam radiotherapy > 4000 cGy for SCCA of the head and/or neck
- Radiation therapy was completed at least 16 weeks (4 months) prior to enrollment into the study but not greater than 52 weeks (12 months)
- Radiation included at least three of four of the major salivary glands (submandibular and parotid glands) in the initial field (boost fields may or may not include the parotid gland)
- Primary therapy was designed with curative intent. Surgery is permitted if the remaining inclusion criteria are met
Key exclusion criteria (16 listed)
- Subject has a life expectancy less than 12 months.
- Subject is known or suspected to have persistent disease after curative intent
- Subject is greater than 12 months out from completion of radiation therapy
- Subject is pregnant or nursing
- Subject had previous cancer of the head and/or neck and is being treated with a second course of radiation therapy
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 |
|---|---|---|
| CevimelineAlso: evoxac | Drug | Cevimeline, Placebo |
Primary outcome
To assess the impact of increased salivary flow due to treatment with cevimeline compared to placebo in patient reported oral health using the OHIP-49
Time frame: 6 weeks
3 secondary outcomes
To evaluate if increased salivary flow due to cevimeline treatment results in improved patient reported quality of life using the UW-QOL-HN
Time frame: 6 weeks
To evaluate which subscales of the OHIP-49 are improved most by increased salivary flow due to cevimeline treatment
Time frame: 6 weeks
To evaluate which subscales of the UW-QOL-HN are improved most by increased salivary flow due to cevimeline treatment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
David Witsell, MD principal investigator
Duke University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cevimeline in people with Xerostomia, run by American Academy of Otolaryngology-Head and Neck Surgery Foundation at 7 sites in United States.
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 14 inclusion and 16 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: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the impact of increased salivary flow due to treatment with cevimeline compared to placebo in patient reported oral health using the OHIP-49 (time frame: 6 weeks). 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 22 May 2014.