Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466388
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2007-04-23
Brief Title:
Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia
Sponsor:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Organization:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Study Overview
Official Title:
An Investigator-InitiatedMulticenterRandomizedDouble-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
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMILE
Brief 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 andor 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 patients 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 patients 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 Organizations mandate that health is a resource to manage which must be utilized and preserved so that individuals experience and gain satisfaction from living Epstein J1986 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
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 patients 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 Organizations mandate that health is a resource to manage which must be utilized and preserved so that individuals experience and gain satisfaction from living Epstein J1986 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None