MDACC Study Summary 2007-0024 (Archived)

Study Summary
No. 2007-0024:.......Head And Neck......Mark Chambers......Head/Neck Surgery

Study Summary Title



Study Summary Number:	2007-0024

Study 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

Physician

New Patient Referral



Name:	Mark Chambers	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Head/Neck Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6510 Contact us about clinical trials

General Information



Disease Group:	Head And Neck	Supported By:	American Academy of Otolaryngology, Head and Neck Surgery Foundation Duke Clinical Research Institute

Phase of Study:	N/A	Return Visit:	1 Visit

Treatment Agents:	Cevimeline	Home Care:	Patients will self administer assigned medication pills

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out if Evoxac® (cevimeline) can help increase saliva flow in patients who have dry mouth because of radiation therapy for head and neck cancer. Researchers also want to learn whether patients' quality of life may improve once the saliva flow is increased.

Study Objectives / Outcomes

Primary Objective
To assess the impact of increased salivary flow due to treatment with cevimeline at a dose of 30 mg three times daily compared to placebo in patient reported oral health using the OHIP-49 in subjects with xerostomia secondary to radiation therapy for cancer in the head and neck.

Secondary Objectives
1. To evaluate if increased salivary flow due to cevimeline treatment results in improved patient reported quality of life using the UW-QOL-HN.
2. To evaluate which subscales (psychometric domains) of the OHIP-49 are improved most by increased salivary flow due to cevimeline treatment.
3. To evaluate which subscales of the UW-QOL-HN are improved most by increased salivary flow due to cevimeline treatment.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	05/16/2007

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	108

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Subject is at least 18 years old and able to give written informed consent

2) Subject has received external beam radiotherapy > 4000 cGy for SCCA of the head and/or neck

3) Radiation therapy was completed at least 16 weeks (4 months) prior to enrollment into the study but not greater than 52 weeks (12 months)

4) Radiation included at least three or four of the major salivary glands (submandibular and parotid glands) in the initial field (boost fields may or may not include the parotid gland)

5) Primary therapy was designed with curative intent. Surgery is permitted if the remaining inclusion criteria are met

6) Grade 1 or 2 xerostomia by CTC version 3.0 criteria

7) Demonstrateable salivary flow as assessed by the clinician after administration of a potent sialogogue such as lemon juice (1 teaspoon)

8) Subject has at least one anatomically intact parotid gland and one submandibular gland

9) ECOG performance status of 0, 1 or 2

10) 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

11) Subject is able to eat an oral diet to maintain adequate hydration and nutrition

12) Subject has provided informed consent

13) Subject is English speaking and of sufficient mental capacity to comply with the study requirements

14) Female subjects of child bearing potential have a negative serum or urine pregnancy test and agree to use and approved method of birth control

Exclusion Criteria:

1) Subject is greater than 12 months out from completion of radiation therapy

2) Subject is pregnant or nursing

3) Subject had previous cancer of the head and/or neck and is being treated with a second course of radiation therapy

4) Subject has a history of an autoimmune disease with pretreatment xerostomia (i.e. Sjogren's) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure

5) Subject has had resection of both parotid glands

6) Subject has history of cardiomyopathy or untreated moderate to severe CAD

7) Subject has known cardiac arrhythmias

8) Subject has grade 3 xerostomia (CTC v. 3) or no demonstratable salivary flow after the test done by visual inspection

9) Subject has history of significant renal or hepatic impairment

10) Subject uses gastrostomy tube for nutrition supplementation

11) Subject is taking medications specified in Appendix C

12) 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

13) Subject has a contraindication to administration of muscarinic medications

14) Subject has been treated previously with a muscarinic agent for xerostomia (i.e. Pilocarpine HCL)

15) Acute iritis, or narrow angle (angle closure) glaucoma at present or at any time in the past.

16) History of uncontrolled cardiovascular disease in a subject who may be unable to compensate for transient changes in hemodynamics or rhythm induced by cholinergic agents.

17) History of significant pulmonary disease (i.e. COPD, emphysema, asthma, chronic bronchitis).

Links

Registration Number: NCT00466388
Study Information on Clinical Trials Registry (clinicaltrials.gov)