Status:
WITHDRAWN
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
TAP Pharmaceutical Products Inc.
Conditions:
Head and Neck Cancer
Oropharyngeal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn if radiation-induced xerostomia \[RIX\] (dry mouth) causes, or worsens the effects of, acid reflux (heartburn and heartburn-like symptoms) in head ...
Detailed Description
The Study Drug: Dexlansoprazole is designed to block the production of excess stomach acid that is the cause of acid reflux disease. Study Groups: If you are found to be eligible to take part in th...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Head and neck cancer (HNC) Oropharynx cancer (OPC) patients who are adults \> 18 years of age, dispositioned to receive curative RT with bilateral neck (including) parotid irradiation with or without chemotherapy.
- Radiation Therapy (3D conformal or IMRT).
Exclusion
- Subjects unable to tolerate pH-probe in past.
- Subjects currently on proton-pump inhibitor (PPI), daily antacids and daily H2 antagonists.
- Prior history of esophago-gastric surgery.
- Symptoms of active gastrointestinal bleeding (melena, hematemesis).
- Known hepatic cirrhosis or esophageal varices.
- Prior esophageal perforation.
- Pregnant or lactating woman. Women of childbearing potential who have not undergone a hysterectomy with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable and appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- Subjects with allergies or sensitivities to proton-pump inhibitors.
- Patients who cannot complete study follow-up and compliance with study protocol.
- Patients on Plavix (if medically appropriate)
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00928161
Start Date
November 1 2012
Last Update
September 7 2012
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