Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
This study has been withdrawn prior to enrollment.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00928161
First received: June 23, 2009
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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 and neck cancer (HNC) patients receiving radiation therapy.
Objectives:
Primary Objective:
Determine if radiation induced xerostomia (RIX) increases the frequency or duration of acid-reflux when re-measured approximately 6-12 weeks after RT (measured by # episodes, their duration, and Reflux Area Index (RAI). Reflux Area (RA) is the sum of the area under the curve for all episodes of pH<4 recorded during the study in units of Ph*minutes. The Reflux area index (RAI) is the RA corrected for the duration of the study (RA x 100/study duration).
Secondary Objectives:
- To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms
- Correlate RAI and # episodes of acid reflux with salivary flow before and after RT to determine if radiation induced hyposalivation is associated with more reflux events and symptoms.
- For patients with no pre-RT pathologic acid reflux, determine if RIX leads to conversion to acid-positive reflux measured approximately 6-12 weeks after RT.
- Correlate office indirect laryngoscopy findings (posterior commissure thickening, cobble-stoning, granulomas, and arytenoids erythema or edema) suggestive of acid reflux in OPC patients with pH-probe findings as was done in larynx cancer (Lewin et al)
- Compare findings from the patient reported outcome (PRO) instruments used
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer Oropharyngeal Cancer Gastroesophageal Reflux Disease |
Drug: Dexlansoprazole |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation and Treatment of Reflux Disease in Patients With Head and Neck Cancer Undergoing Radiation Therapy That Causes Significant Mucositis in the Reflux Field and Xerostomia |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Frequency of acid reflux episode (during each 24 hour pH probe) [ Time Frame: Before radiotherapy and again at 6 weeks following radiotherapy ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Group 1
Patients with no acid reflux.
|
|
|
Active Comparator: Group 2
Patients with acid reflux.
|
Drug: Dexlansoprazole
Dissolving tablet taken by mouth (60 mg tablet), once a day. Take dose first thing in morning on empty stomach, then nothing but water for 30-45 minutes afterwards.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00928161 History of Changes |
| Other Study ID Numbers: | 2007-0944 |
| Study First Received: | June 23, 2009 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Reflux Disease Acid-reflux Head and Neck Cancer HNC Radiation Therapy Mucositis Radiation-induced xerostomia |
RIX Dry Mouth Heartburn Dexlansoprazole Prevacid Prevacid Solu-Tab GERD |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Head and Neck Neoplasms Oropharyngeal Neoplasms Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms |
Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Lansoprazole Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013