Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

This study has been withdrawn prior to enrollment.
Sponsor:
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
  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:

  1. To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms
  2. 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.
  3. 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.
  4. 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)
  5. 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:
  • Prevacid
  • Prevacid Solu-Tab

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent.
  2. 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.
  3. Radiation Therapy (3D conformal or IMRT).

Exclusion Criteria:

  1. Subjects unable to tolerate pH-probe in past.
  2. Subjects currently on proton-pump inhibitor (PPI), daily antacids and daily H2 antagonists.
  3. Prior history of esophago-gastric surgery.
  4. Symptoms of active gastrointestinal bleeding (melena, hematemesis).
  5. Known hepatic cirrhosis or esophageal varices.
  6. Prior esophageal perforation.
  7. 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).
  8. Subjects with allergies or sensitivities to proton-pump inhibitors.
  9. Patients who cannot complete study follow-up and compliance with study protocol.
  10. Patients on Plavix (if medically appropriate)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00928161

Sponsors and Collaborators
M.D. Anderson Cancer Center
TAP Pharmaceutical Products Inc.
Investigators
Study Chair: David I. Rosenthal, MD, MA, BA UT MD Anderson Cancer Center
  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
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014