Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	TAP Pharmaceutical Products Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00928161

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.

Primary Objective:

Determine if radiation induced xerostomia (RIX) increases the frequency or duration of acid-reflux when re-measured approximately 6 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 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: Lansoprazole

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer GERD Head and Neck Cancer Heartburn

Drug Information available for: Lansoprazole

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	July 2010
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: No Intervention Patients with no acid reflux.
Group 2: Active Comparator Patients with acid reflux.	Drug: Lansoprazole Dissolving tablet taken by mouth (30 mg tablet), two times a day. First dose in morning on empty stomach, then nothing but water for 30-45 minutes afterwards; second dose 12 hours after first, again with nothing but water for at least 1 hour before and 30-45 minutes after.

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928161

Contacts

Contact: David I. Rosenthal, MD, MA, BA

713-563-2300

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

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:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( David I. Rosenthal, MD, MA, BA / Professor )
Study ID Numbers:	2007-0944
Study First Received:	June 23, 2009
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00928161 History of Changes
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
Lansoprazole
Prevacid
Prevacid Solu-Tab
GERD

Additional relevant MeSH terms:

Anti-Infective Agents
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Pharyngeal Neoplasms
Enzyme Inhibitors
Gastroesophageal Reflux
Pharyngeal Diseases
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Anti-Ulcer Agents
Lansoprazole
Stomatognathic Diseases
Esophageal Diseases
Oropharyngeal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010