Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

NCT00928161 | Withdrawn

• 1 other identifier: 2007-0944
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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. 1.To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms
2. 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. 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. 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. 5.Compare findings from the patient reported outcome (PRO) instruments used

Conditions

Head and Neck Cancer; Oropharyngeal Cancer; Gastroesophageal Reflux Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency of acid reflux episode (during each 24 hour pH probe)

  Before radiotherapy and again at 6 weeks following radiotherapy

Study Arms (2)

Group 1

NO INTERVENTION

Patients with no acid reflux.

Group 2

ACTIVE COMPARATOR

Patients with acid reflux.

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

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.

Also known as: Prevacid, Prevacid Solu-Tab

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• TAP Pharmaceutical Products Inc.: collaborator

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Gastroesophageal Reflux; Mucositis; Xerostomia; Heartburn

Interventions

Dexlansoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Mouth Diseases; Salivary Gland Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David I. Rosenthal, MD, MA, BA

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 25, 2009
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Last Updated: September 7, 2012

Record last verified: 2012-09