Neoplasms

All Conditions

Digestive System Diseases

Mouth and Tooth Diseases

Symptoms and General Pathology

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Gastroesophageal Reflux

Xerostomia

Mucositis

Heartburn

Oropharyngeal Neoplasms

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

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.

David I. Rosenthal, MD, MA, BA

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

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 this study, you will be assigned to 1 of 2 groups, based on the results of your screening tests.

If you are assigned to Group 1, you will not receive any study drug, but you will complete the study visits and radiation therapy, as described below.

If you are assigned to Group 2, you will receive Dexlansoprazole.

Study Drug Administration:

Dexlansoprazole is an dissolving tablet that is taken by mouth. It dissolves on the tongue. It should not be swallowed whole with water like a regular pill. You will take 1 tablet, once daily. The study drug should be taken first thing in the morning on an empty stomach, and then you should not eat or drink anything but water for 30-45 minutes after taking the study drug.

Study Visits:

Before you have the scheduled radiation therapy, you will have study visits. At these visits, the following tests and procedures will be performed:

* You will have a pH-probe test performed.
* You will complete the PRO questionnaires.
* You will have a whole mouth salivary flow (WMSF) test. To perform this test, you will chew a piece of non-flavored gum, and spit into a cup for after about 5 minutes. The amount saliva will be weighed and recorded to compare it the amount recorded after radiation therapy.

Radiation Therapy:

After you have completed the study visits, you will have the scheduled radiation therapy. You will be asked to sign a separate consent form for this.

Length of Study:

You will remain on study from the beginning of radiation therapy until the 6-12 week follow up visit is completed. After your participation on this study is over, you should speak with your primary doctor about long term treatment. If your acid reflux disease gets worse while on study, you will be recommended for a gastrointestinal (GI) evaluation and treatment. If you experience intolerable side effects, you will be taken off study.

Follow-Up Visits:

About 6-12 weeks after you have completed radiation therapy, you will have a follow up visit. At this visit, the following tests and procedures will be performed:

* You will have a pH-probe test performed.
* You will complete the PRO questionnaires.

This is an investigational study. Dexlansoprazole is FDA approved and commercially available for the treatment of acid reflux disease.

Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.

Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

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

TAP Pharmaceutical Products Inc.

M.D. Anderson Cancer Center

Recurrence

Barrett Esophagus

Metaplasia

Disease Attributes

Precancerous Conditions

Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months.

Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months.

Dexlansoprazole placebo-matching capsules

Dexlansoprazole Placebo

Medical Director Clinical Science

This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).

The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) with RFA. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Dexlansoprazole 60 mg once a day and placebo (this is a capsule that looks like the study drug but has no active ingredient) once a day
* Dexlansoprazole 60 mg twice a day.

All participants will be asked to take one capsule twice a day at the same time each day throughout the study.

This randomized, double-blind, multi-center, parallel group trial will be conducted in North America. The overall time to participate in this study is up to 13 months. Participants will make 5 visits to the clinic, and will undergo a safety follow-up assessment 30 days after the last dose of study drug.

Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

A Randomized, Double-Blind, Phase 4 Study to Evaluate the Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.

Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.

The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.

The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.

Dexlansoprazole 60 mg QD

Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.

Dexlansoprazole 60 mg BID

Total

Age, Continuous

Sex: Female, Male

Not Hispanic or Latino

Race/Ethnicity, Customized

White

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

Never smoked

Ever smoked

Smoking History

16-20 years

Greater than (>) 20 years

Baseline measure was analyzed for those participants who have ever smoked tobacco.

Number of Smoking Years for Ever Smoked

Non smoker

Smoker

Current Smoking Status

101-200 packs

301-400 packs

>400 packs

Unknown

Baseline measure was analyzed in the participants who currently or have ever smoked tobacco.

Number of Packs Per Year

Never drank alcohol

Drank alcohol

Alcohol History

>20 years

Baseline measure was analyzed for those participants who currently or have ever drank alcohol.

Number of Drinking Years

0-5 drinks

6-10 drinks

>30 drinks

Number of Drinks Per Week

Current drinker

Non-drinker

Current Alcohol Status

The safety set included all participants who were randomized and received 1 dose of study drug.

Medical Director

The Intent-to-treat (ITT) population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)

The ITT population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Percentage of Participants With Recurrence of IM With Dysplasia

The ITT population where EE assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Percentage of Participants With Erosive Esophagitis (EE)

Baseline

Change at Month 12

The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy	NCT00928161	Head and Neck C... Oropharyngeal C... Gastroesophagea...	Dexlansoprazole	18 Years -	M.D. Anderson Cancer Center
Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation	NCT02162758	Barrett's Esoph...	Dexlansoprazole Dexlansoprazole...	18 Years - 80 Years	Takeda
Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation	NCT02162758	Barrett's Esoph...	Dexlansoprazole Dexlansoprazole...	18 Years - 80 Years	Takeda
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy	NCT00928161	Head and Neck C... Oropharyngeal C... Gastroesophagea...	Dexlansoprazole	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for dexlansoprazole