Head and Neck CancerNCT00928161
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
A study testing Dexlansoprazole in people with Head and Neck Cancer and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharyngeal Cancer, Gastroesophageal Reflux Disease
- What is being tested?
- Dexlansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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)
About this 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
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:
Read more
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
Read the detailed description
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.
- Being tested
- Dexlansoprazole
- 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
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms, Gastroesophageal Reflux, Mucositis, Xerostomia, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Also called Prevacid, Prevacid Solu-Tab
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Patients with no acid reflux. |
| Group 2 | Active comparator | Patients with acid reflux. Receives: Drug: Dexlansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acid reflux episode (during each 24 hour pH probe)
Measured: Before radiotherapy and again at 6 weeks following radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Responsible party
- Sponsor
- Investigators
- David I. Rosenthal, MD, MA, BA, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928161
- Sponsor's protocol ID
- 2007-0944
- Status last verified
- Sep 2012
- First submitted
- 23 Jun 2009
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00928161
- Acronym / sponsor ID
- 2007-0944
- Keywords
- Reflux Disease, Acid-reflux, Head and Neck Cancer, HNC, Radiation Therapy, Mucositis, Radiation-induced xerostomia, RIX
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Patients with no acid reflux. |
| Group 2 | Active comparator | Drug: DexlansoprazolePatients with acid reflux. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexlansoprazoleAlso: Prevacid, Prevacid Solu-TabDissolving 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. | Drug | Group 2 |
Primary outcome
Frequency of acid reflux episode (during each 24 hour pH probe)
Time frame: Before radiotherapy and again at 6 weeks following radiotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David I. Rosenthal, MD, MA, BA study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Dexlansoprazole in people with Head and Neck Cancer and Oropharyngeal Cancer, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of acid reflux episode (during each 24 hour pH probe) (time frame: Before radiotherapy and again at 6 weeks following radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.