Head and Neck Cancer Clinical Trial
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
NCT number | NCT00928161 |
Other study ID # | 2007-0944 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | June 23, 2009 |
Last updated | September 5, 2012 |
Start date | November 2012 |
Verified date | September 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | TAP Pharmaceutical Products Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of acid reflux episode (during each 24 hour pH probe) | Before radiotherapy and again at 6 weeks following radiotherapy | No |
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