Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT00928161
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00928161
Study Brief:
Protocol Section:
NCT00928161