Status:
COMPLETED
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
Lead Sponsor:
Henry Ford Health System
Conditions:
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. The investigators hypothesize that gabapenti...
Detailed Description
The specific aims of this proposed study include the following: * Evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage III or IV o...
Eligibility Criteria
Inclusion
- Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
- Age ≥ 18.
- ECOG performance status ≤ 1.
- Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.
Exclusion
- Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
- Patients with metastatic disease are excluded from this clinical trial.
- Patient with allergies or hypersensitivity to gabapentin.
- Patients receiving surgery as part of their definitive management.
- Patients who have received prior chemotherapy or radiation therapy.
- Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
- Uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
June 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03269344
Start Date
June 5 2017
End Date
December 9 2020
Last Update
January 26 2022
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202