Clinical Trials Logo
  1. Home
  2. Oropharyngeal Cancer
  3. NCT03423264

PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing

Oropharyngeal Cancer Clinical Trial

Official title:
A Phase II Randomized Trial of Prophylactic Gabapentin Plus Best Supportive Care Versus Best Supportive Care Alone for Patients Receiving Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Locoregionally-Advanced, HPV-Related Oropharyngeal Cancer: An Optima II Secondary Study

Clinical Trial Summary

Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.

Clinical Trial Description

Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). Primary objective: To compare rates of opioid requirement as a function of supportive care in patients experiencing CTCAE grade ≥2 oral mucositis at completion of radiation or chemoradiation as part of OPTIMA II Secondary objectives: To compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin. To investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03423264
Study type Interventional
Source University of Chicago
Contact Daniel Haraf, MD
Phone (773) 702-5976
Email dharaf@radonc.uchicago.edu
Status Recruiting
Phase Phase 2
Start date January 22, 2018
Completion date September 1, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03656133 - Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers N/A
Terminated NCT02225496 - Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma Phase 2
Withdrawn NCT01767961 - Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer N/A
Completed NCT01695122 - Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT01435252 - A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Withdrawn NCT00951470 - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema N/A
Completed NCT01358097 - Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy N/A
Completed NCT01342978 - Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time N/A
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Recruiting NCT05363709 - BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients Phase 2
Completed NCT02280811 - T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers Phase 2
Active, not recruiting NCT03777384 - EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT06121102 - Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain N/A
Recruiting NCT02984410 - Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma N/A
Recruiting NCT02960724 - uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Phase 2
Completed NCT02934724 - Impact of HPV Vaccine On The Prevalence Of HPV In Norway
Withdrawn NCT00928161 - Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy N/A
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research