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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03423264
• Other study ID #: IRB17-1550
• Status: Recruiting
• Phase: Phase 2
• Start date: January 22, 2018
• Est. completion date: September 1, 2025

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Daniel Haraf, MD
• Phone: (773) 702-5976
• Email: dharaf[@]radonc.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrollment to OPTIMA II trial (NCT03107182)

Exclusion Criteria:

• Ineligible for enrollment to OPTIMA II trial (NCT03107182)

• Prior gabapentin therapy

• Creatinine clearance of < 45 mL/minute

• Documented intolerance, allergy, or hypersensitivity to gabapentin

• Hemodialysis or peritoneal dialysis

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• HPV-Related Squamous Cell Carcinoma
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Drug:
• Gabapentin
Gabapentin taken as follows: Day 1 (evening): 600 mg Day 2 (morning): 600 mg Day 2 (evening): 600 mg Day 3 (morning): 600 mg Day 3 (evening): 900 mg Day 4 (morning): 900 mg Day 4 (evening): 900 mg Day 5 (morning): 900 mg Day 5 (noon): 900 mg Day 5 (evening): 900 mg

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of opioid use at end of radiation treatment	Comparison of opioid use as part of best supportive care in patients with CTCAE grade = 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.	5 days
Secondary	Total opioid dosage during radiation treatment	Comparison of total opioid dosage given as part of best supportive care in patients with CTCAE grade = 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.	5 days
Secondary	Differences in head and neck symptoms	Measured by changes in patient reported head and neck specific symptoms	24 months
Secondary	Differences in overall quality of life	Measured by changes in patient reported symptoms	24 months
Secondary	Differences in chemotherapy-induced peripheral neuropathy symptoms	Measured by patient reported symptoms	24 months
Secondary	Swallowing Function	Normal; Within functional limits: abnormal oral or pharyngeal stage but able to eat regular diet; no modifications or swallowing precautions; Mild impairment: mild dysfunction in oral or pharyngeal stage, requires modified diet; no therapeutic swallowing precautions; Mild-moderate impairment: mild dysfunction in oral and pharyngeal stage, requires modified diet and therapeutic swallowing precautions; Moderate impairment: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions; Moderate-severe dysfunction: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions; requires primary enteral feeding support; Severe impairment: severe dysfunction with significant aspiration or inadequate oropharyngeal transit to esophagus, NPO, requires primary enteral feeding support	12 weeks
Secondary	Feeding Tube Dependence	Assessment of rates of feeding tube dependence during and after radiation treatment	24 months
Secondary	Treatment Delays	Determine rate of unplanned radiation treatment delays.	7 weeks
Secondary	Side Effects	Determine rate of gabapentin related side effects as per CTCAE v4.	13 weeks