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

Phase 2

Withdrawn

• Conditions: Oropharyngeal Cancer; HPV-Related Squamous Cell Carcinoma
• Interventions: Drug: Gabapentin

• Registration Number: NCT03423264
• Lead Sponsor: University of Chicago

Brief 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.

Detailed 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 Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-06
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Participants randomized to this arm will receive gabapentin beginning on evening of the first day of radiation treatment at a dose of 600 mg. Gabapentin will continue to be taken twice a day (morning and evening) for the next 4 days of radiation treatment at increasing doses (up to 900 mg). Participants will continue to receive standard best supportive care medications as per their treating physician's recommendation.

Primary Outcome Measures

Name	Time	Method
Rate of opioid use at end of radiation treatment	5 days	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.

Secondary Outcome Measures

Name	Time	Method
Total opioid dosage during radiation treatment	5 days	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.
Differences in head and neck symptoms	24 months	Measured by changes in patient reported head and neck specific symptoms
Differences in overall quality of life	24 months	Measured by changes in patient reported symptoms
Differences in chemotherapy-induced peripheral neuropathy symptoms	24 months	Measured by patient reported symptoms
Swallowing Function	12 weeks	1. Normal; 2. Within functional limits: abnormal oral or pharyngeal stage but able to eat regular diet; no modifications or swallowing precautions; 3. Mild impairment: mild dysfunction in oral or pharyngeal stage, requires modified diet; no therapeutic swallowing precautions; 4. Mild-moderate impairment: mild dysfunction in oral and pharyngeal stage, requires modified diet and therapeutic swallowing precautions; 5. Moderate impairment: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions; 6. 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; 7. Severe impairment: severe dysfunction with significant aspiration or inadequate oropharyngeal transit to esophagus, NPO, requires primary enteral feeding support
Treatment Delays	7 weeks	Determine rate of unplanned radiation treatment delays.
Side Effects	13 weeks	Determine rate of gabapentin related side effects as per CTCAE v4.
Feeding Tube Dependence	24 months	Assessment of rates of feeding tube dependence during and after radiation treatment

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States