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

The University of Chicago

Status and phase: Withdrawn; Phase 2

Conditions: Oropharyngeal Cancer; HPV-Related Squamous Cell Carcinoma

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03423264

IRB17-1550

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Gabapentin

Experimental group

Description:

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.

Treatment:

Drug: Gabapentin

Supportive Care Only

No Intervention group

Description:

Participants will receive standard best supportive care medications as per their treating physician's recommendation.