PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2018 |
| Start Date: | January 22, 2018 |
| End Date: | June 2020 |
| Contact: | Daniel Haraf, MD |
| Email: | dharaf@radonc.uchicago.edu |
| Phone: | (773) 702-5976 |
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
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.
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.
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.
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.
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
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