Clinical trial NCT03423264: PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Oropharyngeal Cancer
HPV-Related Squamous Cell Carcinoma
Keywords: HPV-related oropharyngeal cancer
oropharyngeal cancer
HPV-related squamous cell carcinoma
prophylactic gabapentin
Optima II study
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants receiving radiation therapy as part of the OPTIMA II trial (NCT03107182) will be randomized to receive prophylactic gabapentin plus best supportive care versus best supportive care alone.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of opioid use at end of radiation treatment
timeFrame: 5 days
Secondary outcomes:
measure: Total opioid dosage during radiation treatment
timeFrame: 5 days
measure: Differences in head and neck symptoms
timeFrame: 24 months
measure: Differences in overall quality of life
timeFrame: 24 months
measure: Differences in chemotherapy-induced peripheral neuropathy symptoms
timeFrame: 24 months
measure: Swallowing Function
timeFrame: 12 weeks
measure: Feeding Tube Dependence
timeFrame: 24 months
measure: Treatment Delays
timeFrame: 7 weeks
measure: Side Effects
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Daniel Haraf, MD
role: PRINCIPAL_INVESTIGATOR
References: