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

Primary Purpose

Oropharyngeal Cancer, HPV-Related Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oropharyngeal Cancer focused on measuring HPV-related oropharyngeal cancer, oropharyngeal cancer, HPV-related squamous cell carcinoma, prophylactic gabapentin, Optima II study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Chicago Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gabapentin

Supportive Care Only

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Differences in head and neck symptoms
Measured by changes in patient reported head and neck specific symptoms
Differences in overall quality of life
Measured by changes in patient reported symptoms
Differences in chemotherapy-induced peripheral neuropathy symptoms
Measured by patient reported symptoms
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
Feeding Tube Dependence
Assessment of rates of feeding tube dependence during and after radiation treatment
Treatment Delays
Determine rate of unplanned radiation treatment delays.
Side Effects
Determine rate of gabapentin related side effects as per CTCAE v4.

Full Information

First Posted
January 26, 2018
Last Updated
April 26, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03423264
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer, HPV-Related Squamous Cell Carcinoma
Keywords
HPV-related oropharyngeal cancer, oropharyngeal cancer, HPV-related squamous cell carcinoma, prophylactic gabapentin, Optima II study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm 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.
Arm Title
Supportive Care Only
Arm Type
No Intervention
Arm Description
Participants will receive standard best supportive care medications as per their treating physician's recommendation.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of opioid use at end of radiation treatment
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Total opioid dosage during radiation treatment
Description
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.
Time Frame
5 days
Title
Differences in head and neck symptoms
Description
Measured by changes in patient reported head and neck specific symptoms
Time Frame
24 months
Title
Differences in overall quality of life
Description
Measured by changes in patient reported symptoms
Time Frame
24 months
Title
Differences in chemotherapy-induced peripheral neuropathy symptoms
Description
Measured by patient reported symptoms
Time Frame
24 months
Title
Swallowing Function
Description
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
Time Frame
12 weeks
Title
Feeding Tube Dependence
Description
Assessment of rates of feeding tube dependence during and after radiation treatment
Time Frame
24 months
Title
Treatment Delays
Description
Determine rate of unplanned radiation treatment delays.
Time Frame
7 weeks
Title
Side Effects
Description
Determine rate of gabapentin related side effects as per CTCAE v4.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Haraf, MD
Phone
(773) 702-5976
Email
dharaf@radonc.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Haraf, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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