Trial Outcomes & Findings for Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer (NCT NCT03269344)
NCT ID: NCT03269344
Last Updated: 2022-01-26
Results Overview
Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
Results posted on
2022-01-26
Participant Flow
After 65 patients were enrolled, 7 more were excluded from analysis, leaving 58 patients analyzed. These patients were excluded because they received immunotherapy (n=1), pursued treatment elsewhere (n=2), developed acute kidney injury (n=1), and refused to take medication during the first two weeks of treatment (n=3).
Participant milestones
| Measure |
Control Arm
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Control Arm
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
3
|
Baseline Characteristics
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
60.2 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Smoking Status
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Primary Site
Oropharynx-base of tongue
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Primary Site
Oropharynx-soft palate
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Primary Site
Oropharynx-tonsil
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Primary Site
Oropharynx-vallecula
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Primary Site
Oropharynx-not specified
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Primary Site
Unknown primary
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
HPV Status
Negative
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
HPV Status
Positive
|
23 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
HPV Status
Unknown
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Clinical T Stage
1
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Clinical T Stage
2
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Clinical T Stage
3
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Clinical T Stage
4
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Clinical T Stage
4a
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Clinical T Stage
4b
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Clinical T Stage
Tx or T0
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Clinical N Stage
0
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Clinical N Stage
1
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Clinical N Stage
2
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Clinical N Stage
2a
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Clinical N Stage
2b
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Clinical N Stage
2c
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Clinical N Stage
3
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Type of Chemotherapy
Carboplatin-based
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Type of Chemotherapy
Cisplatin every 3 weeks
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Type of Chemotherapy
Cisplatin weekly
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Opioid Use at Baseline
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Gross Tumor Volume of Primary Tumor
|
22.0 cubic centimeter (cc)
STANDARD_DEVIATION 17.2 • n=93 Participants
|
21.5 cubic centimeter (cc)
STANDARD_DEVIATION 18.5 • n=4 Participants
|
21.8 cubic centimeter (cc)
STANDARD_DEVIATION 17.9 • n=27 Participants
|
|
Gross Tumor Volume Total (cc)
|
50.3 cc
STANDARD_DEVIATION 40.8 • n=93 Participants
|
49.2 cc
STANDARD_DEVIATION 31.5 • n=4 Participants
|
49.8 cc
STANDARD_DEVIATION 36.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeksScale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up
|
20.1 score on a scale
Standard Deviation 16.8
|
29.1 score on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeksScale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes
Outcome measures
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Change in Total FACT-HN Scores From Baseline to Follow-up
|
-15.0 units on a scale
Interval -19.5 to -2.5
|
-20.0 units on a scale
Interval -25.8 to -11.8
|
SECONDARY outcome
Timeframe: Over the entire study period from baseline to follow-up, approximately 13 weeksOutcome measures
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Average Opioid Use, Measured in Morphine Equivalents Per Day.
|
15.6 Daily morphine equivalents
Interval 6.7 to 32.2
|
22.2 Daily morphine equivalents
Interval 13.3 to 35.0
|
SECONDARY outcome
Timeframe: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeksScale: Patient-reported outcomes of Common Terminology Criteria for Adverse Events (PRO-CTCAE), 5-point Likert scale, higher scores indicate worse outcomes. Range of scores 0-40 (min-max).
Outcome measures
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Change in PRO-CTCAE Scores From Baseline to Follow-up
|
1.0 units on a scale
Interval -2.0 to 6.0
|
6.5 units on a scale
Interval 3.5 to 11.8
|
SECONDARY outcome
Timeframe: Percent change from baseline to week 7 of treatmentPercent weight lost from baseline to week 7 of treatment (end of treatment)
Outcome measures
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Percent Weight Lost
|
-10.7 Percent change
Interval -14.4 to -7.8
|
-11.4 Percent change
Interval -15.6 to -8.0
|
SECONDARY outcome
Timeframe: Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeksMeasure of number of patients who required feeding tube placement at any time during the study period
Outcome measures
| Measure |
Control Arm
n=29 Participants
Standard supportive care during definitive treatment plus placebo
Placebo Oral Capsule: Placebo
|
Experimental Arm
n=29 Participants
Gabapentin plus standard supportive care
Gabapentin: Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
|
|---|---|---|
|
Feeding Tube Placement
|
6 Participants
|
18 Participants
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place