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Strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. The investigators hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance on opioid medication, and improve the quality of life for these patients.
The specific aims of this proposed study include the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Placebo Comparator | Standard supportive care during definitive treatment plus placebo |
|
| Experimental Arm | Experimental | Gabapentin plus standard supportive care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up | Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes | Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total FACT-HN Scores From Baseline to Follow-up | Scale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes | Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks |
| Average Opioid Use, Measured in Morphine Equivalents Per Day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farzan Siddiqui, MD PhD | Henry Ford Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34808255 | Derived | Cook A, Modh A, Ali H, Sheqwara J, Chang S, Ghanem T, Momin S, Wu V, Tam S, Money S, Han X, Fakhoury L, Movsas B, Siddiqui F. Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Prophylactic Gabapentin for the Reduction of Oral Mucositis Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2022 Mar 15;112(4):926-937. doi: 10.1016/j.ijrobp.2021.11.012. Epub 2021 Nov 20. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Standard supportive care during definitive treatment plus placebo Placebo Oral Capsule: Placebo |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Standard supportive care during definitive treatment plus placebo Placebo Oral Capsule: Placebo |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up | Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes | Posted | Mean | Standard Deviation | score on a scale | Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks |
|
Adverse effects data were collected from baseline, throughout the 7 week treatment course, and at the 6-week post-treatment follow-up timepoint. Thus, this time period was about 14 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Standard supportive care during definitive treatment plus placebo Placebo Oral Capsule: Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Cook | Henry Ford Cancer Institute | 3135568400 | acook11@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2017 | Nov 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo Oral Capsule | Drug | Placebo |
|
| Over the entire study period from baseline to follow-up, approximately 13 weeks |
| Change in PRO-CTCAE Scores From Baseline to Follow-up | Scale: 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). | Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks |
| Percent Weight Lost | Percent weight lost from baseline to week 7 of treatment (end of treatment) | Percent change from baseline to week 7 of treatment |
| Feeding Tube Placement | Measure of number of patients who required feeding tube placement at any time during the study period | Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoking Status | Stratification variable | Count of Participants | Participants |
|
| Primary Site | Count of Participants | Participants |
|
| HPV Status | Count of Participants | Participants |
|
| Clinical T Stage | Patients were staged according to the American Joint Committee on Cancer staging system 8th edition (2017) for oropharyngeal tumors. Higher numbers indicated higher stage/more advanced tumors. | Count of Participants | Participants |
|
| Clinical N Stage | Patients were staged according to the American Joint Committee on Cancer staging system 8th edition (2017) for oropharyngeal tumors. Higher numbers indicated higher stage/more advanced tumors. | Count of Participants | Participants |
|
| Type of Chemotherapy | Count of Participants | Participants |
|
| Opioid Use at Baseline | Count of Participants | Participants |
|
| Gross Tumor Volume of Primary Tumor | Mean | Standard Deviation | cubic centimeter (cc) |
|
| Gross Tumor Volume Total (cc) | Mean | Standard Deviation | cc |
|
|
|
|
| Secondary | Change in Total FACT-HN Scores From Baseline to Follow-up | Scale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes | Posted | Median | Inter-Quartile Range | units on a scale | Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks |
|
|
|
|
| Secondary | Average Opioid Use, Measured in Morphine Equivalents Per Day. | Posted | Median | Inter-Quartile Range | Daily morphine equivalents | Over the entire study period from baseline to follow-up, approximately 13 weeks |
|
|
|
|
| Secondary | Change in PRO-CTCAE Scores From Baseline to Follow-up | Scale: 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). | Posted | Median | Inter-Quartile Range | units on a scale | Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks |
|
|
|
|
| Secondary | Percent Weight Lost | Percent weight lost from baseline to week 7 of treatment (end of treatment) | Posted | Median | Inter-Quartile Range | Percent change | Percent change from baseline to week 7 of treatment |
|
|
|
|
| Secondary | Feeding Tube Placement | Measure of number of patients who required feeding tube placement at any time during the study period | Posted | Count of Participants | Participants | Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 29 | 0 | 29 | 0 | 29 |
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| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |