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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00750 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICC HN 1541 | Other Identifier | Vanderbilt University/Ingram Cancer Center | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial studies how well gabapentin plus standard of care work compares to standard of care without Gabapentin in preventing inflammation of the mucous membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and neck may cause a burn involving the inside of the mouth, throat, and nasal passages, resulting in pain. Gabapentin may help prevent (or minimize) pain associated with radiation-induced mucositis in patients with head and neck cancer.
Primary Objectives:
- To determine whether gabapentin used as a preventive measure during chemoradiation can reduce radiation-induced mucositis associated pain in head and neck cancer patients as measured by: 1) pain scores on the Vanderbilt Head and Neck Symptom Survey (VHNSS version 2.), and 2) analgesic use.
Secondary Objectives:
Exploratory Objectives:
- To determine whether pain control is associated with weight loss (in pounds) and duration of use of percutaneous endoscopic gastrostomy utilization (in days).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Standard of Care (usual care) - Patients receive consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of chemoradiation treatment to review foundations of oral care and pain management.
ARM II: Standard of Care plus Gabapentin - Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin orally (PO) three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides.
After completion of study treatment, patients are followed up monthly for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I Standard of Care | Active Comparator | Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. |
|
| Arm II Standard of Care Plus Gabapentin | Experimental | Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Undergo oral care and pain management education session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) | The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain. | Up to 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0) | Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Smith, DDS,PhD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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Participants were enrolled at Vanderbilt Medical Center in Nashville, TN from July 2015 to May 2019. 79 participants were recruited and 8 of those withdrew.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm II Standard of Care Plus Gabapentin | Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2019 | Aug 12, 2020 |
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| Gabapentin | Drug | Given PO |
|
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| Pain Therapy | Other | Receive usual oral health care |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Oxycodone/Acetaminophen | Drug | Analgesia |
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| Hydrocodone/Acetaminophen | Drug | Analgesia |
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| Fentanyl | Drug | Transdermal Analgesia |
|
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| Ibuprofen | Drug | NSAID Analgesia |
|
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| Magic Mouthwash | Drug | Oral Solution to treat mucositis |
|
|
| Up to 3 months post-treatment |
| Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form) | Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom. | Up to 3 months post-treatment |
| FG001 | Arm I Standard of Care | Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I Standard of Care | Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis |
| BG001 | Arm II Standard of Care Plus Gabapentin | Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) | The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain. | Longitudinal analysis was completed including all patients in both arms of the study. Although some patients stopped filling out surveys part way through the study and therefore are not marked as 'complete' in the patient flow section, the data they did provide was still used for analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 3 months post-treatment |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0) | Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome. | All patients in both arms were analyzed. Although some patients stopped filling out surveys part way through the study and therefore are not marked as 'complete' in the patient flow section, the data they did provide was still used for analysis. | Posted | Count of Participants | Participants | Up to 3 months post-treatment |
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| Secondary | Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form) | Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom. | Although some patients stopped filling out surveys part way through the study and therefore are not marked as 'complete' in the patient flow section, the data they did provide was still used for analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 3 months post-treatment |
|
Approximately 3 months after completion of treatment
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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 | Arm I Standard of Care | Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis | 0 | 38 | 0 | 38 | 0 | 38 |
| EG001 | Arm II Standard of Care Plus Gabapentin | Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis | 0 | 41 | 0 | 41 | 2 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE criteria 4.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Derek Smith, DDS, PhD | Vanderbilt University Medical Center | 6159367423 | derek.k.smith@vumc.org |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2017 | Aug 12, 2020 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D052016 | Mucositis |
| D000016 | Abnormalities, Radiation-Induced |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D000077206 | Gabapentin |
| C018883 | cyclohexaneacetic acid |
| D000698 | Analgesia |
| D059408 | Pain Management |
| C514822 | oxycodone-acetaminophen |
| C083640 | acetaminophen, hydrocodone drug combination |
| D005283 | Fentanyl |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| 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 |
| D000760 | Anesthesia and Analgesia |
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010666 | Phenylpropionates |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis |
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| OG001 | Arm II Standard of Care Plus Gabapentin | Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis |
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