Malignant Head and Neck NeoplasmPhase 3NCT02480114
Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy
A Phase 3 study testing Educational Intervention, Gabapentin and Pain Therapy in people with Malignant Head and Neck Neoplasm and Mucositis, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Malignant Head and Neck Neoplasm, Mucositis, Radiation-Induced Disorder
- What is being tested?
- Educational Intervention, Gabapentin and Pain Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cancer of the head and neck cancer
- Stage 3 or 4
- Planned primary or adjuvant chemoradiation therapy
- Willing and able to provide informed consent
- English speaking
Who cannot join
- Currently on gabapentin
- Prior non-tolerance of gabapentin
- History of seizure disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
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.
Read the detailed description
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:
- To assess the safety (grade 3 or 4 adverse events) and tolerability of using gabapentin (discontinuation of drug due to side effects - yes or no)
- To correlate pain severity with frequency and severity of general systemic symptoms.
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.
- Being tested
- Educational Intervention, Gabapentin, Pain Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Abnormalities, Radiation-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention
Undergo oral care and pain management education session
GabapentinDrug
Also called Gralise, Neurontin, 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3,
Given PO
Pain TherapyOther
Also called Analgesia, Pain Control, Pain Management, Pain
Receive usual oral health care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Oxycodone/AcetaminophenDrug
Also called Percocet
Analgesia
Hydrocodone/AcetaminophenDrug
Also called Lortab, Vicodin
Analgesia
FentanylDrug
Also called Duragesic
Transdermal Analgesia
IbuprofenDrug
Also called Motrin, Advil
NSAID Analgesia
Magic MouthwashDrug
Also called Miracle Mouthwash, First-Mouthwash BLM, First-BXN Mouthwash
Oral Solution to treat mucositis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Pain Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Oxycodone/Acetaminophen; Drug: Hydrocodone/Acetaminophen; Drug: Fentanyl; Drug: Ibuprofen; Drug: Magic Mouthwash |
| 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. Receives: Other: Educational Intervention; Drug: Gabapentin; Other: Pain Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Oxycodone/Acetaminophen; Drug: Hydrocodone/Acetaminophen; Drug: Fentanyl; Drug: Ibuprofen; Drug: Magic Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months post-treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Head and Neck NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Derek Smith, Vanderbilt-Ingram Cancer Center
- Investigators
- Derek Smith, DDS,PhD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480114
- Sponsor's protocol ID
- VICC HN 1541
- Other IDs
- NCI-2015-00750, VICC HN 1541, P30CA068485
- Status last verified
- Jan 2021
- First submitted
- 16 Jun 2015
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
- ClinicalTrials.gov ID
- NCT02480114
- Acronym / sponsor ID
- VICC HN 1541
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2015
- Primary completion
- Sep 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To assess the safety (grade 3 or 4 adverse events) and tolerability of using gabapentin (discontinuation of drug due to side effects - yes or no)
- To correlate pain severity with frequency and severity of general systemic symptoms.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I Standard of Care | Active comparator | Other: Educational Intervention, Other: Pain Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Oxycodone/Acetaminophen, Drug: Hydrocodone/Acetaminophen, Drug: Fentanyl, Drug: Ibuprofen, Drug: Magic MouthwashPatients 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 | Other: Educational Intervention, Drug: Gabapentin, Other: Pain Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Oxycodone/Acetaminophen, Drug: Hydrocodone/Acetaminophen, Drug: Fentanyl, Drug: Ibuprofen, Drug: Magic MouthwashPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven cancer of the head and neck cancer
- Stage 3 or 4
- Planned primary or adjuvant chemoradiation therapy
- Willing and able to provide informed consent
- English speaking
Key exclusion criteria (3 listed)
- Currently on gabapentin
- Prior non-tolerance of gabapentin
- History of seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for InterventionUndergo oral care and pain management education session | Other | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| GabapentinAlso: Gralise, Neurontin, 1-(aminomethyl) cyclohexaneacetic Acid, 60142-96-3,Given PO | Drug | Arm II Standard of Care Plus Gabapentin |
| Pain TherapyAlso: Analgesia, Pain Control, Pain Management, PainReceive usual oral health care | Other | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| Questionnaire AdministrationAncillary studies | Other | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| Oxycodone/AcetaminophenAlso: PercocetAnalgesia | Drug | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| Hydrocodone/AcetaminophenAlso: Lortab, VicodinAnalgesia | Drug | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| FentanylAlso: DuragesicTransdermal Analgesia | Drug | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| IbuprofenAlso: Motrin, AdvilNSAID Analgesia | Drug | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
| Magic MouthwashAlso: Miracle Mouthwash, First-Mouthwash BLM, First-BXN MouthwashOral Solution to treat mucositis | Drug | Arm I Standard of Care, Arm II Standard of Care Plus Gabapentin |
Primary outcome
Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))
Time frame: Up to 3 months post-treatment
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.
2 secondary outcomes
Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)
Time frame: 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)
Time frame: Up to 3 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Smith, DDS,PhD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational Intervention, Gabapentin and Pain Therapy in people with Malignant Head and Neck Neoplasm and Mucositis, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS)) (time frame: Up to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.