Oropharynx CancerPhase 3NCT03269344
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
A Phase 3 study testing Gabapentin in people with Oropharynx Cancer, run by Henry Ford Health System at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 9 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
- Age ≥ 18.
- ECOG performance status ≤ 1.
- Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.
Who cannot join
- Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
- Patients with metastatic disease are excluded from this clinical trial.
- Patient with allergies or hypersensitivity to gabapentin.
- Patients receiving surgery as part of their definitive management.
- Patients who have received prior chemotherapy or radiation therapy.
- Patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily.
- Uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma
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.
Read the detailed description
The specific aims of this proposed study include the following:
- Evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage III or IV oropharyngeal squamous cell carcinoma undergoing definitive radiation with concurrent chemotherapy as part of their cancer management, compared to standard supportive side effect mitigation - using patient reported quality of life endpoints such as the Patient-Reported Oral Mucositis Symptoms (PROMS) scale.
- Assess morphine-equivalent opioid use in both treatment arms by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation during radiation treatment.
- Report on change in Speech and swallow performance, as measured by the Performance Status Scale (PSS) for Head and Neck Cancer Patients
- Evaluate changes in weight from baseline throughout treatment between the two arms.
- Assess feeding tube requirements during treatment.
- Evaluate the adverse events associated with gabapentin.
- Evaluate the severity of radiation mucositis (grade 3-4, CTCAE, v. 4)
- Conditions
- Oropharynx Cancer
- Being tested
- Gabapentin, Placebo Oral Capsule
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
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
Placebo Oral CapsuleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Standard supportive care during definitive treatment plus placebo Receives: Drug: Placebo Oral Capsule |
| Experimental Arm | Experimental | Gabapentin plus standard supportive care Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
Secondary outcomes (5)
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
Measured: Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks
Average Opioid Use, Measured in Morphine Equivalents Per Day.
Measured: 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).
Measured: 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)
Measured: 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
Measured: Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start5 Jun 2017
- Primary completion9 Dec 2020
- Study completion9 Dec 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Cook, Henry Ford Health System
- Investigators
- Farzan Siddiqui, MD PhD, Study chair, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269344
- Sponsor's protocol ID
- HFHS-Gabapentin/RT Study
- Status last verified
- Jan 2022
- First submitted
- 5 Jun 2017
- Last updated
- 26 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34808255
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03269344
- Acronym / sponsor ID
- HFHS-Gabapentin/RT Study
- Conditions
- Oropharynx Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Posted 20 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific aims of this proposed study include the following:
- Evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage III or IV oropharyngeal squamous cell carcinoma undergoing definitive radiation with concurrent chemotherapy as part of their cancer management, compared to standard supportive side effect mitigation - using patient reported quality of life endpoints such as the Patient-Reported Oral Mucositis Symptoms (PROMS) scale.
- Assess morphine-equivalent opioid use in both treatment arms by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation during radiation treatment.
- Report on change in Speech and swallow performance, as measured by the Performance Status Scale (PSS) for Head and Neck Cancer Patients
- Evaluate changes in weight from baseline throughout treatment between the two arms.
- Assess feeding tube requirements during treatment.
- Evaluate the adverse events associated with gabapentin.
- Evaluate the severity of radiation mucositis (grade 3-4, CTCAE, v. 4)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: Placebo Oral CapsuleStandard supportive care during definitive treatment plus placebo |
| Experimental Arm | Experimental | Drug: GabapentinGabapentin plus standard supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage III-IV) squamous cell carcinoma of the oropharynx.
- Age ≥ 18.
- ECOG performance status ≤ 1.
- Patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires.
Key exclusion criteria (7 listed)
- Patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants.
- Patients with metastatic disease are excluded from this clinical trial.
- Patient with allergies or hypersensitivity to gabapentin.
- Patients receiving surgery as part of their definitive management.
- Patients who have received prior chemotherapy or radiation therapy.
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 |
|---|---|---|
| GabapentinGabapentin 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 | Drug | Experimental Arm |
| Placebo Oral CapsulePlacebo | Drug | Control Arm |
Primary outcome
Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up
Time frame: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes
5 secondary outcomes
Change in Total FACT-HN Scores From Baseline to Follow-up
Time frame: Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks
Average Opioid Use, Measured in Morphine Equivalents Per Day.
Time frame: Over the entire study period from baseline to follow-up, approximately 13 weeks
Change in PRO-CTCAE Scores From Baseline to Follow-up
Time frame: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks
Percent Weight Lost
Time frame: Percent change from baseline to week 7 of treatment
Feeding Tube Placement
Time frame: Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34808255Cook 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.
- Individual participant dataSharing planned: No
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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.
Farzan Siddiqui, MD PhD study chair
Henry Ford Hospital
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 Gabapentin in people with Oropharynx Cancer, run by Henry Ford Health System 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 4 inclusion and 7 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 26 Jan 2022. 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. Some participants in this study may receive a placebo. 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 20 Jan 2022). 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 Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up (time frame: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269344, which also lists 1 linked publication.
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 26 Jan 2022.