Oropharyngeal CancerPhase 2NCT03423264
PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing
A Phase 2 study testing Gabapentin in people with Oropharyngeal Cancer and HPV-Related Squamous Cell Carcinoma, run by University of Chicago at 1 site in United States.
Trial summary
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182). The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer, HPV-Related Squamous Cell Carcinoma
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 8 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment to OPTIMA II trial (NCT03107182)
Who cannot join
- Ineligible for enrollment to OPTIMA II trial (NCT03107182)
- Prior gabapentin therapy
- Creatinine clearance of < 45 mL/minute
- Documented intolerance, allergy, or hypersensitivity to gabapentin
- Hemodialysis or peritoneal dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Phase II Randomized Trial of Prophylactic Gabapentin Plus Best Supportive Care Versus Best Supportive Care Alone for Patients Receiving Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Locoregionally-Advanced, HPV-Related Oropharyngeal Cancer: An Optima II Secondary Study
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).
The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.
Read the detailed description
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).
Primary objective: To compare rates of opioid requirement as a function of supportive care in patients experiencing CTCAE grade ≥2 oral mucositis at completion of radiation or chemoradiation as part of OPTIMA II
Secondary objectives: To compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin. To investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol.
- Being tested
- Gabapentin
- Keywords
- HPV-related oropharyngeal cancer, oropharyngeal cancer, HPV-related squamous cell carcinoma, prophylactic gabapentin, Optima II study
- 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
Also called Neurontin
Gabapentin taken as follows:
Day 1 (evening): 600 mg Day 2 (morning): 600 mg Day 2 (evening): 600 mg Day 3 (morning): 600 mg Day 3 (evening): 900 mg Day 4 (morning): 900 mg Day 4 (evening): 900 mg Day 5 (morning): 900 mg Day 5 (noon): 900 mg Day 5 (evening): 900 mg
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Participants randomized to this arm will receive gabapentin beginning on evening of the first day of radiation treatment at a dose of 600 mg. Gabapentin will continue to be taken twice a day (morning and evening) for the next 4 days of radiation treatment at increasing doses (up to 900 mg). Participants will continue to receive standard best supportive care medications as per their treating physician's recommendation. Receives: Drug: Gabapentin |
| Supportive Care Only | No intervention | Participants will receive standard best supportive care medications as per their treating physician's recommendation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of opioid use at end of radiation treatment
Comparison of opioid use as part of best supportive care in patients with CTCAE grade ≥ 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.
Measured: 5 days
Secondary outcomes (8)
Total opioid dosage during radiation treatment
Comparison of total opioid dosage given as part of best supportive care in patients with CTCAE grade ≥ 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.
Measured: 5 days
Differences in head and neck symptoms
Measured by changes in patient reported head and neck specific symptoms
Measured: 24 months
Differences in overall quality of life
Measured by changes in patient reported symptoms
Measured: 24 months
Differences in chemotherapy-induced peripheral neuropathy symptoms
Measured by patient reported symptoms
Measured: 24 months
Swallowing Function
- Normal
- Within functional limits: abnormal oral or pharyngeal stage but able to eat regular diet; no modifications or swallowing precautions
- Mild impairment: mild dysfunction in oral or pharyngeal stage, requires modified diet; no therapeutic swallowing precautions
- Mild-moderate impairment: mild dysfunction in oral and pharyngeal stage, requires modified diet and therapeutic swallowing precautions
- Moderate impairment: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions
- Moderate-severe dysfunction: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions; requires primary enteral feeding support
- Severe impairment: severe dysfunction with significant aspiration or inadequate oropharyngeal transit to esophagus, NPO, requires primary enteral feeding support
Measured: 12 weeks
Feeding Tube Dependence
Assessment of rates of feeding tube dependence during and after radiation treatment
Measured: 24 months
Treatment Delays
Determine rate of unplanned radiation treatment delays.
Measured: 7 weeks
Side Effects
Determine rate of gabapentin related side effects as per CTCAE v4.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start22 Jan 2018
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: unable to accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants receiving radiation therapy as part of the OPTIMA II trial (NCT03107182) will be randomized to receive prophylactic gabapentin plus best supportive care versus best supportive care alone.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Haraf, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423264
- Sponsor's protocol ID
- IRB17-1550
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2018
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Prophylactic Gabapentin Plus Best Supportive Care Versus Best Supportive Care Alone for Patients Receiving Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Locoregionally-Advanced, HPV-Related Oropharyngeal Cancer: An Optima II Secondary Study
- ClinicalTrials.gov ID
- NCT03423264
- Acronym / sponsor ID
- IRB17-1550
- Keywords
- HPV-related oropharyngeal cancer, oropharyngeal cancer, HPV-related squamous cell carcinoma, prophylactic gabapentin, Optima II study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to accrue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).
The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.
Detailed description
Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).
Primary objective: To compare rates of opioid requirement as a function of supportive care in patients experiencing CTCAE grade ≥2 oral mucositis at completion of radiation or chemoradiation as part of OPTIMA II
Secondary objectives: To compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin. To investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants receiving radiation therapy as part of the OPTIMA II trial (NCT03107182) will be randomized to receive prophylactic gabapentin plus best supportive care versus best supportive care alone.
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinParticipants randomized to this arm will receive gabapentin beginning on evening of the first day of radiation treatment at a dose of 600 mg. Gabapentin will continue to be taken twice a day (morning and evening) for the next 4 days of radiation treatment at increasing doses (up to 900 mg). Participants will continue to receive standard best supportive care medications as per their treating physician's recommendation. |
| Supportive Care Only | No intervention | –Participants will receive standard best supportive care medications as per their treating physician's recommendation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrollment to OPTIMA II trial (NCT03107182)
Key exclusion criteria (5 listed)
- Ineligible for enrollment to OPTIMA II trial (NCT03107182)
- Prior gabapentin therapy
- Creatinine clearance of < 45 mL/minute
- Documented intolerance, allergy, or hypersensitivity to gabapentin
- Hemodialysis or peritoneal dialysis
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 |
|---|---|---|
| GabapentinAlso: NeurontinGabapentin taken as follows: Day 1 (evening): 600 mg Day 2 (morning): 600 mg Day 2 (evening): 600 mg Day 3 (morning): 600 mg Day 3 (evening): 900 mg Day 4 (morning): 900 mg Day 4 (evening): 900 mg Day 5 (morning): 900 mg Day 5 (noon): 900 mg Day 5 (evening): 900 mg | Drug | Gabapentin |
Primary outcome
Rate of opioid use at end of radiation treatment
Time frame: 5 days
Comparison of opioid use as part of best supportive care in patients with CTCAE grade ≥ 2 oral mucositis at the end of radiation treatment given as part of OPTIMA II study.
8 secondary outcomes
Total opioid dosage during radiation treatment
Time frame: 5 days
Differences in head and neck symptoms
Time frame: 24 months
Differences in overall quality of life
Time frame: 24 months
Differences in chemotherapy-induced peripheral neuropathy symptoms
Time frame: 24 months
Swallowing Function
Time frame: 12 weeks
Feeding Tube Dependence
Time frame: 24 months
Treatment Delays
Time frame: 7 weeks
Side Effects
Time frame: 13 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Related trials for Oropharyngeal Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
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.
Daniel Haraf, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin in people with Oropharyngeal Cancer and HPV-Related Squamous Cell Carcinoma, run by University of Chicago 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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 31 Jul 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of opioid use at end of radiation treatment (time frame: 5 days). 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 31 Jul 2024.