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PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423264
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief 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 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.


Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer HPV-Related Squamous Cell Carcinoma Drug: Gabapentin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
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.
Drug: Gabapentin

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

Other Name: Neurontin

No Intervention: Supportive Care Only
Participants will receive standard best supportive care medications as per their treating physician's recommendation.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total opioid dosage during radiation treatment [ Time Frame: 5 days ]
    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.

  2. Differences in head and neck symptoms [ Time Frame: 24 months ]
    Measured by changes in patient reported head and neck specific symptoms

  3. Differences in overall quality of life [ Time Frame: 24 months ]
    Measured by changes in patient reported symptoms

  4. Differences in chemotherapy-induced peripheral neuropathy symptoms [ Time Frame: 24 months ]
    Measured by patient reported symptoms

  5. Swallowing Function [ Time Frame: 12 weeks ]
    1. Normal
    2. Within functional limits: abnormal oral or pharyngeal stage but able to eat regular diet; no modifications or swallowing precautions
    3. Mild impairment: mild dysfunction in oral or pharyngeal stage, requires modified diet; no therapeutic swallowing precautions
    4. Mild-moderate impairment: mild dysfunction in oral and pharyngeal stage, requires modified diet and therapeutic swallowing precautions
    5. Moderate impairment: moderate dysfunction in oral or pharyngeal stage, aspiration noted on exam, requires modified diet and swallowing precautions
    6. 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
    7. Severe impairment: severe dysfunction with significant aspiration or inadequate oropharyngeal transit to esophagus, NPO, requires primary enteral feeding support

  6. Feeding Tube Dependence [ Time Frame: 24 months ]
    Assessment of rates of feeding tube dependence during and after radiation treatment

  7. Treatment Delays [ Time Frame: 7 weeks ]
    Determine rate of unplanned radiation treatment delays.

  8. Side Effects [ Time Frame: 13 weeks ]
    Determine rate of gabapentin related side effects as per CTCAE v4.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrollment to OPTIMA II trial (NCT03107182)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423264


Contacts
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Contact: Daniel Haraf, MD (773) 702-5976 dharaf@radonc.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Daniel Haraf, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03423264    
Other Study ID Numbers: IRB17-1550
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Chicago:
HPV-related oropharyngeal cancer
oropharyngeal cancer
HPV-related squamous cell carcinoma
prophylactic gabapentin
Optima II study
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents