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Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Pain, Stomatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Methadone Hydrochloride
Oxycodone Hydrochloride
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are eligible for chemoradiation therapy of the head and neck
  • Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal
  • Have a clinical stage II-IV head and neck carcinoma
  • Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Ability to swallow and retain oral medication or take through a feeding tube
  • Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer
  • Patients with known brain metastases will be excluded from this clinical trial
  • Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs
  • Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment
  • Patients on medications that prolong QT interval
  • Patients on dialysis or with transplanted organs
  • Patients already enrolled on other studies of systemic pain control agents

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (gabapentin)

Arm II (gabapentin, methadone, oxycodone)

Arm Description

Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).

Outcomes

Primary Outcome Measures

Change in pain levels via Oral Mucositis Daily Questionnaire (OMDQ), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30, Head and Neck Quality of Life Survey, and physical evaluations
Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Incidence of side effects or drug intolerance
Will be graded and recorded. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate. The frequency of toxicities will be tabulated by grade by treatment arm.
Proportion of patients who require higher equivalents of narcotic support added to their analgesia regimen in each arm
Each patient requiring rescue medication for breakthrough or refractory pain will be counted as a failure for that specific regimen. At the end of the trial, number of failures will be compared between the two treatment arms using Fisher's exact test. Total amount of opioid intake mean will be compared using a t-test between the two arms. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate

Secondary Outcome Measures

Change in oral mucositis rating scores during and after CRT, using the OMDQ
The total score of the OMDQ questionnaire will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Change in quality of life rating scores during and after CRT, using the EORTC QLQ-C30 and H&N35
The total score of the EORTC questionnaires will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.

Full Information

First Posted
August 19, 2015
Last Updated
July 20, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02531906
Brief Title
Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation
Official Title
Analysis of Analgesia Regimens During Concurrent Chemoradiation for Head and Neck Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2015 (undefined)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized pilot clinical trial studies the side effects of gabapentin and how well it works when given together with methadone hydrochloride and oxycodone hydrochloride in improving quality of life in patients with stage II-IV head and neck cancer during chemoradiation. Gabapentin, methadone hydrochloride, and oxycodone hydrochloride may help relieve moderate or severe pain caused by head and neck cancer during and after chemoradiation therapy.
Detailed Description
PRIMARY OBJECTIVES: I. Collect preliminary data on the safety and efficacy of two analgesic regimens that can be used to design larger studies for comparing such regimens. SECONDARY OBJECTIVES: I. Examine effects of the treatment regimens on pain control, oral mucositis, and quality-of-life ratings scores during and after chemoradiation therapy (CRT). TERTIARY OBJECTIVES: I. To assess treatment regimen effect on patient nutrition and hydration status during and after CRT (weight loss, vitals, oral [PO] tolerance, etc.). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive gabapentin PO thrice daily (TID) for up to 7 weeks during radiotherapy. ARM II: Patients receive gabapentin PO TID, methadone hydrochloride PO twice daily (BID), and oxycodone hydrochloride PO every 8 hours (Q8H) as needed (PRN) for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen). After completion of study, patients are followed up at 30 days, and at 3, 6, 9, and 12 months. Patients requiring prolonged analgesic therapy may be followed up every 6 months for 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Pain, Stomatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (gabapentin)
Arm Type
Experimental
Arm Description
Patients receive gabapentin PO TID for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
Arm Title
Arm II (gabapentin, methadone, oxycodone)
Arm Type
Experimental
Arm Description
Patients receive gabapentin PO TID, methadone hydrochloride PO BID, and oxycodone hydrochloride PO Q8H PRN for up to 7 weeks during radiotherapy. All patients may continue to receive treatment for pain throughout their course of chemoradiation therapy (and up to 24 months following CRT if continuing on a pain regimen).
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gralise, Neurontin
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Methadone Hydrochloride
Other Intervention Name(s)
Adanon, Althose, Dolophine, Methadose
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Oxycodone Hydrochloride
Other Intervention Name(s)
Oxecta, OxyContin, Roxicodone
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in pain levels via Oral Mucositis Daily Questionnaire (OMDQ), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30, Head and Neck Quality of Life Survey, and physical evaluations
Description
Evaluated using a repeated measures model. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Time Frame
Baseline to up to 24 months
Title
Incidence of side effects or drug intolerance
Description
Will be graded and recorded. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate. The frequency of toxicities will be tabulated by grade by treatment arm.
Time Frame
Up to 24 months
Title
Proportion of patients who require higher equivalents of narcotic support added to their analgesia regimen in each arm
Description
Each patient requiring rescue medication for breakthrough or refractory pain will be counted as a failure for that specific regimen. At the end of the trial, number of failures will be compared between the two treatment arms using Fisher's exact test. Total amount of opioid intake mean will be compared using a t-test between the two arms. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Change in oral mucositis rating scores during and after CRT, using the OMDQ
Description
The total score of the OMDQ questionnaire will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Time Frame
Baseline to up to 24 months
Title
Change in quality of life rating scores during and after CRT, using the EORTC QLQ-C30 and H&N35
Description
The total score of the EORTC questionnaires will be recorded after each follow-up visit. Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Time Frame
Baseline to up to 24 months
Other Pre-specified Outcome Measures:
Title
Change in patient hydration and nutrition using the OMDQ
Description
Tested using a two-sided 0.05 significance level. Post hoc analyses will be done with multiple comparisons adjusted for using the Bonferroni method. Assumptions of normality and equal variance will be examined, and transformations will be used as appropriate.
Time Frame
Baseline to up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are eligible for chemoradiation therapy of the head and neck Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal Have a clinical stage II-IV head and neck carcinoma Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Ability to swallow and retain oral medication or take through a feeding tube Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer Patients with known brain metastases will be excluded from this clinical trial Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or nursing female patients Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug Received an investigational agent within 30 days prior to enrollment Patients on medications that prolong QT interval Patients on dialysis or with transplanted organs Patients already enrolled on other studies of systemic pain control agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag Singh
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation

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