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Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer

Primary Purpose

Oropharynx Cancer

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Gabapentin

Placebo Oral Capsule

About this trial

This is an interventional supportive care trial for Oropharynx Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Arm

Experimental Arm

Arm Description

Standard supportive care during definitive treatment plus placebo

Gabapentin plus standard supportive care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Average Opioid Use, Measured in Morphine Equivalents Per Day.

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).

Percent Weight Lost

Percent weight lost from baseline to week 7 of treatment (end of treatment)

Feeding Tube Placement

Measure of number of patients who required feeding tube placement at any time during the study period

Full Information

NCT ID

NCT03269344

First Posted

June 5, 2017

Last Updated

January 19, 2022

Sponsor

Henry Ford Health System

1. Study Identification

Unique Protocol Identification Number

NCT03269344

Brief Title

Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 5, 2017 (Actual)

Primary Completion Date

December 9, 2020 (Actual)

Study Completion Date

December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oropharynx Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Arm

Arm Type

Placebo Comparator

Arm Description

Standard supportive care during definitive treatment plus placebo

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

Gabapentin plus standard supportive care

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Capsule

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up

Description

Scale tile: Patient Reported Oral Mucositis Symptoms scale, range 0-1000, higher scores indicate worse outcomes

Time Frame

Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks

Secondary Outcome Measure Information:

Title

Change in Total FACT-HN Scores From Baseline to Follow-up

Description

Scale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes

Time Frame

Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks

Title

Average Opioid Use, Measured in Morphine Equivalents Per Day.

Time Frame

Over the entire study period from baseline to follow-up, approximately 13 weeks

Title

Change in PRO-CTCAE Scores From Baseline to Follow-up

Description

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).

Time Frame

Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks

Title

Percent Weight Lost

Description

Percent weight lost from baseline to week 7 of treatment (end of treatment)

Time Frame

Percent change from baseline to week 7 of treatment

Title

Feeding Tube Placement

Description

Measure of number of patients who required feeding tube placement at any time during the study period

Time Frame

Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farzan Siddiqui, MD PhD

Organizational Affiliation

Henry Ford Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34808255

Citation

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.

Results Reference

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Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer

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