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

NCT03269344 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HFHS-Gabapentin/RT Study
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharynx Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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

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

• Average Opioid Use, Measured in Morphine Equivalents Per Day.

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

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

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

• Percent Weight Lost

  Percent change from baseline to week 7 of treatment

• Feeding Tube Placement

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

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

Standard supportive care during definitive treatment plus placebo

Drug: Placebo Oral Capsule

Experimental Arm

EXPERIMENTAL

Gabapentin plus standard supportive care

Drug: Gabapentin

Interventions

Gabapentin DRUG

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

Experimental Arm

Placebo Oral Capsule DRUG

Placebo

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 34808255 DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Andrew Cook
• Organization: Henry Ford Cancer Institute

acook11@hfhs.org

3135568400

Study Officials

• Farzan Siddiqui, MD PhD

  Henry Ford Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physcian

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: August 31, 2017
• Study Start: June 5, 2017
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: January 26, 2022
• Results First Posted: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)