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

NCT03423264 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB17-1550
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Cancer; HPV-Related Squamous Cell Carcinoma

Keywords

HPV-related oropharyngeal cancer; oropharyngeal cancer; HPV-related squamous cell carcinoma; prophylactic gabapentin; Optima II study

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (8)

• Total opioid dosage during radiation treatment

  5 days

• Differences in head and neck symptoms

  24 months

• Differences in overall quality of life

  24 months

• Differences in chemotherapy-induced peripheral neuropathy symptoms

  24 months

• Swallowing Function

  12 weeks

Study Arms (2)

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.

Drug: Gabapentin

Supportive Care Only

NO INTERVENTION

Participants will receive standard best supportive care medications as per their treating physician's recommendation.

Interventions

Gabapentin DRUG

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

Also known as: Neurontin

Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment to OPTIMA II trial (NCT03107182)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

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

Study Officials

• Daniel Haraf, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 6, 2018
• Study Start: January 22, 2018
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)