Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
Who is this study for? Patients with Head and Neck Cancer
What treatments are being studied? Gabapentin+Ketamine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• Histologically proven cancer of the head and neck cancer
• Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)
• Planned primary or adjuvant radiation or chemoradiation therapy
• Willing and able to provide informed consent
• ECOG PS 0-2
• Age ≥ 21 years
• English speaking
Locations
United States
Tennessee
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Contact Information
Primary
Vanderbilt-Ingram Service for Timely Access
cip@vumc.org
800-811-8480
Time Frame
Start Date: 2022-01-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 64
Treatments
Experimental: Gabapentin plus Ketamine
Gabapentin and Ketamine will be taken 3 times per day.
Authors
Related Therapeutic Areas
Sponsors
Leads: Natalie Lockney