NCT05156060RecruitingPhase 1/2
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 30 Nov 2021
- Start date
- 24 Jan 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Natalie Lockney
- Diseases
- Head and neck cancer
- NCT number
- NCT05156060
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 64
- From 24 Jan 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on gabapentin or ketamine
- Prior non-tolerance of gabapentin or ketamine
Other illness
- History of seizure disorder
- History of schizophrenia
- History of increased intracranial pressure
Other
- Unable to administer ketamine intranasally due to anatomical restrictions
- Glomerular filtration rate \<30 mL/min/1.73 m2
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.