Head and Neck Cancer Patients With Oral Mucositis Treated With Ketamine Oral Rinse

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06660017
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Patients in this arm will receive unmedicated syrup solution dispensed as 20mg/5ml 4 times a day in addition to receiving one of the following standard treatments; Magic Mouthwash, saliva substitute rinses, over-the-counter remedies including honey or salt and soda rinses, non-steroidal anti-inflammatory drugs (NSAIDS), or opioid medications.
  • Ketamine Topical — DRUG
    Patients in this arm will receive ketamine oral rinse dispensed as 20mg/5ml 4 times a day in addition to receiving one of the following standard treatments; Magic Mouthwash, saliva substitute rinses, over-the-counter remedies including honey or salt and soda rinses, non-steroidal anti-inflammatory drugs (NSAIDS), or opioid medications.

Study Details

This 2-arm phase II study proposes to determine the efficacy of ketamine oral rinse in pain relief from mucositis in head and neck cancer patients undergoing radiation treatment.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Group
    Topical unmedicated syrup base + any standard treatment for oral mucositis.
  • Experimental: Intervention Group
    Topical ketamine in syrup + any standard treatment for oral mucositis.

Primary Outcome Measure

Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73117
Lead Nurse
[email protected]
405-271-8777
Rusha Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oklahoma City, OK

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
OU Health Stephenson Cancer Center· Oklahoma City, OK

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