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

ConditionHead and Neck Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent signed and dated by the patient prior to the performance of the study-specific procedure.

At least 18 years-of-age at the time of signature of the informed consent form (ICF).

Patients with histologically proven HNSCC undergoing radiation of concurrent chemoradiation as part of their treatment plan.

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.

Disqualifiers

Inability to sign an informed consent form.

Any other malignancy diagnosed or treated within 10 years prior to enrollment.

Any documented hypersensitivity to ketamine.

Contraindication for ketamine use, including allergy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients who have altered pain response from mucositis in head and neck cancer undergoing radiation treatment from using ketamine oral rinse.

Review weekly questionnaires of patients who received ketamine oral rinse to assess if it helped with the pain of mucositis caused by the radiation in head and neck cancer patients.

Time frame
6 months

Secondary outcomes

1

Number of patients whose dysphagia was decreased by the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.

Dysphagia as assessed by MDADI.

Time frame
6 months.
2

Number of patients whose quality-of-life increased after the use of ketamine oral rinse among head and neck cancer patients undergoing radiation therapy.

Quality of life as assessed by FACT-HN.

Time frame
6 months
3

Number of patients who need morphine prescription equivalent reductions as a result of using ketamine oral rinse.

Pain medication requirement measured in morphine equivalents.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: