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Ketamine Mouthwash for Oral Mucositis

Phase 2

Waitlist Available

Led By Bhupesh Parashar, MD, DrPH

Research Sponsored by Bhupesh Parashar, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up categorical (yes/no) measurement at any time after start of ketamine therapy and prior to completion of cancer-directed therapy, i.e. the time of completion of 35 fractions of radiation therapy, which may occur later than completion of the trial protocol

Awards & highlights

Study Summary

This trial is testing whether ketamine mouthwash can help reduce pain and the need for opioids in people with head and neck cancer.

Who is the study for?

This trial is for adults aged 18-70 with certain types of head and neck cancer experiencing severe pain after starting radiation therapy. They must be on a curative radiotherapy plan with cisplatin-based chemotherapy, have at least two weeks left in treatment, and not have other recent cancers or conditions that could interfere with ketamine use.Check my eligibility

What is being tested?

The trial tests if a ketamine mouthwash can reduce pain and opioid need in patients undergoing standard chemoradiotherapy for head and neck cancer. Over two weeks, the effects on pain levels, opioid consumption, treatment interruptions, and overall quality of life will be measured.See study design

What are the potential side effects?

Ketamine mouthwash has so far shown no significant side effects when used locally in the mouth to manage pain. It avoids systemic side effects typically associated with full-body administration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ categorical (yes/no) measurement at any time after start of ketamine therapy and prior to completion of cancer-directed therapy, i.e. the time of completion of 35 fractions of radiation therapy, which may occur later than completion of the trial protocol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~categorical (yes/no) measurement at any time after start of ketamine therapy and prior to completion of cancer-directed therapy, i.e. the time of completion of 35 fractions of radiation therapy, which may occur later than completion of the trial protocol

This trial's timeline: 3 weeks for screening, Varies for treatment, and categorical (yes/no) measurement at any time after start of ketamine therapy and prior to completion of cancer-directed therapy, i.e. the time of completion of 35 fractions of radiation therapy, which may occur later than completion of the trial protocol for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing Pain Response

Secondary outcome measures

Adverse events

Assessing Dysphagia

Assessing Patient-reported pain score

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketamine MouthwashExperimental Treatment1 Intervention

Enrolled patients with histologically confirmed squamous cell carcinoma of the head and neck undergoing definitive radiation therapy to 70Gy with concurrent cisplatin chemotherapy who develop grade 3+ toxicity will be prescribed ketamine mouthwash at a strength of 20mg/5mL in NovaFilm suspension with OraSweet flavoring agent via "swish and spit" route of administration. They will take the investigational drug four times daily.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Bhupesh Parashar, MDLead Sponsor

1 Previous Clinical Trials

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,933 Total Patients Enrolled

1 Trials studying Pharyngitis

168 Patients Enrolled for Pharyngitis

Bhupesh Parashar, MD, DrPHPrincipal InvestigatorNorthwell Health

Media Library

Ketamine Mouthwash Clinical Trial Eligibility Overview. Trial Name: NCT05331131 — Phase 2

Pharyngitis Research Study Groups: Ketamine Mouthwash

Pharyngitis Clinical Trial 2023: Ketamine Mouthwash Highlights & Side Effects. Trial Name: NCT05331131 — Phase 2

Ketamine Mouthwash 2023 Treatment Timeline for Medical Study. Trial Name: NCT05331131 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research team accept volunteers aged 55 or older for this investigation?

"This clinical trial is open to all individuals who are over the age of majority and below 70 years old."

Answered by AI

Could I potentially be accepted as a participant in this medical experiment?

"This research study seeks 56 volunteers between 18 and 70 years of age with signs of mucositis. To be eligible for the trial, these criteria must be met."

Answered by AI

Does the FDA recognize Ketamine Mouthwash as a viable treatment option?

"After a comprehensive assessment, the safety of Ketamine Mouthwash was appraised at 2. This is because while there are existing studies that support its safety, evidence confirming its efficacy has yet to be collected."

Answered by AI

Are there still opportunities to participate in the trial?

"Per clinicaltrials.gov, this investigation has already finished the patient recruitment process. Initially published on January 1st 2023, it was last adjusted on November 1st 2022 and is no longer recruiting participants for trial participation. Nevertheless, there are still 441 other medical studies actively looking for volunteers at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial

Bhupesh Parashar, MD 2022. "Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05331131.