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MIT-001 for Oral Mucositis Prevention in Head and Neck Cancer Patients (MIT-001 Trial)

Phase 2

Recruiting

Research Sponsored by MitoImmune Therapeutics

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less

Histologically confirmed HNSCC (The American joint committee on cancer [AJCC] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first treatment to 2 months of safety follow-up period after ccrt completion

Awards & highlights

MIT-001 Trial Summary

This trial will test whether MIT-001 can prevent oral mucositis in patients with head and neck squamous cell carcinoma who are undergoing concurrent chemoradiotherapy.

Who is the study for?

This trial is for adults with a specific type of throat cancer (HNSCC) that hasn't been treated yet. They should be in good physical shape, not pregnant, and planning to get standard chemo with cisplatin and targeted radiation therapy. People can't join if they've had recent surgery for HNSCC, have active mouth sores, severe allergies to platinum drugs like cisplatin, or any other serious health issues.Check my eligibility

What is being tested?

The study tests MIT-001's ability to prevent mouth sores caused by chemoradiotherapy in throat cancer patients. Participants will receive one of three different doses of MIT-001 or a placebo alongside their standard cancer treatment regimen.See study design

What are the potential side effects?

Potential side effects are not specified but may include reactions related to the prevention or management of oral mucositis as well as typical side effects from concurrent chemoradiotherapy.

MIT-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can carry out all my usual activities without help.

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My cancer is in the mouth or throat and is either at an advanced stage or HPV-positive.

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I am scheduled for weekly cisplatin treatments for 5 to 7 weeks.

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I am scheduled for a specific radiation therapy for head and neck cancer, targeting over 30% of my mouth.

MIT-001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first treatment to 2 months of safety follow-up period after ccrt completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first treatment to 2 months of safety follow-up period after ccrt completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first treatment to 2 months of safety follow-up period after ccrt completion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of severe OM

Secondary outcome measures

Analgesic use for OM

Incidence of OM

Mouth pain and discomfort

+1 more

MIT-001 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 60 mgExperimental Treatment1 Intervention

MIT-001 60 mg

Group II: 40 mgExperimental Treatment1 Intervention

MIT-001 40 mg

Group III: 20 mgExperimental Treatment1 Intervention

MIT-001 20 mg

Group IV: PlaceboPlacebo Group1 Intervention

Matching placebo

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MitoImmune TherapeuticsLead Sponsor

2 Previous Clinical Trials

100 Total Patients Enrolled

Heeyeon KimStudy DirectorMitoImmune Therapeutics

Suyeong Kim, M.PharmStudy DirectorMitoImmune Therapeutics

Media Library

MIT-001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04651634 — Phase 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: 20 mg, 40 mg, 60 mg, Placebo

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: MIT-001 Highlights & Side Effects. Trial Name: NCT04651634 — Phase 2

MIT-001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04651634 — Phase 2

Frequently Asked Questions

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

How many participants have joined this clinical exploration?

"This trial requires 60 individuals who meet the outlined criteria to partake in this experiment. Those wishing to enrol can do so at James P. Wilmot Cancer Center of Rochester, New york or University of Pittsburgh Medical Center - Hillman Cancer Center from Pennsylvania."

Answered by AI

Has the combination of MIT-001 and CCRT been sanctioned by the FDA?

"Our team assigned MIT-001 plus CCRT a score of 2 since this Phase 2 trial has some evidence in favour of its safety, yet there is no clinical data backing up its efficacy."

Answered by AI

Are there multiple research centers in this city conducting the study?

"At present, 8 distinct medical centres are hosting this trial. These sites can be found in Rochester, Pittsburgh, Gilbert and 5 other locations around the country. It would be beneficial to look up the clinic closest to you if enrolling in order to minimize any travel difficulties."

Answered by AI

Is this experiment currently looking for volunteers?

"Data hosted on clinicaltrials.gov suggests that this experiment is presently recruiting participants, its initial posting having been made 21st June 2021 and the most recent update occurring 27th January 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

2021. "MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04651634.

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