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

(MIT-001 Trial)

Recruiting at 15 trial locations

Overseen By Jinsang Jung

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MitoImmune Therapeutics

Must be taking: Cisplatin

Must not be taking: Cetuximab

Disqualifiers: Active mucositis, Metastatic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests MIT-001, a drug that reduces harmful molecules to prevent inflammation, in patients with advanced head and neck cancer undergoing chemoradiotherapy. The goal is to prevent painful mouth sores by protecting cells and blocking inflammation pathways.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you do not receive certain targeted or immune therapies during the study.

How is the drug MIT-001 different from other treatments for preventing oral mucositis in head and neck cancer patients?

The drug MIT-001 is unique because it may offer a novel approach to preventing oral mucositis, a common and painful side effect of cancer treatment, by potentially targeting the underlying mechanisms of the condition. While many existing treatments focus on supportive care, MIT-001 could represent a new preventive strategy, although specific details about its mechanism or components are not provided in the available research. ^{1 2 3 4 5}

Research Team

Jinsang Jung, M.Pharm

Principal Investigator

MitoImmune Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

I can carry out all my usual activities without help.

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

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

Exclusion Criteria

I currently have mouth sores.

I do not have any serious illnesses or infections that would stop me from joining the study.

I had surgery for head and neck cancer less than 4 weeks ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MIT-001 or placebo during concurrent chemoradiotherapy (CCRT) for HNSCC

6-8 weeks

Weekly visits (in-person) during CCRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Monthly visits (in-person)

Treatment Details

Interventions

• MIT-001

Trial Overview 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.

Participant Groups

Group I: 60 mg Experimental Treatment 1 Intervention

MIT-001 60 mg

Group II: 40 mg Experimental Treatment 1 Intervention

MIT-001 40 mg

Group III: 20 mg Experimental Treatment 1 Intervention

MIT-001 20 mg

Group IV: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

MitoImmune Therapeutics

Lead Sponsor

Trials

3

Recruited

160+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Alleviating mucositis: are we on track for a novel therapeutic? [2015]

4. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of interventions for preventing chemotherapy-induced oral mucositis in adult cancer patients: a systematic review and network meta-analysis. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Management of oral mucositis in patients with head and neck cancer receiving chemoradiotherapy and/or molecular targeted therapy]. [2011]