MIT-001 for Oral Mucositis Prevention in Head and Neck Cancer Patients
(MIT-001 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test whether MIT-001, an experimental treatment, can prevent oral mucositis, a painful mouth condition, in patients with head and neck cancer undergoing chemoradiotherapy. Researchers will compare three doses of MIT-001 against a placebo to determine the most effective option. Candidates include those who have not yet started treatment for advanced head and neck cancer and plan to receive specific radiation therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that MIT-001 is likely to be safe for humans?
Research has shown that MIT-001, a drug tested to prevent painful mouth sores in cancer patients, is generally safe. In studies involving patients with conditions like lymphoma or multiple myeloma, MIT-001 was well-tolerated. These studies reported only mild side effects, and most patients managed the treatment well.
MIT-001 blocks harmful molecules that cause inflammation, potentially reducing the painful sores some cancer treatments can cause. Overall, the available evidence suggests that MIT-001 is safe for patients, and further research will help confirm this.12345Why do researchers think this study treatment might be promising?
Most treatments for oral mucositis in head and neck cancer patients, like mouth rinses and pain relievers, focus on managing symptoms rather than preventing them. MIT-001 is unique because it aims to prevent oral mucositis from occurring in the first place. Researchers are excited about MIT-001 because it is being tested in different doses (20 mg, 40 mg, and 60 mg), which could potentially offer more tailored and effective prevention options. Unlike the standard approaches, MIT-001 might provide a proactive solution, reducing the discomfort and complications associated with this condition.
What evidence suggests that MIT-001 could be effective for preventing oral mucositis in head and neck cancer patients?
Research has shown that MIT-001 might help prevent painful mouth sores in patients receiving treatment for head and neck cancer. In studies with cancer patients, MIT-001 reduced inflammation by neutralizing harmful molecules. This decrease in inflammation can help stop mouth sores from developing. This trial tests MIT-001 at different doses (20 mg, 40 mg, and 60 mg) to find the most effective one. Early results suggest that MIT-001 could be a promising option for patients seeking to lessen the side effects of cancer therapy.12346
Who Is on the Research Team?
Jinsang Jung, M.Pharm
Principal Investigator
MitoImmune Therapeutics
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MIT-001 or placebo during concurrent chemoradiotherapy (CCRT) for HNSCC
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
MIT-001 60 mg
MIT-001 40 mg
MIT-001 20 mg
Matching placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
MitoImmune Therapeutics
Lead Sponsor
Citations
Evaluation of the Safety and Efficacy for Oral Mucositis ...
The current clinical study was designed to evaluate the safety, efficacy by prevention of OM and pharmacokinetics of MIT-001 in patients with lymphoma or ...
NCT05493800 | Evaluate the Safety and Efficacy for Oral ...
Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning ...
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withpower.com
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MIT-001 for Prevention of CCRT-Induced OM in HNSCC ...
The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy ...
Phase 2a Randomized Trial to Assess the Safety and ...
This phase 2a, multi-institutional trial was designed to assess the safety and feasibility of 3 schedules of a fixed concentration of RRx-001; a standard-of- ...
Pharmacokinetic and Safety Profiles of MIT-001, a Novel ...
MIT-001 is a novel ferroptosis inhibitor with therapeutic potential for oxidative stress-related diseases. This study aimed to evaluate the ...
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