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Antiseptic

Laboratory Biomarker Analysis for Head and Neck Cancers

Phase 2

Waitlist Available

Led By Sun Yi

Research Sponsored by University of Arizona

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 up to 30 days post radiotherapy

Awards & highlights

Study Summary

This trial looks at whether chlorine dioxide sterilization can help reduce oral mucositis in patients with head and neck cancer who are undergoing radiotherapy.

Eligible Conditions

Head and Neck Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days post radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days post radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post radiotherapy 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 Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)

Secondary outcome measures

Duration of Severe OM (>= World Health Organization [WHO] Mucositis Scale Grade 3)

Patient Reported Outcomes as Measured by the Oral Mucositis Weekly Questionnaire (OMWQ)

Rates of Radiotherapy Interruption

+1 more

Other outcome measures

Oral Microbiome

Salivary TNFalpha, IL-1beta, and IL-6 Levels

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (chlorine dioxide sterilization)Experimental Treatment2 Interventions

Patients receive chlorine dioxide sterilization oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.

Group II: Arm II (placebo)Placebo Group2 Interventions

Patients receive placebo oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,653 Total Patients Enrolled

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,257 Total Patients Enrolled

Sun YiPrincipal InvestigatorThe University of Arizona Medical Center-University Campus

Frequently Asked Questions

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

Are there any further investigations into Laboratory Biomarker Analysis?

"Presently, there is 1 open investigation for Laboratory Biomarker Analysis and none of these trials have reached phase 3. Most studies surrounding this topic are based in Tucson, Arizona but other locations may be running related experiments."

Answered by AI

How many people are enrolled in this experiment?

"Indeed, the clinicaltrials.gov website affirms that this medical research is recruiting individuals at present. This investigation was initially posted on February 14th 2019 and has been newly updated as of June 14th 2022; it looks to enlist 20 people across a single location."

Answered by AI

To what degree can Laboratory Biomarker Analysis put individuals at risk?

"Data collected from Phase 2 trials indicates that Laboratory Biomarker Analysis is reasonably safe, and so it earned a score of 2."

Answered by AI

Is it still possible to join this research experiment?

"Affirmative. According to clinicaltrials.gov, this medical study has been actively recruiting since February 14th 2019 and the most recent modifications were made on June 14th 2022. 20 individuals are being sought at one particular centre for involvement in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy

2019. "Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03602066.