MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Status Active, not recruiting

Clinical Trial Summary

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.

Clinical Trial Description

The primary objective of this double-arm, single-blinded, Phase II randomized study is to compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy. Secondary objectives include comparing the time to OMDQ MTS Q2 > 2 between the two arms; estimating and comparing opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit; assessing and comparing changes in the remaining OMDQ questions longitudinally throughout study; evaluating and comparing the duration of symptom relief in those who experience any degree of oral mucositis; evaluating and comparing the frequency of delays in [chemotherapy and/or radiation] therapy throughout the study period; and summarizing and comparing the prevalence and grade of oral mucositis at each clinic visit. The safety objective is to summarize the rates of potential side effects related to each oral formulation. A total of 60 eligible subjects will be enrolled and randomized in a 1:1 fashion to one of the treatment arms. Subjects on the control arm (sodium bicarbonate) who experience severe mucositis will have the option to crossover to the Mucolox arm for an additional 7 ± 2 days or until day 29 ± 5 days, whichever is longer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03461354
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 9, 2018
Completion date	April 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05808920` - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Active, not recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT03997643` - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial	Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04700475` - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.	N/A
Withdrawn	`NCT04058145` - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma	Phase 2
Completed	`NCT02572869` - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting	`NCT04474470` - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer	Phase 1/Phase 2
Withdrawn	`NCT05073809` - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Active, not recruiting	`NCT03651570` - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study	N/A
Recruiting	`NCT04930432` - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06016699` - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated	`NCT03843554` - Commensal Oral Microbiota in Head and Neck Cancer	N/A
Recruiting	`NCT05915572` - Mulligan Technique on Shoulder Dysfunction	N/A
Completed	`NCT05897983` - Tens and Rocabado Exercises on TMJ Dysfunction	N/A
Not yet recruiting	`NCT06289049` - Heavy Strength Training in Head and Neck Cancer Survivors	Phase 2
Withdrawn	`NCT05263648` - Virtual Reality Software to Reduce Stress in Cancer Patients	N/A
Withdrawn	`NCT03238638` - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.