Head and Neck Cancer Clinical Trial
Official title:
Chlorhexidine Gel Therapy for Cariogenic Oral Microflora in Irradiated Head and Neck Cancer Patients
The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable to patients will also be studied.
1% chlorhexidine gluconate gel is an alcohol-free, raspberry-flavored brush-on gel. It is
designed to decrease the amount of bacteria found in your mouth that can cause tooth decay.
Within a month, if you are found to be eligible to take part in this study, researchers will
use custom dental trays designed for you, in order to deliver the chlorhexidine gel. During
your next visit to the dental clinic, researchers will place these custom dental trays and
the gel in your mouth for about 5 minutes. Over the next 30 minutes, the gel will be applied
one more time. The dentist will also chart your decayed, missing, and filled teeth in a
dentist chart during this visit. The dentist will also check the soft tissues of your mouth.
You will have an office visit the next day (Day 2) to see if you had any side effects to the
chlorhexidine gel.
These trays will be coated with the gel every 2 weeks, for a 12-week period. You will hold
the trays with the gel in your mouth for at least 5 minutes, usually at night or in the
morning. You should not eat or drink during these 5 minutes in order to increase the
effectiveness of the gel on your teeth. You will apply the gel at home, for one 5-minute
application, on Weeks 2, 4, 8 and 10. You will be given a diary to list each time that you
use the gel at home, and to list if you experience any side effects. You will have office
visits on Weeks 6 and 12. The dentist will floss between all of your teeth during these
office visits. You will also use the gel, for two 5-minute applications, during these office
visits. You will also need to bring the completed diary to each office visit.
When you return for the office visit, a dentist or dental hygienist will then collect a
sample of your dental plaque (a film of mucous and bacteria found on your teeth's surface)
by scraping plaque from the surface of your teeth and flossing between your teeth, and then
placing the plaque in a small test tube to check for bacteria. The dentist will not scrape
below the gums. These plaque samples will be collected on Weeks 6 and 12 at the dental
clinic.
Once the gel application period is over, you will need to return to the dental clinic for
plaque sample scrapings at Weeks 16 and 20 so that researchers can check to see if the
bacteria is growing again.
You will also complete two questionnaires during your baseline, Week 6, and Week 12 visits
to describe your experience with the use of the gel and your side effects from radiation
treatment.
Once your last plaque sample scraping has been collected on Week 20, your participation in
this study will be complete. The dentist or dental hygienist will floss between all of your
teeth and your decayed, missing, and filled teeth will be charted in a dentist chart during
the Week 20 office visit. You will be taken off study if intolerable side effects occur.
This is an investigational study. 1% chlorhexidine gluconate is not FDA approved or
commercially available. It has been authorized for use in research only. About 50 patients
will take part in this study. All will be enrolled at MD Anderson.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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 |