Head and Neck Cancer Clinical Trial
Official title:
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.
Radiation-induced xerostomia and hyposalivation are frequent side effects after completed
treatment for oral and oropharyngeal cancers. This may induce eating and swallowing
difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a
consequence, quality of life is often impaired for this group of patients even after
completing treatment.
This study hypothesize that chewing gum can stimulate salivary flow from the residual
functional salivary glands and thereby improving the patient's oral well-being.
Primary endpoint:
- To assess whether the difference between the unstimulated and stimulated salivary flow
after a one-month period of using chewing gum will result in improved oral well-being.
Secondary endpoint:
- To assess if unstimulated and stimulated salivary flow differs between the two groups of
patients
- To evaluate changes in quality of life with EORTC QLQ H&N-35 for patients using chewing
gum
- To evaluate differences in quality of life with EORTC QLQ H&N-35 between the two groups
of patients.
All patients who have received curative intended treatment for oral or oropharyngeal
carcinomas at the Department of Oncology, Odense University Hospital, will be invited to
participate in the study. If the eligibility criteria are met the patient will be randomized
2:1 to either the intervention arm with chewing gum or the control arm with standard oral
care. The study intends to include 210 patients in total. Of these, 140 patients in the
intervention arm and 70 in the control arm. Recruitment to the study was initiated in
September 2016 and is expected to be completed in July 2018.
The duration of the study is one month from inclusion and randomization to final follow up.
For all included patients, saliva samples are collected (unstimulated and stimulated
sialometry) and the EORTC QLQ H&N-35 questionnaire and a xerostomia specific questionnaire
are completed. The patients in the control arm are only introduced to chewing gum at the last
follow up visit. In the intervention arm, all patients are instructed to use the chewing gum
on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document
compliance.
;
| 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 |