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Trial Title:
Prevention of Oral Mucositis in Head and Neck Cancer.
NCT ID:
NCT05853692
Condition:
Oral Mucositis
Conditions: Official terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study will be conducted as a single-blind randomized clinical trial (RCT). The
population will be divided into two groups, receiving respectively the medical device and
a solution based on Sodium Bicarbonate (5 g/L)
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
The principal investigator will be encharged of generating the allocation sequence, of
enrolling the participants and of assigning the interventions to the participants.
The coworkers who will evaluate the onset of OM and its severity will be blinded about
the selected product.
Intervention:
Intervention type:
Device
Intervention name:
Zinc Gluconate
Description:
Three times a day (spray)
Arm group label:
Test
Intervention type:
Device
Intervention name:
Sodium Bicarbonate
Description:
Five times a day (rinse)
Arm group label:
Control
Summary:
Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous
membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an
acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.
Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the
prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain
symptoms and to accelerate the healing process of oral mucositis ulcerations.
The aim of this study is to demonstrate the efficacy of the treatment with Gel X to
reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary,
salivary glands, undergoing local radiotherapy for curative purpose
- Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary
glands, undergoing local radiotherapy as an adjuvant to surgical resection
- Patients able self-apply the product.
Exclusion Criteria:
- Patients with documented contraindication to any of the components of "Gel X" (there
included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40,
Hydrogenated castor oil, Pullulan, Flavors
- Patients with any neurological and psychiatric condition having an influence on the
ability to self-apply the treatment
- Patients participating to other clinical studies
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Catholic University of the Sacred Hearth
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carlo Lajolo, Prof.
Phone:
+393356078354
Email:
carlo.lajolo@unicatt.it
Start date:
October 10, 2022
Completion date:
June 10, 2026
Lead sponsor:
Agency:
Catholic University of the Sacred Heart
Agency class:
Other
Source:
Catholic University of the Sacred Heart
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05853692
