Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT06122636 |
Other study ID # |
22/2021 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 3, 2022 |
Est. completion date |
December 2024 |
Study information
Verified date |
November 2023 |
Source |
University of Barcelona |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study is a Clinical Trial and the main objective is to Evaluate the effects of probiotics
on oral complications induced by antineoplastic therapies in patients with head and neck
cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO)
Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), Faculty of
Medicine and Health Sciences Bellvitge campus during the period 2022- 2024.
Research question:
Is the use of probiotics compared to placebo effective in reducing oral complications
produced by antineoplastic therapies in patients with head and neck cancer attended in the
radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and the Dental
Hospital of the University of Barcelona, Faculty of Medicine and Health Sciences campus
Bellvitge during the period 2022- 2024?
Study population: Patients attended at the radiotherapy service of the Catalan Institute of
Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB),
(Master of Dentistry in Oncology and Immunocompromised Patients) diagnosed by histological
confirmation of head and neck cancer and treated in the last year.Intervention:
Patients who agree to participate in the study will be randomized to the intervention or
control group. Two visits will be made, the first as a baseline measurement and the second
after the end of the intervention. In the first visit they will be given the products either
probiotic or placebo, with presentation of a box with 10 sachets. The probiotics contain:
Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium
breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus. 1 x
10e10 Colony Forming Units (CFU). And the placebo composed of excipients. They are gluten
free. Each patient will be given 1 sachet dissolved in water, to take 2-3 minutes of
mouthfuls then swallow, after brushing, once a day, for 30 days.
Description:
Background: The side effects of antineoplastic therapies of the head and neck aggravate the
condition of patients resulting in a decrease in the quality of life. At oral level, they can
induce the appearance of certain alterations, this predisposes to an imbalance in the oral
microbiota, increasing the presence of acidogenic and cariogenic bacteria. In the oral cavity
probiotics are associated with a decrease in the colony forming unit (CFU) count of
cariogenic pathogens and inhibition of periodontal pathogens. In addition, they modulate the
inflammatory response (humoral and cellular). For this reason, they could be considered a
good alternative to modulate the oral microbiota in head and neck oncology patients.
Hypothesis: The use of probiotics due to the change of the oral microbiota is associated with
a beneficial effect against oral complications produced by radiotherapy, chemotherapy and
surgery in patients with head and neck cancer, so that probiotic users will have a greater
reduction in oral complications induced by cancer therapies compared to those who do not use
probiotics. Objectives: To evaluate the effects of probiotics on oral complications induced
by antineoplastic therapies in patients with head and neck cancer, attended at the
radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and the Dental
Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences
Bellvitge campus during the period 2022- 2024. Methodology: Randomized Clinical Trial during
the period 2022-2024. The identification of the population of interest will be patients
attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet
and at the Dental Hospital of the University of Barcelona (HOUB), in the Master of Dentistry
and in Oncology and Immunocompromised Patients. Data will be collected by electronic record,
clinical examination, microbiological and radiographic analysis of the participants. Expected
results: The use of probiotics is expected to provide a greater reduction in oral
complications induced by head and neck antineoplastic therapies. Statistical analysis:
Comparison of categorical variables chi-square test, numerical variables Student's test for
independent samples and paired samples or Mann-Whitney U test and Wilcoxon signed-rank test.
Relative risk with 95% confidence interval. An intention-to-treat analysis will be performed.