Quality of LifeHNCNCT06122636
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications in Patients With HNC
A study testing The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory in people with Quality of Life and Oral Mucositis, run by University of Barcelona at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Oral Mucositis, Dental Plaque
- What is being tested?
- The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 3 Oct 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Who give informed consent to participate in the study.
- With histologic diagnosis of head and neck cancer.
- Treated within the last year for head and neck cancer.
Who cannot join
- Patients who do not wish to participate in the study.
- Patients with osteonecrosis.
- Inability to take oral medications.
- Allergic to probiotics.
- On active antibiotic treatment or having received antibiotic treatment in the last thirty days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With Head and Neck Cancer: Randomized Clinical Study
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:
Read more
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.
Read the detailed 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.
- Conditions
- Quality of Life, Oral Mucositis, Dental Plaque, Periodontal Diseases, Xerostomia, Dysbiosis
- Being tested
- The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory, Placebo
- Keywords
- Radiotherapy, chemotherapy, surgery, probiotics, head and neck cancer
- Medical subject headings
- Stomatitis, Dental Plaque, Periodontal Diseases, Xerostomia, Dysbiosis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratoryDietary supplement
Each patient should take 1 sachet per day, dissolve it in a glass of water, hold in the mouth for 2-3 minutes and then swallow, for a period of 30 days.
PlaceboOther
The placebo will be administered in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | An envelope with the same packaging, size, shape and color will be given, it will only differ from the placebo in that it will contain the active ingredient of the intervention which is Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus.Experimental group Receives: Dietary Supplement: The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory |
| Placebo group | Placebo comparator | The placebo will be given in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of oral dysbiosis
Analyzed through microbiological qPCR study with 16 S sRNA primers, real-time quantitative PCR and comparative analysis with conventional culture looking for changes in the total count of the following periodontopathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Campylobacter rectus, Fusobacterium nucleatum and Candida culture.
Measured: 30 days
Rate of xerostomia
It will be measured by sialometry, analyzing unstimulated salivary secretion and stimulated salivary secretion
Measured: 30 days
Salivary ph concentration
It will be measured through paper strips, in one of the containers with accumulated saliva.
Measured: 30 days
Rate of oral mucositis
It will be measured through a clinical analysis, taking into account the World Health Organization (WHO) mucositis assessment scale.
Measured: 30 days
Periodontitis rate
Measured by clinical examination according to SEPA (Spanish Society of Periodontology) criteria for the classification of periodontal disease.
Measured: 30 days
Quality of life rate
It will be analyzed based on the quality of life questionnaire for head and neck cancer patients EORTC QLQ-H\&N35 Spanish version.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start3 Oct 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Valeria Pereira Riveros, University of Barcelona
- Investigators
- Tanya Pereira Riveros, Msc, Principal investigator, Universuty of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122636
- Sponsor's protocol ID
- 22/2021
- Acronym
- HNC
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With Head and Neck Cancer: Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06122636
- Acronym / sponsor ID
- HNC / 22/2021
- Conditions
- Quality of Life, Oral Mucositis, Dental Plaque, Periodontal Diseases, Xerostomia, Dysbiosis
- Keywords
- Radiotherapy, chemotherapy, surgery, probiotics, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratoryAn envelope with the same packaging, size, shape and color will be given, it will only differ from the placebo in that it will contain the active ingredient of the intervention which is Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus.Experimental group |
| Placebo group | Placebo comparator | Other: PlaceboThe placebo will be given in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age.
- Who give informed consent to participate in the study.
- With histologic diagnosis of head and neck cancer.
- Treated within the last year for head and neck cancer.
Key exclusion criteria (5 listed)
- Patients who do not wish to participate in the study.
- Patients with osteonecrosis.
- Inability to take oral medications.
- Allergic to probiotics.
- On active antibiotic treatment or having received antibiotic treatment in the last thirty days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratoryEach patient should take 1 sachet per day, dissolve it in a glass of water, hold in the mouth for 2-3 minutes and then swallow, for a period of 30 days. | Dietary supplement | Experimental group |
| PlaceboThe placebo will be administered in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention. | Other | Placebo group |
Primary outcome
Concentration of oral dysbiosis
Time frame: 30 days
Analyzed through microbiological qPCR study with 16 S sRNA primers, real-time quantitative PCR and comparative analysis with conventional culture looking for changes in the total count of the following periodontopathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Campylobacter rectus, Fusobacterium nucleatum and Candida culture.
Rate of xerostomia
Time frame: 30 days
It will be measured by sialometry, analyzing unstimulated salivary secretion and stimulated salivary secretion
Salivary ph concentration
Time frame: 30 days
It will be measured through paper strips, in one of the containers with accumulated saliva.
Rate of oral mucositis
Time frame: 30 days
It will be measured through a clinical analysis, taking into account the World Health Organization (WHO) mucositis assessment scale.
Periodontitis rate
Time frame: 30 days
Measured by clinical examination according to SEPA (Spanish Society of Periodontology) criteria for the classification of periodontal disease.
Quality of life rate
Time frame: 30 days
It will be analyzed based on the quality of life questionnaire for head and neck cancer patients EORTC QLQ-H\&N35 Spanish version.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Pereira Riveros, Msc principal investigator
Universuty of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory in people with Quality of Life and Oral Mucositis, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of oral dysbiosis (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.