Oral MucositisNCT05994638
Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
A study testing Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3) in people with Oral Mucositis, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial summary
The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 21 Aug 2023to 30 Nov 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men, 18-75 years old
- Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis
- Patients with dryness in mouth
- Signed informed consent.
Who cannot join
- Intake of supplements containing plant extracts, polyphenols or anthocyanins
- Participation in another clinical trial,
- Women who are pregnant, planning to become pregnant during the study or breastfeeding,
- Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation.
- Hypersensitivity/allergy to any of the ingredient
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Uniwersyteckie Centrum Stomatologiczne GUMed
Gdansk, 80-204
Barbara Khaidakov, PhD, 798 210 651 ext. +48, barbara.khaidakov@aronpharma.pl
Iwona Ordyniec-Kwaśnica, MD
About this study
The aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.
Read the detailed description
The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.
- Conditions
- Oral Mucositis
- Being tested
- Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
- Keywords
- Radiotherapy, Head and neck cancer, Dysphagia, Oral Mucositis
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)Dietary supplement
Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3
| Study group | Role | What they receive |
|---|---|---|
| Aerosol for use in the oral cavity | Experimental | Group of 10 patients with head and neck cancer who have undergone radiotherapy Receives: Dietary Supplement: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects after radiotherapy
Based on a questionnaire
Measured: Baseline, 1 month
Secondary outcomes (1)
Impact of dysphagia on quality of life
Based on a MDADI questionnaire
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start21 Aug 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994638
- Sponsor's protocol ID
- 08-AP-ONCOS
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy
- ClinicalTrials.gov ID
- NCT05994638
- Acronym / sponsor ID
- 08-AP-ONCOS
- Conditions
- Oral Mucositis
- Keywords
- Radiotherapy, Head and neck cancer, Dysphagia, Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 16 Aug 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 aim of the study is to demonstrate in a clinical condition the effectiveness of a preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting cancer patients in minimizing side effects after a radiation therapy cycle.
Detailed description
The study will be conducted on a group of 10 patients with head and neck cancer who have undergone radiation therapy and experience side effects such as discomfort/changes in the oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before and after the study, an assessment questionnaire related to the side effects of radiation therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerosol for use in the oral cavity | Experimental | Dietary Supplement: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)Group of 10 patients with head and neck cancer who have undergone radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women and men, 18-75 years old
- Patients with head and neck cancer or other types of cancer after radiotherapy who suffer from oral mucositis
- Patients with dryness in mouth
- Signed informed consent.
Key exclusion criteria (5 listed)
- Intake of supplements containing plant extracts, polyphenols or anthocyanins
- Participation in another clinical trial,
- Women who are pregnant, planning to become pregnant during the study or breastfeeding,
- Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation.
- Hypersensitivity/allergy to any of the ingredient
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 |
|---|---|---|
| Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3 | Dietary supplement | Aerosol for use in the oral cavity |
Primary outcome
Side effects after radiotherapy
Time frame: Baseline, 1 month
Based on a questionnaire
1 secondary outcome
Impact of dysphagia on quality of life
Time frame: Baseline, 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Uniwersyteckie Centrum Stomatologiczne GUMed
Gdansk, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3) in people with Oral Mucositis, run by AronPharma Sp. z o. o. at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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 Poland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects after radiotherapy (time frame: Baseline, 1 month). 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 13 Oct 2023.