Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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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

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Oral Mucositis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Aerosol for use in the oral cavity

Group of 10 patients with head and neck cancer who have undergone radiotherapy

Group Type EXPERIMENTAL

Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)

Intervention Type DIETARY_SUPPLEMENT

Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3

Interventions

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Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)

Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No