Oral MucositisOROSOLNCT05161091
Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.
A study testing Topical application of Orosol® in people with Oral Mucositis, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Topical application of Orosol®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Nov 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patient, male or female, either
- treated with chemotherapy for hematological cancer (leukemia, lymphoma) and suffering from grade 2 to 4 mucositis (according to WHO / NCI-CTCAE), or
- treated with radiotherapy or radio-chemotherapy (cisplatin or cetuximab) for head and neck cancer and suffering from grade 2 to 4 mucositis (according to WHO / NCI-CTCAE),
- Agreeing not to take any treatment for mucositis other than the treatment proposed in this study, apart from the classic symptomatic treatment for mucositis recommended by WHO.
- Able to give informed consent to participate in research.
- Beneficiary of a Social Security scheme.
Who cannot join
- A woman who is pregnant, breastfeeding, or may be.
- Major subject under guardianship, curators, deprived of liberty, or under the safeguard of justice.
- Medical and / or surgical history deemed by the investigator to be incompatible with the study because it would invalidate any reliable assessment.
- General state of health considered pejorative (Karnofsky index <60).
- Type 1 or type 2 diabetic subject (presence of honey in Orosol®).
- Subject on an anticoagulant (AVK or AOD) (interaction of the cranberry contained in Orosol® with anticoagulants (in particular warfarin) with instability of the International Normalized Ratio; the AODs can potentially present the same type of interaction).
Show all 10Show fewer
- History of administration of the treatment (or equivalent) in the study.
- Anticipated difficulties in reading / understanding the protocol and its questionnaires.
- Subjects in the exclusion period from another clinical trial
- Refusal of participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Centre Jean-Perrin
Clermont-Ferrand
lise Laclautre
Michel Lapeyre
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Laurent Devoize
About this study
Official title: Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.
Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants.
It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and / or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing.
Read more
Depending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease.
Although, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.
Read the detailed description
Oral mucositis is one of the frequent and disabling effects of radiotherapy and chemotherapy, with an impact on the quality of life of patients and induced or prolonged hospital stays. It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing. Treatment is currently symptomatic, with little effectiveness. Orosol® is a medical device, osmotically active viscous solution. Applied to the surface of an ulcer, it forms a film and mechanically attracts the hypotonic fluid present under the injured surface, thus cleaning the ulcer of all contaminants present on the surface (dead cells, cell debris, bacterial toxins and chemical agents. toxic) and reducing pain and burning sensation. This mechanical action also cleanses the ulcer of toxic substances that inhibit cell growth and paves the way for healing. This device (class 1) is a medical device that complies with the requirements set by European regulations for the treatment of oral mucositis and has shown improvement in a preliminary study in patients with chemo-induced mucositis. However, its effectiveness has not yet been tested in the case of radiation-induced mucositis. The main objective of the research is to demonstrate the effectiveness of the curative treatment with Orosol® on the symptoms of chemo-induced or radiation-induced mucositis in patients treated for cancer by the evaluation at 28 days of the evolution of the mucositis via mucositis (WHO and NCI-CTCAE v3.0 scales) and food (WHO scales and functional signs of NCI-CTCAE v4.0) scores. The secondary objectives consist in evaluating during the treatment the mucositis score, the general state of health of the mouth, the burning sensation, the intensity of the pain on D1, D3, D5, D7, D14, D21 and D28 as well as analgesic consumption, the incidence of new ulcers, changes in anti-cancer treatment linked to mucositis and the tolerance of the treatment.
This is a prospective, randomized, double-blind, bicenter study to establish CE compliance in a new indication. 54 adult patients, treated by chemotherapy for haematological cancer or radiotherapy or radio-chemotherapy for head and neck cancer, with CTCAE grade ≥ 2 mucositis and agreeing not to take any treatment other than that studied (except the treatment symptomatic of mucositis recommended by the WHO), will be recruited during their treatment in the specialized services of the Clermont-Ferrand University Hospital or the Jean Perrin Center over a period estimated at 24 months. After information, collection of consent and verification of the selection criteria, patients will receive according to randomization (1: 1 stratified according to radio / chemotherapy) either the active treatment or a placebo. During the first visit, a clinical examination with evaluation of the grade of mucositis (WHO scale and clinical signs NCI-CTCAE v3.0), photographs of ulcers (retrospective control), evaluation of the state of the mouth (OAG (Oral Assessment Guide) grid), difficulty in feeding by the oral route (functional signs NCI- CTCAE v4.0) will be performed as well as assessments (VAS (Visual Analogic Scales) of pain and burning sensations before and 30 minutes after treatment. Visits are scheduled on D3, D5, D7, D14, D21 and D28 with clinical examination, photographs, evaluations of the condition of the mouth, difficulty in feeding, pain and burning sensation, collection of any adverse effects and changes in the anti-cancer treatment if necessary.
- Conditions
- Oral Mucositis
- Being tested
- Topical application of Orosol®, Topical application of Placebo comparator
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of Orosol®Device
Orosol® is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Orosol® every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.
Topical application of Placebo comparatorDevice
Placebo comparator is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Placebo comparator every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.
| Study group | Role | What they receive |
|---|---|---|
| Radio-induced oral mucositis / Medical Device | Experimental | Patient with radio-induced oral mucositis at least grade 2 treated with experimental medical device Receives: Device: Topical application of Orosol® |
| Radio-induced oral mucositis / Placebo comparator | Placebo comparator | Patient with radio-induced oral mucositis at least grade 2 treated with placebo Receives: Device: Topical application of Placebo comparator |
| Chemo-induced oral mucositis / Medical Device | Experimental | Patient with chemo-induced oral mucositis at least grade 2 treated with experimental medical device Receives: Device: Topical application of Orosol® |
| Chemo-induced oral mucositis / placebo comparator | Placebo comparator | Patient with chemo-induced oral mucositis at least grade 2 treated with placebo Receives: Device: Topical application of Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (WHO)
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the mucositis score according to the World Health Organization scale (from 0 (absence of mucositis) to 4 (Oral feeding not possible, enteral (tube) or parenteral feeding indicated))
Measured: At day 28
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (NCI-CTCAE v3.0)
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the mucositis score according to the National Cancer Institute Common Terminology Criteria for Adverse Events (clinical scale) (v 3.0) (from 0 (absence of mucositis) to 4 (Necrosis, spontaneous hemorrhage))
Measured: At day 28
Demonstrate the effectiveness of the curative treatment with Orosol® on oral feeding (NCI-CTCAE v4.0)
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the difficulty in feeding orally with the functional signs scale from the National Cancer Institute Common Terminology Criteria for Adverse Events (functional scale) (v 4.0) (from 0 (absence of mucositis) to 4 (Necrosis, Vital prognosis engaged))
Measured: At day 28
Secondary outcomes (9)
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item voice"
The OAG "item voice" scale is a scale from 1 (Normal) to 3 (highly impacted) assessing the difficulty of speaking
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item swallowing"
The OAG "item swallowing" scale is a scale from 1 (Normal) to 3 (highly impacted) assessing the difficulty of swallowing
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item tongue aspect"
The OAG "item tongue aspect" scale is a scale from 1 (pink, wet and presence of taste buds) to 3 (cracked, blistered) assessing the aspect of the tongue
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item salivation"
The OAG "item salivation" scale is a scale from 1 (normal) to 3 (absence of salivation) assessing the hyposialia
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item mucous membrane and gums"
The OAG "item mucous membrane and gums" scale is a scale from 1 (pink and wet) to 3 (ulcerations and / or bleeding) assessing the state of aggression of the mucous membranes
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "teeth"
The OAG "item teeth" scale is a scale from 1 (clean and free of debris) to 3 (widespread plaques and debris on all damaged gums and teeth) assessing the state of aggression of the teeth
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "lips"
The OAG "item lips" scale is a scale from 1 (smooth, dewy and damp) to 3 (ulcerations or bleeding) assessing the state of aggression of the lips
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Burning sensation
Assessment of burning symptom with visual analogical scale (from 0 (absence of burning sensation to 10 (strongest burning sensation imaginable)
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Pain intensity
Assessment of pain with visual analogical scale (from 0 (absence of pain sensation to 10 (strongest pain sensation imaginable)
Measured: At day 1, 3 , 5, 7, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start22 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Devoize, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161091
- Sponsor's protocol ID
- RBHP 2021 DEVOIZE (OROSOL)
- Other IDs
- 2021-A00488-33
- Acronym
- OROSOL
- Status last verified
- Aug 2024
- First submitted
- 22 Nov 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.
PubMed 21133051Velez I, Tamara LA, Mintz S. Management of oral mucositis induced by chemotherapy and radiotherapy: an update. Quintessence Int. 2004 Feb;35(2):129-36.
PubMed 15000636Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.
PubMed 16499139
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT05161091
- Acronym / sponsor ID
- OROSOL / RBHP 2021 DEVOIZE (OROSOL)
- Conditions
- Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2021 (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.
Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants.
It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and / or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing.
Depending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease.
Although, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.
Detailed description
Oral mucositis is one of the frequent and disabling effects of radiotherapy and chemotherapy, with an impact on the quality of life of patients and induced or prolonged hospital stays. It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing. Treatment is currently symptomatic, with little effectiveness. Orosol® is a medical device, osmotically active viscous solution. Applied to the surface of an ulcer, it forms a film and mechanically attracts the hypotonic fluid present under the injured surface, thus cleaning the ulcer of all contaminants present on the surface (dead cells, cell debris, bacterial toxins and chemical agents. toxic) and reducing pain and burning sensation. This mechanical action also cleanses the ulcer of toxic substances that inhibit cell growth and paves the way for healing. This device (class 1) is a medical device that complies with the requirements set by European regulations for the treatment of oral mucositis and has shown improvement in a preliminary study in patients with chemo-induced mucositis. However, its effectiveness has not yet been tested in the case of radiation-induced mucositis. The main objective of the research is to demonstrate the effectiveness of the curative treatment with Orosol® on the symptoms of chemo-induced or radiation-induced mucositis in patients treated for cancer by the evaluation at 28 days of the evolution of the mucositis via mucositis (WHO and NCI-CTCAE v3.0 scales) and food (WHO scales and functional signs of NCI-CTCAE v4.0) scores. The secondary objectives consist in evaluating during the treatment the mucositis score, the general state of health of the mouth, the burning sensation, the intensity of the pain on D1, D3, D5, D7, D14, D21 and D28 as well as analgesic consumption, the incidence of new ulcers, changes in anti-cancer treatment linked to mucositis and the tolerance of the treatment.
This is a prospective, randomized, double-blind, bicenter study to establish CE compliance in a new indication. 54 adult patients, treated by chemotherapy for haematological cancer or radiotherapy or radio-chemotherapy for head and neck cancer, with CTCAE grade ≥ 2 mucositis and agreeing not to take any treatment other than that studied (except the treatment symptomatic of mucositis recommended by the WHO), will be recruited during their treatment in the specialized services of the Clermont-Ferrand University Hospital or the Jean Perrin Center over a period estimated at 24 months. After information, collection of consent and verification of the selection criteria, patients will receive according to randomization (1: 1 stratified according to radio / chemotherapy) either the active treatment or a placebo. During the first visit, a clinical examination with evaluation of the grade of mucositis (WHO scale and clinical signs NCI-CTCAE v3.0), photographs of ulcers (retrospective control), evaluation of the state of the mouth (OAG (Oral Assessment Guide) grid), difficulty in feeding by the oral route (functional signs NCI- CTCAE v4.0) will be performed as well as assessments (VAS (Visual Analogic Scales) of pain and burning sensations before and 30 minutes after treatment. Visits are scheduled on D3, D5, D7, D14, D21 and D28 with clinical examination, photographs, evaluations of the condition of the mouth, difficulty in feeding, pain and burning sensation, collection of any adverse effects and changes in the anti-cancer treatment if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Radio-induced oral mucositis / Medical Device | Experimental | Device: Topical application of Orosol®Patient with radio-induced oral mucositis at least grade 2 treated with experimental medical device |
| Radio-induced oral mucositis / Placebo comparator | Placebo comparator | Device: Topical application of Placebo comparatorPatient with radio-induced oral mucositis at least grade 2 treated with placebo |
| Chemo-induced oral mucositis / Medical Device | Experimental | Device: Topical application of Orosol®Patient with chemo-induced oral mucositis at least grade 2 treated with experimental medical device |
| Chemo-induced oral mucositis / placebo comparator | Placebo comparator | Device: Topical application of Placebo comparatorPatient with chemo-induced oral mucositis at least grade 2 treated with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient, male or female, either
- Agreeing not to take any treatment for mucositis other than the treatment proposed in this study, apart from the classic symptomatic treatment for mucositis recommended by WHO.
- Able to give informed consent to participate in research.
- Beneficiary of a Social Security scheme.
Key exclusion criteria (10 listed)
- A woman who is pregnant, breastfeeding, or may be.
- Major subject under guardianship, curators, deprived of liberty, or under the safeguard of justice.
- Medical and / or surgical history deemed by the investigator to be incompatible with the study because it would invalidate any reliable assessment.
- General state of health considered pejorative (Karnofsky index <60).
- Type 1 or type 2 diabetic subject (presence of honey in Orosol®).
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 |
|---|---|---|
| Topical application of Orosol®Orosol® is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Orosol® every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product. | Device | Chemo-induced oral mucositis / Medical Device, Radio-induced oral mucositis / Medical Device |
| Topical application of Placebo comparatorPlacebo comparator is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Placebo comparator every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product. | Device | Chemo-induced oral mucositis / placebo comparator, Radio-induced oral mucositis / Placebo comparator |
Primary outcome
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (WHO)
Time frame: At day 28
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the mucositis score according to the World Health Organization scale (from 0 (absence of mucositis) to 4 (Oral feeding not possible, enteral (tube) or parenteral feeding indicated))
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (NCI-CTCAE v3.0)
Time frame: At day 28
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the mucositis score according to the National Cancer Institute Common Terminology Criteria for Adverse Events (clinical scale) (v 3.0) (from 0 (absence of mucositis) to 4 (Necrosis, spontaneous hemorrhage))
Demonstrate the effectiveness of the curative treatment with Orosol® on oral feeding (NCI-CTCAE v4.0)
Time frame: At day 28
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the difficulty in feeding orally with the functional signs scale from the National Cancer Institute Common Terminology Criteria for Adverse Events (functional scale) (v 4.0) (from 0 (absence of mucositis) to 4 (Necrosis, Vital prognosis engaged))
9 secondary outcomes
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item voice"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item swallowing"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item tongue aspect"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item salivation"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item mucous membrane and gums"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "teeth"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "lips"
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Burning sensation
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Pain intensity
Time frame: At day 1, 3 , 5, 7, 14, 21 and 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 21133051Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.
- Background: PubMed 15000636Velez I, Tamara LA, Mintz S. Management of oral mucositis induced by chemotherapy and radiotherapy: an update. Quintessence Int. 2004 Feb;35(2):129-36.
- Background: PubMed 16499139Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.
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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.
Laurent Devoize principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical application of Orosol® in people with Oral Mucositis, run by University Hospital, Clermont-Ferrand at 2 sites in France.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (WHO) (time frame: At day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161091, which also lists 3 linked publications.
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 12 Aug 2024.