BridgeMD
Tests treatment safety and results for Oral Mucositis
Official title Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.
ClinicalTrials.gov ID: NCT05161091
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Agreeing not to take any treatment for mucositis other than the treatment proposed in this study, apart from the classic symptomatic treatment for...
- Able to give informed consent to participate in research.
You likely can't join if
- 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...
See the full eligibility criteria
- 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.
- 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...
- History of administration of the treatment (or equivalent) in the study.
- Anticipated difficulties in reading / understanding the protocol and its questionnaires.
- people in the exclusion period from another clinical trial
- Refusal of participation.
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.