Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.

NCT05161091 | Recruiting

• 2 other identifiers: RBHP 2021 DEVOIZE (OROSOL)2021-A00488-33
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (3)

• 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))

  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))

  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))

  At day 28

Secondary Outcomes (9)

• Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item voice"

  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"

  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"

  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"

  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"

  At day 1, 3 , 5, 7, 14, 21 and 28

Study Arms (4)

Radio-induced oral mucositis / Medical Device

EXPERIMENTAL

Patient with radio-induced oral mucositis at least grade 2 treated with experimental medical device

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

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

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

Device: Topical application of Placebo comparator

Interventions

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.

Chemo-induced oral mucositis / Medical Device; Radio-induced oral mucositis / Medical Device

Topical application of Placebo comparator DEVICE

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.

Chemo-induced oral mucositis / placebo comparator; Radio-induced oral mucositis / Placebo comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 (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.

You may not qualify 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 instability of the International Normalized Ratio; the AODs can potentially present the same type of interaction).
• History of administration of the treatment (or equivalent) in the study.
• Anticipated difficulties in reading / understanding the protocol and its questionnaires.
• Refusal of participation.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

Centre Jean-Perrin

Clermont-Ferrand, France

NOT YET RECRUITING

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 21133051 BACKGROUND

• Velez I, Tamara LA, Mintz S. Management of oral mucositis induced by chemotherapy and radiotherapy: an update. Quintessence Int. 2004 Feb;35(2):129-36.

  PMID: 15000636 BACKGROUND

• Peterson DE. New strategies for management of oral mucositis in cancer patients. J Support Oncol. 2006 Feb;4(2 Suppl 1):9-13.

  PMID: 16499139 BACKGROUND

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Laurent Devoize

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 16, 2021
• Study Start: November 22, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

FR (2)