Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis
Primary Purpose
Mucositis Oral
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Benzydamine Hydrochloride
Solcoseryl and pumpkin seed oil
Sponsored by
About this trial
This is an interventional treatment trial for Mucositis Oral focused on measuring Oral Mucositis, Pumpkin seed oil, Solcoseryl
Eligibility Criteria
A- Inclusion criteria:
- Patients having clinical signs of chemotherapy-induced or radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III and IV)
- Patients over the age of 18 years
- Patients having no history of allergy, allergic rhinitis and asthma
B- Exclusion criteria:
- Patients allergic to the used treatment
- Patient receiving systemic steroids
- Patients who don't approve to participating in the clinical trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Benzydamine Hydrochloride
90%solcoseryl and 10% pumpkin seed oil
Arm Description
Control Group:Benzydamine Hydrochloride spray by mouth three times daily for 20 days. Follow up: The patients will be recalled at one week interval for 20 days.
Intervention group: 90% solcoseryl and 10% pumpkin seed oil spray by mouth three times daily for 20 days
Outcomes
Primary Outcome Measures
Clinical improvement
World Health Organization (WHO)scale.It is graded from 0 to 4. If the patient has no signs and symptoms, it is graded as 0. If the patient has painless ulcers, edema, or mild soreness, it is graded as 1. If there is painful erythema, edema, or ulcers but able to eat, it is graded as 2. If there is painful erythema, edema, or ulcers but unable eat, it is graded as 3. If there a requirement for parenteral or enteral support, it is graded as 4
Secondary Outcome Measures
Quality of life
Patient-Reported Oral Mucositis( PROMS scale) will measure Quality of life .The PROMS scale consists of 10, 100-mm horizontal visual analogue scales addressing oral functions affected by oral mucositis. Participants will be asked to mark a point on the line that best represents their present intra-oral condition.During the baseline examination and prior to their completion of the actual PROMS scale questionnaire, participants were subjected to a few training test-visual analogue scale questions focused on simple everyday topics to familiarize them with the concept of visual analogue scale assisted measurements. The participants will complete the PROMS questionnaire thrice; baseline, after the first week, and at the end of the study after the second week.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04303312
Brief Title
Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis
Official Title
Clinical Evaluation of Solcosreyl and Pumpkin Seed Oil Versus Benzydamine Hydrochloride in Management of Patients With Chemotherapy and Radiotherapy Induced Oral Mucositis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ghada zaki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Oral mucositis consequences can range from pain, decreased oral intake, impaired speech and swallowing to adverse events as severe as septicemia, increased hospitalization, and G-tube feeding A wide variety of agents have been tested to prevent OM or reduce its severity.This trial will assess the usefulness of solcoseryl and pumpkin seed oil versus Benzydamine Hydrochloride mouth wash in management of oral mucositis in patients receiving radiotherapy and/or chemotherapy.
Detailed Description
The term "mucositis" was introduced to describe inflammation of the oral mucosa induced by radiotherapy, chemotherapy and bone marrow transplantation. At present, oral mucositis is considered to be the most serious non-hematological complication of cancer treatment.
Numerous predisposing factors have been blamed for oral mucositis, including: the type of tumor involved, age of the patient, dental health, the nutritional condition of the patient, the maintenance of kidney and liver function and the type of cytostatic agent used.
Clinically, oral Mucositis may appear as erythema, edema or ulceration that can be accompanied by alterations ranging from mild burning sensation to large and painful ulcers that wor¬sen patient's quality of life and limit basic oral functions such as speech, swallowing of saliva or eating.
According to Multinational Association for Supportive Care in cancer and the International Society of Oral Oncology (MASCC/ISOO) guidelines for the management of mucositis, Management of oral mucositis is divided into the following sections: nutritional support, pain control, oral decontamination, palliation of dry mouth, management of oral bleeding and therapeutic interventions for oral mucositis.
Since the primary symptom of oral mucositis is pain which significantly affects nutritional intake, mouth care and quality of life, thus, management of mucositis pain is a primary component of any mucositis management strategy. Use of saline mouth rinses, ice chips and topical mouthrinses containing an anesthetic such as 2% viscous lidocaine can help in reducing pain
Based on the pathogenesis of mucositis with complex biological inflammatory pathways, various therapeutic approach have been proposed to improve oral mucositis.
The current guidelines recommend the use of non-medicated oral rinses such as Benzydamine hydrochloride mouthwash and the use of short term pain killers. Benzydamine hydrochloride - which is a non-steroidal anti-inflammatory drug - can be used in the form of mouth rinse to reduce the severity of oral mucositis. Other management strategies include cryotherapy before the start of chemotheraputic agent administration and application of low-level laser therapy. Palifermin (Keratinocyte growth factor) is the only recommended preventive measure recommended by the ESMO Clinical Practice Guidelines.
Solcoseryl, is a protein free standardized dialysate of calf blood extracted by ultrafiltration. The main constituents of Solcoseryl are inorganic electrolytes (chloride, phosphate, sodium, potassium, calcium, and magnesium) and low-molecular weight substances, including amino acids, biogenic amines and polyamines, sphingolipids, hexoses, eicosanoids, lactate, acetate, succinate, choline, vitamins, adenosine monophosphate (AMP) and inositol phospho-oligosaccharides.
Solcoseryl has a number of beneficial effects. The most important of them include enhanced cellular glucose uptake, improvement of oxygen utilization and energy metabolism , neuroprotective effects, reduction of oxidative stress and apoptosis, accelerated wound healing and improvement of blood microcirculation.
Pumpkin seed oils are good source of vitamins, minerals and anti-oxidants. Active components include fatty acid, 19.4% saturated fatty acids (palmitic acid and stearic acid), 80.7% unsaturated fatty acids (linoleic acid and oleic acid) , Tocopherol (β-tocopherol, γ-tocopherol, δ-tocopherol), carotenoids including β-carotene and lutein, Phytosterols or plant sterols, Amino acid Glutamic and aspartic acid, leucine, valine, phenylalanine, and tryptophan are among the amino acids identified. It has many therapeutic activities like antioxidant activity, anti inflammatory, antimicrobial activity, and anti carcinogenic effect. It is thus a good candidate to counteract the ongoing development of oral mucositis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
Keywords
Oral Mucositis, Pumpkin seed oil, Solcoseryl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare Provider
Masking Description
Treatment will be placed in identical spray containers
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Benzydamine Hydrochloride
Arm Type
Active Comparator
Arm Description
Control Group:Benzydamine Hydrochloride spray by mouth three times daily for 20 days.
Follow up: The patients will be recalled at one week interval for 20 days.
Arm Title
90%solcoseryl and 10% pumpkin seed oil
Arm Type
Experimental
Arm Description
Intervention group: 90% solcoseryl and 10% pumpkin seed oil spray by mouth three times daily for 20 days
Intervention Type
Other
Intervention Name(s)
Benzydamine Hydrochloride
Intervention Description
Patients will rinse by mouth three times daily for 20 days
Intervention Type
Combination Product
Intervention Name(s)
Solcoseryl and pumpkin seed oil
Intervention Description
Patients will receive by mouth three times daily for 20 days
Primary Outcome Measure Information:
Title
Clinical improvement
Description
World Health Organization (WHO)scale.It is graded from 0 to 4. If the patient has no signs and symptoms, it is graded as 0. If the patient has painless ulcers, edema, or mild soreness, it is graded as 1. If there is painful erythema, edema, or ulcers but able to eat, it is graded as 2. If there is painful erythema, edema, or ulcers but unable eat, it is graded as 3. If there a requirement for parenteral or enteral support, it is graded as 4
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Quality of life
Description
Patient-Reported Oral Mucositis( PROMS scale) will measure Quality of life .The PROMS scale consists of 10, 100-mm horizontal visual analogue scales addressing oral functions affected by oral mucositis. Participants will be asked to mark a point on the line that best represents their present intra-oral condition.During the baseline examination and prior to their completion of the actual PROMS scale questionnaire, participants were subjected to a few training test-visual analogue scale questions focused on simple everyday topics to familiarize them with the concept of visual analogue scale assisted measurements. The participants will complete the PROMS questionnaire thrice; baseline, after the first week, and at the end of the study after the second week.
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
A- Inclusion criteria:
Patients having clinical signs of chemotherapy-induced or radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III and IV)
Patients over the age of 18 years
Patients having no history of allergy, allergic rhinitis and asthma
B- Exclusion criteria:
Patients allergic to the used treatment
Patient receiving systemic steroids
Patients who don't approve to participating in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada Zaki, Msc
Phone
01111122658
Email
ghada.zaki@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis
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