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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
Ghada zaki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis Oral focused on measuring Oral Mucositis, Pumpkin seed oil, Solcoseryl

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

A- Inclusion criteria:

  1. Patients having clinical signs of chemotherapy-induced or radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III and IV)
  2. Patients over the age of 18 years
  3. Patients having no history of allergy, allergic rhinitis and asthma

B- Exclusion criteria:

  1. Patients allergic to the used treatment
  2. Patient receiving systemic steroids
  3. 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

    First Posted
    March 4, 2020
    Last Updated
    August 2, 2021
    Sponsor
    Ghada zaki
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    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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