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Mucositis OralPhase 3NCT04303312

Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis

A Phase 3 study testing Benzydamine Hydrochloride and Solcoseryl and pumpkin seed oil in people with Mucositis Oral, run by Ghada zaki.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Mucositis Oral
What is being tested?
Benzydamine Hydrochloride and Solcoseryl and pumpkin seed oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
Dec 2021to Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Clinical Evaluation of Solcosreyl and Pumpkin Seed Oil Versus Benzydamine Hydrochloride in Management of Patients With Chemotherapy and Radiotherapy Induced Oral Mucositis

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.

Read the 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.

Conditions
Mucositis Oral
Being tested
Benzydamine Hydrochloride, Solcoseryl and pumpkin seed oil
Keywords
Oral Mucositis, Pumpkin seed oil, Solcoseryl
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Benzydamine HydrochlorideOther

    Patients will rinse by mouth three times daily for 20 days

  • Solcoseryl and pumpkin seed oilCombination product

    Patients will receive by mouth three times daily for 20 days

Study groups in NCT04303312
Study groupRoleWhat they receive
Benzydamine HydrochlorideActive comparatorControl 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.
Receives: Combination Product: Solcoseryl and pumpkin seed oil
90%solcoseryl and 10% pumpkin seed oilExperimentalIntervention group: 90% solcoseryl and 10% pumpkin seed oil spray by mouth three times daily for 20 days
Receives: Other: Benzydamine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 20 days

Secondary outcomes (1)
  1. 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.

    Measured: 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study startDec 2021 (estimated)
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completionMar 2022 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303312
Sponsor's protocol ID
OMED 2_2_1
Status last verified
Aug 2021
First submitted
4 Mar 2020
Last updated
6 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benzydamine Hydrochloride and Solcoseryl and pumpkin seed oil in people with Mucositis Oral, run by Ghada zaki.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ghada Zaki, Msc (01111122658, ghada.zaki@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement (time frame: 20 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Aug 2021.

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