Clinical trial NCT04493879: Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis
Official title: Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis (Ulcerative)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to study the effect of Bioptron light therapy (BLT) on oral mucositis after receiving chemotherapy in patients with head and neck cancer,Oral mucositis (OM) is a common and severe acute side-effect of many oncologic treatments, especially in patients treated for head and neck cancer. It affects quality of life and require supportive care and proper treatment plane.

This study had been conducted on thirty cancer patients (head \&neck) receiving chemotherapy \& radiotherapy (males and females) with oral mucositis with ulceration and pain(grade 2 and more), their age ranged from 35 to 55 years, capable of understanding the study assessment method and willing to complete the current study, they were free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes mellitus. Patients were randomly allocated from patients from the National Cancer Institute, Cairo University. Group A (BLT group): This group consisted of 15 patients receiving BLT for about 10 minutes every day for thirty days in addition to routine oral mucositis medical care (Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections), Group B (Control group): This group consisted of 15 patients receiving daily routine oral mucositis medical care(Analgesics, anti-inflammatory treatment and antimicrobial treatment for any new mouth infections) for thirty days The methods of evaluation in the current study were the WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS). At the same time, the treatment equipment was the polarized light therapy device Bioptron Compact III (PAG-860 manufactured in Switzerland) Assessment by WHO oral mucositis scale and (OMS) and (CTCS) were used before treatment and after treatment to measure improvement in oral mucositis.

The results of WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS) were assessed first at the beginning of the study and one month after the end of the study; calculation of mean, standard deviation, minimum and maximum for each group was done by descriptive statistics, means comparison between the two groups pre and post-application and within each group was made using The t-test. With a level of significance Alpha point of 0.05


Eligibility criteria: Inclusion Criteria:

* Cancer patients (head \&neck) receiving chemotherapy \& radiotherapy
* Males and females
* Age ranged from 35-55 years
* All patients capable of understanding the study assessment method and willing to complete the current study
* Patients free from any immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .

Exclusion Criteria:

* Patients suffering from immunodeficiency disorders or diseases that could impair the healing process and impact the results as diabetes .
* Cognitive impairment

Primary outcomes:
measure: Oral Ulceration
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
affiliation: Ass.Prof
name: Marwa Eid
role: PRINCIPAL_INVESTIGATOR
References: