NCT04493879

Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis

Completed NA Last updated 30 July 2020

What this trial tests

NA trial testing Bioptron Light Therapy (BLT) in Oral Mucositis (Ulcerative) in 30 participants. Completed in 20 August 2019.

Timeline

10 June 2019

Primary endpoint
20 July 2019

20 August 2019

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	10 June 2019
Primary completion	20 July 2019
Estimated completion	20 August 2019
Sites	1 location across Egypt

Drugs / interventions tested

• Bioptron Light Therapy (BLT)

Conditions studied

• Oral Mucositis (Ulcerative) — all drugs for Oral Mucositis (Ulcerative) →

Sponsor

Cairo University

Who can join

Adults 35 to 55, any sex, with Oral Mucositis (Ulcerative). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.