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

NCT ID: NCT04493879

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2019-08-20

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

Conditions

Oral Mucositis (Ulcerative)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bioptron Light Therapy (BLT) group

Received Bioptron Light Therapy (BLT) ten minutes every day for one month plus the routine medical treatment of oral mucositis(Analgesics, anti-inflammatory medication and antimicrobial therapy for any new mouth infections

Group Type: EXPERIMENTAL

Bioptron Light Therapy (BLT)

Intervention Type: OTHER

BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)

Routine medical care group

Received only the routine medical care of oral mucositis for one month this consists of analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections

Group Type: EXPERIMENTAL

Bioptron Light Therapy (BLT)

Intervention Type: OTHER

BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)

Interventions

Bioptron Light Therapy (BLT)

BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Eid

assistant professor of physical therapy for surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Eid

Role: PRINCIPAL_INVESTIGATOR

Ass.Prof

Locations

Marwa Eid

Cairo, , Egypt

Countries

Egypt

Other Identifiers

68

Identifier Type: -

Identifier Source: org_study_id