Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis
Primary Purpose
Oral Mucositis (Ulcerative)
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bioptron Light Therapy (BLT)
Sponsored by
About this trial
This is an interventional treatment trial for Oral Mucositis (Ulcerative)
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
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bioptron Light Therapy (BLT) group
Routine medical care group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Oral Ulceration
WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04493879
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis (Ulcerative)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioptron Light Therapy (BLT) group
Arm Type
Experimental
Arm Description
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
Arm Title
Routine medical care group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Bioptron Light Therapy (BLT)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Oral Ulceration
Description
WHO oral mucositis scale (OMS) and the Common toxicity criteria scale (CTCS)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Eid
Organizational Affiliation
Ass.Prof
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Bioptron Light Therapy (BLT) on Post Chemotherapy Oral Mucositis
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