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Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy (dermatitis)

Primary Purpose

Head and Neck Cancers - Nasopharyngeal

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
photon therapy face mask
Sponsored by
Khadra Mohamed Ali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancers - Nasopharyngeal

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients were free from any skin diseases, All patients enrolled to this study signed their informed consent,All the patients who had Nasopharyngeal tumor receiving radiotherapy who participated in this study, diagnosed by an oncologist and confirmed by MRI, C.T and laboratory investigations). Exclusion Criteria: patients with communication disorders, patients who were unwilling to take part in this treatment, patients with tumor recurrence, patients with tumor stage 3 or more and patients with skin diseases

Sites / Locations

  • faculty of physical therapy , Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group (SG)

control group (CG)

Arm Description

The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions and Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent .The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.

Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for control groups CG.The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.

Outcomes

Primary Outcome Measures

Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC)
The assessment of dermatitis by RTOG scale was conducted by the physician once per week during treatment period . The grading of the RTOG scale : Grade 0: no change, Grade 1: Slight atrophy; pigmentation change; some hair loss, Grade 2: Patch atrophy; moderate telangiectasia; total hair loss, Grade 3: Marked atrophy; gross telangiectasia and Grade 4: ulcer, bleeding, and necrosis
Dermoscopic score
Erythema was graded from 0 to 3 (Figure 1), where 0 5= no erythema, 1 = faint erythema, 2 = moderate erythema, and 3 = erosion. Scaling was graded from 0 to 2, where 0 = no scaling, 1=moderate scaling, and 2 = severe scaling. Similarly, pigmentation was graded from 0 to 2, where 0 = no pigmentation, 1= moderate pigmentation, and 2 = severe pigmentation. The score was then calculated by the addition of the aforementioned grades (erythema + scaling + pigmentation) to produce a score ranging from 0 to 7, where 7 is the most severe and 0 represents no erythema, no scaling, and no pigmentation. For assessment of therapeutic response, the dermoscopic score of a fixed area, calculated 2 weeks after the first radiation therapy session, four weeks after the first radiation therapy session and after finishing radiation therapy sessions, was compared with the baseline dermoscopic score of the same area.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
May 9, 2023
Sponsor
Khadra Mohamed Ali
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05855265
Brief Title
Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy
Acronym
dermatitis
Official Title
Response Of RTOG Scale and Dermoscopy to Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Khadra Mohamed Ali
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled trial (RCT), 60 HNC patients who underwent radiotherapy (RT) with or without chemotherapy represented the sample of the study. They were assigned randomly into two equal groups, control group (CG) and study group (SG). Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for both groups CG and SG. The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions. The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.
Detailed Description
This current study will be designed to prove the effect of photon therapy face mask on dermatitis post radiotherapy in patient with head and neck cancer. The measurements procedures will be conducted two times, before treatment application (pre-treatment) and after six weeks of treatment application (post-treatment). RTOG SCALE will be used to asset the patient before and after end of therapeutic procedures. Therapeutic intervention for the study was started at the same time for all groups of the study as following; Photon therapy will be applied from the first until the last day of RT (3×/week, 14 sessions). During the Photon therapy sessions, the whole irradiated area will be treated with 630 nm LED phototherapy. Treatment time will be 3 sessions per week for 30 min. set at 4 J/cm2 . Patients who will receive photon therapy during radiotherapy treatment within 2 weeks in addition to medical treatment and routine methods of nursing will be given during radiotherapy, including health education, skin self-care, and skin protective agent. 0.9% normal saline cotton balls will be used to gently clean the wound and remove necrotic tissue, and the wound will be dried with sterile gauze.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancers - Nasopharyngeal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group (SG)
Arm Type
Experimental
Arm Description
The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions and Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent .The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.
Arm Title
control group (CG)
Arm Type
Experimental
Arm Description
Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for control groups CG.The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.
Intervention Type
Device
Intervention Name(s)
photon therapy face mask
Intervention Description
In this study the patients were randomly assigned into two equal groups after agreeing to participate through signing an informed consent.,Out of 70 identified Nasopharyngeal tumor receiving radiotherapy, only 60 subjects completed the full requirements of the study,Participant's age ranged from 30-60 yearsThe subjects in control group (CG) were treated with their medical treatment in addition to routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent. 0.9% normal saline cotton balls will be used to gently clean the wound and remove necrotic tissue, and the wound was dried with sterile gauze. The subjects in study group (SG) were received photon therapy during radiotherapy treatment. In addition to medical treatment and routine methods of nursing,
Primary Outcome Measure Information:
Title
Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC)
Description
The assessment of dermatitis by RTOG scale was conducted by the physician once per week during treatment period . The grading of the RTOG scale : Grade 0: no change, Grade 1: Slight atrophy; pigmentation change; some hair loss, Grade 2: Patch atrophy; moderate telangiectasia; total hair loss, Grade 3: Marked atrophy; gross telangiectasia and Grade 4: ulcer, bleeding, and necrosis
Time Frame
once per week during treatment period for 6 weeks
Title
Dermoscopic score
Description
Erythema was graded from 0 to 3 (Figure 1), where 0 5= no erythema, 1 = faint erythema, 2 = moderate erythema, and 3 = erosion. Scaling was graded from 0 to 2, where 0 = no scaling, 1=moderate scaling, and 2 = severe scaling. Similarly, pigmentation was graded from 0 to 2, where 0 = no pigmentation, 1= moderate pigmentation, and 2 = severe pigmentation. The score was then calculated by the addition of the aforementioned grades (erythema + scaling + pigmentation) to produce a score ranging from 0 to 7, where 7 is the most severe and 0 represents no erythema, no scaling, and no pigmentation. For assessment of therapeutic response, the dermoscopic score of a fixed area, calculated 2 weeks after the first radiation therapy session, four weeks after the first radiation therapy session and after finishing radiation therapy sessions, was compared with the baseline dermoscopic score of the same area.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients were free from any skin diseases, All patients enrolled to this study signed their informed consent,All the patients who had Nasopharyngeal tumor receiving radiotherapy who participated in this study, diagnosed by an oncologist and confirmed by MRI, C.T and laboratory investigations). Exclusion Criteria: patients with communication disorders, patients who were unwilling to take part in this treatment, patients with tumor recurrence, patients with tumor stage 3 or more and patients with skin diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali
Organizational Affiliation
assist professor - department of physical therapy for surgery - Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy , Cairo university
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The purpose of this study was to evaluate the effect of photon therapy in reducing the dermatitis during and post radiotherapy in patients with head and neck tumors. A randomized controlled trial (RCT), 60 HNC patients who underwent radiotherapy (RT) with or without chemotherapy represented the sample of the study. They were assigned randomly into two equal groups, control group (CG) and study group (SG). Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for both groups CG and SG. The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions. The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded.
IPD Sharing Time Frame
Photon therapy was applied from the beginning of the treatment till the end of the treatment with radiation therapy (three times per week, for six weeks with a total of 18 sessions). During the photon therapy sessions, the irradiated area was treated. Treatment wavelength parameter was 630 nm LED phototherapy 15. Treatment time per session was 20 min . data available at May 2022.
IPD Sharing Access Criteria
inclusion Criteria: The subject selection was according to the following criteria: Age ranged between 30-60 years. Male and female patients participated in the study. All the patients had nasopharyngeal type of head and neck cancers were receiving radiation therapy (IMRT). All patients were free from any skin diseases. All patients enrolled to this study signed their informed consent. Exclusion Criteria: The potential participants were excluded if they met one of the following criteria: Patients with communication disorders. Patients who were unwilling to take part in this treatment. Patients with skin diseases. patients with tumor recurrence. patients with tumor stage 3 or more.

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Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy

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