Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy
dermatitis
Response Of RTOG Scale and Dermoscopy to Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy
dermatitis
Response Of RTOG Scale and Dermoscopy to Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy
Sponsor study identifier
interventional
60
1 country
1
Study Start
July 30, 2020
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2020
Actual (reported)April 30, 2022
Actual (reported)May 1, 2022
Actual (reported)May 2, 2023
Actual (reported)May 11, 2023
Actual (reported)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
once per week during treatment period for 6 weeks
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.
3 months
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.
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,
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
faculty of physical therapy , Cairo university
Giza, Egypt
Ali
assist professor - department of physical therapy for surgery - Cairo university
60 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2023
First Posted
May 11, 2023
Study Start
July 30, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 30, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)Last Updated
May 11, 2023
Record last verified: 2023-05
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.
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