Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy

NCT05855265 | Completed DMC

• 1 other identifier: 264200
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancers - Nasopharyngeal

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

study group (SG)

EXPERIMENTAL

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.

Device: photon therapy face mask

control group (CG)

EXPERIMENTAL

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.

Device: photon therapy face mask

Interventions

photon therapy face mask DEVICE

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,

control group (CG); study group (SG)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Khadra Mohamed Ali: lead
• Cairo University: collaborator

Study Sites (1)

faculty of physical therapy , Cairo university

Giza, Egypt

Location

Study Officials

• Ali

  assist professor - department of physical therapy for surgery - Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assisst professor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: July 30, 2020
• Primary Completion: April 30, 2022
• Study Completion: May 1, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

EG (1)