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Completed

NCT Number: NCT05855265

Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy

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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Key information

Conditions

Head and Neck Cancers - Nasopharyngeal

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy , Cairo university

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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,

Primary outcomes

  1. Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC)

    Time frame: once per week during treatment period for 6 weeks

    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

  2. Dermoscopic score

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Khadra Mohamed Ali

Other

Collaborators

  • Cairo University

Registry information

Official study title

Response Of RTOG Scale and Dermoscopy to Photon Therapy Face Mask on Dermatitis Post Head and Neck Radiotherapy

Acronym: dermatitis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 11, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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