Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Wounds and Injuries

Rare Diseases

Head and Neck Neoplasms

Radiodermatitis

Dermatitis

Skin Diseases

Radiation Injuries

Acute Graft Versus Host Disease

03 patients with grade 2 to 4 radiodermatitis after radiotherapy for the treatment of head and neck cancer submitted to a PBM/PDT therapy protocol

Focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 633 to 830 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy

Photobiomodulation Therapy

Rebeca B Cecatto, M.D. Ph.D.

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Head and Neck Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis treated with PBM and/or PDT. This is a case series report and the study data will be extracted from the medical records of four head and neck cancer patients with grade 2 to 4 followed up from 2021 at the Laser Therapy Outpatient Clinic in a Universitarian Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS) and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM/PDT therapy. Data with positive or negative results will be reported.

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Head and Neck Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis Grade 2 to 4, treated with PBM/PDT. This is a case series report and the study data will be extracted from the medical records of four head and neck cancer patients with grade 2 to 4 RD followed up from 2021 at the Laser Therapy Outpatient Clinic in a Universitarian Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS) and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM/PDT therapy. The assessment will be done pre-treatment, weekly during PBM therapy and post-treatment. The PBM therapy are focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 630 to 830 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy Data with positive or negative results will be reported.

The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients

The Use of Photobiomodulation in the Management of Radiotherapy Side Effects: Case Series of Head and Neck Cancer Patients

Evaluation of lesion measurement in centimeters

RTOG scale assess the degree and intensity of RD. It identifies degree 0 (no reaction), 1 (faint erythema, dry desquamation, epilation, diminished sweating), 2 (moderate, brisk erythema, exudative dermatitis in plaques and moderate edema), 3 (exudative dermatitis, besides cutaneous folds and intense edema) and 4 (ulceration, hemorrhage, necrosis).

VAS Scale assess the pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

University of Nove de Julho

Professor Rebeca Boltes Cecatto

Breast Neoplasms

Anti-Inflammatory Agents

Respiratory System Agents

All Drugs and Chemicals

Herbal and Botanical

Betamethasone

Betamethasone Valerate

Betamethasone-17,21-dipropionate

Betamethasone benzoate

Betamethasone sodium phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Anti-Asthmatic Agents

Olive

Patients will apply Betamethasone Valerate 0.1% cream to the irradiated area twice a day.

Patients will apply prepared Olive Oil cream to the irradiated area twice a day.

Patients will apply prepared base cream to the irradiated area twice a day.

Olive oil prepared in a base cream to be applied to irradiated areas.

Olive oil cream

Betamethasone valerate prepared in a base cream to be applied to irradiated areas.

Betamethasone Valerate Cream

The base cream used for preparation of both the betamethasone valerate cream and olive cream will be used as a placebo control to be applied to irradiated areas.

Base Cream

Israa Kamal, BSc

Samar Farid, PhD

Mohamed Kelaney, MD, PhD

This study aims to compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis (ARD) in breast cancer patients treated with radiation. Betamethasone valerate, olive oil cream and the base cream will be compared in a randomized trial to evaluate and compare the development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score, percentage of patients with the maximum observed ARD grade for each arm of the study, percentage of patients with moist desquamation for each arm of the study, percentage of radiodermatitis-free patients at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy). In addition, the patients' quality of life will be evaluated using Dermatology Life Quality Index (DLQI).

Aim of the study:

* This study will be conducted to compare the efficacy of topical steroid cream and topical olive oil cream instituted from the start of radiotherapy in the prevention of acute radiation dermatitis in breast cancer patients.

Objectives:

1. To compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis in breast cancer patients.
2. To provide prospective data evaluating the quality of life (QoL), as most data on QoL in breast cancer patients are derived from cross-sectional studies.

   Methodology:

   Study Design:

   • This is a prospective, double blinded, randomized, parallel study.

   Study subjects:

   A total of 132 (120 + 12) participants will be recruited in order to achieve a statistical power of 0.8, using an alpha of 0.05.Sample size calculation was performed a priori using G-Power v 3.1. based on multiple comparisons of proportions using Chi-square (χ2) test. The maximal intensity of dermatitis during treatment will be measured in each group in the three groups. The calculations will be based on the effect size of 0.284, defined by Cramer's V as medium effect .

   • The recruited patients will be randomly distributed into three groups: Group 1: Patients will apply betamethasone valerate 0.1% cream to the irradiated area twice a day.

   Group 2: Patients will apply prepared olive oil cream to the irradiated area twice a day.

   Group 3 : Patients will apply prepared base cream to the irradiated area twice a day.
   * The three different creams will have the same base .
   * All applications of the creams will be started at the initiation of radiation therapy. Creams will be applied seven days a week during the radiation therapy period, and continued for two weeks after the completion of radiation therapy. The application of the cream will be after the radiation session and 12 hours later, and in the radiation free days the patient will apply every 12 hours.
   * If the patient develops ARD she will continue our prophylactic creams while taking her medical treatment according to the grade of ARD.
   * Those patients that meet the inclusion criteria will be invited to participate before beginning their radiotherapy process (T0) and data will be collected. Data related to treatment will be obtained from the patients' medical records.

   The data to be collected:
   * Age,
   * marital status,
   * schooling,
   * smoker or non-smoker,
   * Fitzpatrick skin type, which reflects skin complexion and sensitivity to sun Type l; always sunburn/never sun tan, Type 2; always sunburn/little sun tan, Type 3; sometimes sunburn/always sun tan, Type 4; never sunburn/always sun tan ,
   * breast size (full bust circumference),
   * body mass index (BMI),
   * comorbidities,
   * the pathological stage,
   * left or right breast cancer,
   * surgery,
   * previous chemotherapy and type of regimen,
   * Radiotherapy-related variables (Radiotherapy field distribution, number of fields of radiation, total prescribed dose, daily dose, energy of radiation).

     * Patients will be evaluated weekly during the radiation therapy (3-6 weeks) and 2 weeks after the radiation therapy at the following times :

   T1 = 7 days after beginning treatment +/- 3 days; T2 = 14 days after beginning treatment +/- 3 days; T3 = 21 days after beginning treatment +/- 3 days; T4 = 28 days after beginning treatment+/- 3 days; T5 = 35 days after beginning treatment+/- 3 days; T6 = 42 days after beginning treatment+/- 3 days; T7 = 49 days after beginning treatment+/- 3 days. T8 = 56 days after beginning treatment+/- 3 days.

   • The Radiation Therapy Oncology Group (RTOG) scale will be used to classify skin toxicity , Grade 0: being no change; Grade 1: follicular, faint, or dull erythema/epilation/dry desquamation/ decreased sweating; Grade 2: tender or bright erythema, patchy moist desquamation/moderate edema; Grade 3: confluent, moist desquamation other than skin folds, pitting edema; Grade 4: ulceration, hemorrhage, necrosis.

   • To evaluate the impact caused by radiodermatitis, we will use a validated Arabic questionnaire Dermatology Life Quality Index (DLQI).

   Patient Consent:

   • An informed written consent will be taken from all patients. The form will be explained to each patient or her caregiver before asking them to sign it.

   Outcomes to be evaluated:
   * Development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score {T1=7 days after beginning treatment +/- 3 days; to T8=56 days after beginning treatment+/- 3 days}.

     -Percentage of patients with the maximum observed ARD grade for each arm of the study ,

     -Percentage of patients with moist desquamation for each arm of the study \[20\],

     -Frequencies of different ARD grades at each time point \[18\],

     -Percentage of patients radiodermatitis free at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy),

     - Mean ARD grade at the different observation time points for each group .

     -Time of development of acute radiodermatitis .
   * Patients quality of life will be measured using an Arabic version of validated questionnaire {T1=7 days after beginning treatment +/- 3 days to T8=56 days after beginning treatment+/- 3 days} .
   * Patients 'subjective symptoms (itching, pain, and burning) will be reported weekly during radiation therapy by patients using a visual analog scale (VAS) (10 cm in length, 0 = no symptoms, 10 = worst possible symptoms). In the analysis VAS recordings will be calculated as sum scores and will be grouped as follows: 0 (no); 1-10 (mild), 11-20 (moderate) and 21-30 (severe symptoms) .
   * Patients evaluation of the treatment satisfaction will be measured by the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G) at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy) .
   * Percentage of patients with secondary skin infection / need of topical and systemic antibiotics during the whole study.
   * Patients' preference to the creams regarding smell, stickiness and easiness to rub out will be recorded using a visual analog scale (VAS) at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy).

   Statistical analysis
   * Statistics of the study population will be described using sums and proportions. Chi-square (χ2) test will be used to calculate effect of treatment on skin reaction for categorical data.
   * A two-tailed P value \< 0.05 will be deemed statistically significant.

Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients

A Comparative Study Between Topical Betamethasone Cream or Topical Olive Oil Cream in Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients.

Patients 'subjective symptoms (itching, pain, and burning) will be reported using a visual analog scale (VAS) (10 cm in length, 0 = no symptoms, 10 = worst possible symptoms). In the analysis VAS recordings will be calculated as sum scores and will be grouped as follows: 0 (no); 1-10 (mild), 11-20 (moderate) and 21-30 (severe symptoms) .

• Percentage of patients with secondary skin infection / need of topical and systemic antibiotics

• Development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score

Patients quality of life will be measured using an Arabic version of a validated questionnaire

Patients evaluation of the treatment satisfaction will be measured by the FACIT-TS-G

Cairo University

Professor, Head of Clinical Pharmacy Department

40 patients on palliative care with grade 2 or grade 3 radiodermatitis after radiotherapy for the treatment of cancer submitted to a PBM therapy protocol

Focal low-level laser therapy, Red Laser (wavelength 633 nm to 685 nm), or Infrared Laser Laser (wavelength 780 nm to 830 nm), with a low-intensity laser equipment of 100 mW and a cross-sectional area of the device beam of 0.0434 cm². The parameters are 1 to 3 J per point, with equidistant points of 1.5 to 2 cm, covering the entire length of the open lesion. Therapy is carried out every 48 hours until the total wound healing, regardless of the number of sessions required.

Rebeca B Cecatto, Ph.D.

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis on Palliative Care, treated with PBM. This is a case series report and the study data will be extracted from the medical records of forty cancer patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of forty cancer patients on palliative care diagnosed with radiotherapy-induced acute radiodermatitis Grade 2or 3, treated with PBM. This is a case series report and the study data will be extracted from the medical records of patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The assessment will be done pre-treatment, weekly during PBM therapy and post-treatment. The PBM therapy are focal low-level laser therapy, 1 to 3 Joules per point, depending on the degree of pain, wavelength 633 to 685 nm, transcutaneously on the surface of the tissue injured by radiotherapy, three times a week during radiotherapy treatment and two more applications after the end of radiotherapy The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.

The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.

The WHOWOL BREF scale assess multidimensional aspects of geral quality of life of patients. The multidimensional scale is composed by 26 items, classified from 1 to 5 according to the intensity of the symptom presented. The global score is calculated by adding up all the items as well as the score for each domain is evaluated adding it individually for each item, which can range from 0 to 130,

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Histamine Antagonists

Dimenhydrinate

Emollients

Will receive the standard institutional skin care for acute radiodermatitis

Will receive the novel, self-prepared skin care product

The emollient has a calming effect, and hydrating and anti-oxidative properties.

An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Hydrating emollient for acute radiodermatitis

The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Standard institutional skin care

Jeroen Mebis, MD, PhD

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT.

Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed.

The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.

Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients

Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics

Novel Skin Care Product for the Management of Acute Radiodermatitis

Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.

The patients skin reactions will be evaluated by the modified version of the RTOG criteria

The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).

The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients	NCT05557825	Radiodermatitis... Radiotherapy Si... Head and Neck C...	Photobiomodulat...	-	University of Nove de Julho
Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients	NCT05285943	Radiodermatitis...	Olive oil cream Betamethasone V... Base Cream	18 Years -	Cairo University
The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients	NCT05557825	Radiodermatitis... Radiotherapy Si... Head and Neck C...	Photobiomodulat...	-	University of Nove de Julho
Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients	NCT05285943	Radiodermatitis...	Olive oil cream Betamethasone V... Base Cream	18 Years -	Cairo University
The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.	NCT05561803	Radiodermatitis... Radiotherapy Si... Cancer Patients Palliative Care	Photobiomodulat...	-	University of Nove de Julho
The Use of Photobiomodulation in the Management of Radiodermatitis in Head and Neck Cancer Patients	NCT05557825	Radiodermatitis... Radiotherapy Si... Head and Neck C...	Photobiomodulat...	-	University of Nove de Julho
Novel Skin Care Product for the Management of Acute Radiodermatitis	NCT04929808	Radiodermatitis... Radiation Derma...	Hydrating emoll... Standard instit...	18 Years -	Jessa Hospital
The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.	NCT05561803	Radiodermatitis... Radiotherapy Si... Cancer Patients Palliative Care	Photobiomodulat...	-	University of Nove de Julho

Spots Global Cancer Trial Database for radiodermatitis; acute