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Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer

18 de agosto de 2026 actualizado por: Youssef Hashem Hafez

Topical Boswellia Serrata Roxb. Gum Resin 2% Cream for the Prevention of Radiation-Induced Dermatitis in Head and Neck Cancer Patients

This study evaluates a topical 2% Boswellia serrata (Indian olibanum) gum-resin cream for the prevention of acute radiation-induced dermatitis in patients with head and neck cancer undergoing radiotherapy. Participants in the intervention group apply the cream to the radiation field twice daily throughout the radiotherapy course; the control group receives no preventive topical treatment (rescue treatment only if skin reactions occur). The two co-primary outcomes are the proportion of patients who require rescue treatment (e.g., topical corticosteroids or other topical interventions) for skin reactions, and the proportion whose skin condition is rated "improved" or "in remission" versus "unchanged" or "worsened" on a standardized change-of-condition assessment. Secondary outcomes include time to onset of radiodermatitis, maximal severity (RTOG and CTCAE grading), patient-reported symptoms (pain, itching, burning) and quality of life, radiotherapy interruptions due to skin toxicity, and safety/tolerability.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Background: Acute radiation-induced dermatitis is a common adverse effect in patients undergoing radiotherapy for head and neck cancer, and it can impair quality of life and, when severe, contribute to treatment interruptions. Boswellia serrata gum resin (Indian olibanum) has recognized anti-inflammatory properties, and a topical boswellic-acid cream previously reduced skin-reaction severity and the need for rescue corticosteroids in breast radiotherapy. Evidence in head and neck cancer is lacking.

Objective: To evaluate the efficacy of a 2% Boswellia serrata gum-resin topical cream in preventing or reducing acute radiation-induced dermatitis in head and neck cancer patients undergoing radiotherapy.

Design: Non-randomized (quasi-experimental), open-label, interventional study with two parallel groups. The intervention group applies the 2% Boswellia cream to the radiation field twice daily throughout radiotherapy; the control group receives no preventive topical treatment (rescue treatment only if skin reactions occur). Planned enrollment is 60 participants (about 30 per group), based on an a priori power analysis for the difference in rescue-treatment requirement between groups.

Setting: Alexandria University Main Hospitals and Ayady Almostakbal Hospital, Egypt.

Assessments: Skin toxicity is graded at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 2 and 4 weeks after radiotherapy, using both the RTOG acute radiation morbidity skin score and CTCAE v5.0. Patient-reported pain, itching, and burning (numeric rating scales) and a skin-related quality-of-life instrument are collected. Rescue interventions, adverse events, and radiotherapy interruptions are logged.

Ethics: The study was approved by the Research Ethics Committee, Faculty of Medicine, Alexandria University (serial 0109668; IRB 00012098; FWA 00018699). Written informed consent is obtained from every participant before enrollment.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Egipto
      • Alexandria, Egipto
        • Reclutamiento
        • Alexandria university main hospitals
      • Alexandria, Egipto
        • Reclutamiento
        • Ayady Almostakbal Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

-

Inclusion Criteria:

  • Adults aged 18 years or older, of any sex, with histologically confirmed head and neck cancer for which radiotherapy is indicated
  • Planned external-beam radiotherapy to the head and neck region (curative or adjuvant intent) with a planned total dose of at least 60 Gy; concurrent chemotherapy is permitted
  • Able to provide written informed consent and comply with the protocol (twice-daily cream application, follow-up visits, and a skin diary)
  • Agreement to avoid other topical treatments in the radiation field during the study period (except study-provided or allowed rescue medication)

Exclusion Criteria:

  • Previous radiotherapy to the same site
  • Previous extensive surgery or reconstruction in the head and neck region that substantially alters the radiation field or interferes with skin assessment
  • Known allergy or hypersensitivity to Boswellia serrata, boswellic acids, or any component of the cream base
  • Current use of systemic corticosteroids or anti-inflammatory medications that could influence skin reactions (low-dose corticosteroids as chemotherapy premedication are allowed)
  • Dermatologic conditions in the treatment area that could interfere with assessment (e.g., psoriasis, scleroderma, severe acne, chronic wounds)
  • Pre-existing dermatitis or significant skin lesions in the radiation field at baseline
  • Pregnancy or breastfeeding
  • Any other condition that, in the investigator's judgment, would compromise participation or confound the results

Exclusion Criteria:

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Boswellia 2% Cream
Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.
Droga: Boswellia serrata 2% topical cream
A cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.
Sin intervención: Control (No Preventive Treatment)
No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rescue treatment requirement
Periodo de tiempo: From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)
Proportion of participants who require any rescue medication beyond the study cream to manage skin reactions (most importantly topical corticosteroids, but also oral analgesics, antibiotics, or wound care).
From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)
Improvement in skin condition (change-of-condition assessment)
Periodo de tiempo: At the end of radiotherapy (approximately 7 weeks)
Proportion of participants whose skin condition is rated 'improved' or 'in remission' versus 'unchanged' or 'worsened' on a standardized change-of-condition assessment (adapted from psoriasis/eczema studies) at the end of radiotherapy.
At the end of radiotherapy (approximately 7 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to onset of radiodermatitis
Periodo de tiempo: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Time (days) from the start of radiotherapy to the first occurrence of a grade 1 or higher skin reaction (RTOG/CTCAE).
From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Maximum severity of radiodermatitis
Periodo de tiempo: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Highest radiodermatitis grade recorded during the study, assessed using the RTOG acute radiation morbidity skin score and CTCAE v5.0.
From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Patient-reported skin symptoms
Periodo de tiempo: Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Weekly patient-reported pain, itching, and burning of the treated skin, each rated on a 0-10 numeric rating scale.
Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Radiotherapy interruptions due to skin toxicity
Periodo de tiempo: During radiotherapy (approximately 7 weeks)
Number and duration (days) of radiotherapy interruptions or missed fractions attributable to skin toxicity.
During radiotherapy (approximately 7 weeks)
Incidence of adverse events (safety and tolerability)
Periodo de tiempo: From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
Incidence of local and systemic adverse events, including allergic contact dermatitis, associated with daily application of the study cream.
From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Youssef Hashem Hafez

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de agosto de 2026

Finalización primaria (Estimado)

1 de octubre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

18 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de agosto de 2026

Publicado por primera vez (Actual)

21 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BOSWELLIA-RD-HNC-2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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