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

18 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Locais de estudo

  • Egito
      • Alexandria, Egito
        • Recrutamento
        • Alexandria university main hospitals
      • Alexandria, Egito
        • Recrutamento
        • Ayady Almostakbal Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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:

-

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Boswellia 2% Cream
Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.
Medicamento: 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.
Sem intervenção: Control (No Preventive Treatment)
No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rescue treatment requirement
Prazo: 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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time to onset of radiodermatitis
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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

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Patrocinador

Youssef Hashem Hafez

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de agosto de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de agosto de 2026

Primeira postagem (Real)

21 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BOSWELLIA-RD-HNC-2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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