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

18. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Ägypten
      • Alexandria, Ägypten
        • Rekrutierung
        • Alexandria university main hospitals
      • Alexandria, Ägypten
        • Rekrutierung
        • Ayady Almostakbal Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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:

-

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Boswellia 2% Cream
Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.
Arzneimittel: 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.
Kein Eingriff: Control (No Preventive Treatment)
No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rescue treatment requirement
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to onset of radiodermatitis
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Youssef Hashem Hafez

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. August 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

18. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. August 2026

Zuerst gepostet (Tatsächlich)

21. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BOSWELLIA-RD-HNC-2026

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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