Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients

Titre officiel

A Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment

Sommaire:

Les patientes atteintes d’un cancer du sein qui suivent une radiothérapie adjuvante ont souvent des réactions cutanées radio-induites qui ont des effets négatifs sur leur qualité de vie. Il est important de noter que les patientes qui reçoivent une radiothérapie thoracique ou les patientes ayant une forte poitrine sont plus susceptibles d’avoir des réactions cutanées plus graves. Au cours de la dernière décennie, aucun progrès important n’a été réalisé en matière de prévention ou de traitement des toxicités cutanées radio-induites. En réponse au manque de données, les chercheurs de Sunnybrook ont précédemment mené une étude pilote (REB no 294-2018) sur le pansement Mepitel Film, et les résultats préliminaires ont montré des améliorations dans les réactions cutanées de grade élevé. Le pansement Mepitel Film n’a pas été largement adopté en Amérique du Nord, car des données probantes supplémentaires sont nécessaires. Une étude visant à évaluer l’efficacité du pansement Mepitel Film par rapport à celle des pansements recommandés par le protocole thérapeutique standard est proposée. Dans le cadre de l’étude, 216 patientes seront réparties au hasard (2:1) pour recevoir soit le pansement Mepitel Film soit les traitements cutanés courants utilisés par l’établissement, et la peau de toutes les patientes sera évaluée.

Description de l'essai

Primary Outcome:

  • Number of participants with treatment-related radiation-induced skin toxicity as assessed by the CTCAE v.5.0.
Secondary Outcome:
  • Number of participants with acute radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.
  • Number of participants with acute radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.
  • Number of participants with late radiation-induced skin toxicities as assessed by a healthcare provider using the CTCAE v5.0.
  • Number of participants with late radiation-induced skin toxicities as assessed by the participant using the CTCAE v5.0.
  • Number of participants with reconstruction complications as assessed by the BREAST-Q PROMS modules for breast-conserving therapy and reconstruction.

Breast cancer patients undergoing adjuvant radiation therapy commonly experience radiation-induced skin toxicities which adversely impact patients' quality of life. These skin toxicities may present in the form of acute reactions including erythema, pruritus or moist desquamation and late toxicities in the form of hyperpigmentation or fibrosis. The development of severe skin toxicities may result in treatment interruptions or increase the risk of reconstructive complications. Importantly, patients receiving radiation therapy to the chest wall or patients with larger breast size are more likely to have more severe skin reactions. In the last few decades, there have been no significant advances in preventing or treating radiation-induced skin toxicities.

A phase III randomized trial was conducted by Herst et al. (n=78) in New Zealand which showed that the prophylactic use of Mepitel Film prevented moist desquamation (26% vs. 0%, p < 0.001) and reduced skin reaction severity by 92% (p < 0.001) compared to skin treated only with aqueous cream. Mepitel Film has not been adopted in routine practice in North America as more convincing proof may be needed from international multi-centre trials to influence changes in standard clinical practice guidelines. A phase II feasibility study has recently been completed at Sunnybrook Odette Cancer Centre and the preliminary results have shown reductions in severe skin reactions.

Mayo Clinic has also completed a phase II pilot study which, like the feasibility study conducted at our centre, yielded promising results. The Alliance trial group in the US is planning for a phase III multi-centre trial for post-mastectomy patients receiving conventional radiation treatment. As the Alliance trial is only enrolling post-mastectomy patients receiving conventional radiation therapy, our study will additionally investigate outcomes for post-mastectomy patients receiving hypofractionated radiation treatment. Additionally, the investigators will be enrolling patients with large breasts [bra size 36 in and/or C cup or greater] as these patients are at known risk for developing increased acute skin toxicities.

A randomized controlled trial is a critical next step in establishing whether Mepitel Film reduces acute and long-term skin toxicity in post-mastectomy and large breasted patients and in order for it to become standard of care in breast radiation therapy. This study plans to enroll 216 patients in a 2:1 ratio (2 Mepitel Film: 1 institutional standard of care).

The primary objective is to compare the efficacy of Mepitel Film versus the institutional standard of care in reducing the severity of radiation dermatitis in patients undergoing whole breast or chest wall radiation therapy. Secondary objectives include an evaluation of patient-reported and healthcare professional (HCP)-reported skin toxicities including moist desquamation with the use of Meptiel Film.

Radiation oncologists will first introduce the study to their patients in their breast clinic, showing a sample of the product and also pictures from the trial conducted in New Zealand. Patients if interested may be provided a patient information sheet to review at home. Then, patients will be approached by a CRA at their radiation planning appointment to review all information and obtain informed consent.

For patients randomized to the Mepitel Film arm, patients will receive the film for the entire duration of treatment. Radiation treatment will be delivered as prescribed by the treating radiation oncologist irrespective of study arm and may include a variety of techniques and beam modifiers.

Voir cet essai sur ClinicalTrials.gov

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