Trial reportBreast cancer (Tokyo, Japan)2025
Prospective randomized-controlled trial: efficacy of 37 °C-preheated thermoplastic elastomer (TPE) bolus in postoperative radiotherapy for breast cancer patients.
Trial report in Breast cancer (Tokyo, Japan), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
16 authors.
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Abstract
objectiveThis randomized-controlled trial aimed to investigate whether preheating thermoplastic elastomer (TPE) bolus to 37 °C reduces setup errors and improves patient comfort during post-mastectomy radiotherapy (PMRT).
methodsFrom July 2023 to June 2024, breast cancer patients requiring PMRT were randomized (1:1) to receive either preheated (37 °C, 30 min) or room-temperature TPE bolus. Bolus was applied during the first half of treatment (15/25 or 8/15 fractions). Weekly cone-beam computed tomography (CBCT) assessed setup errors (lateral [Lat], longitudinal [Lng], vertical [Vrt], and rotational [Rtn]). Secondary endpoints included thorax anteroposterior diameter changes (ΔZ), skin toxicity (CTCAE v3.0), and comfort (modified Likert scale).
resultsAmong 154 analyzed patients, preheating significantly reduced Vrt (0.24 ± 2.43 mm vs. - 0.64 ± 2.46 mm, p < 0.01) and Lat errors (- 0.12 ± 2.49 mm vs. 0.63 ± 2.49 mm, p < 0.01). The preheating group reported higher temperature comfort scores (4.32 ± 0.55 vs. 3.59 ± 0.72, p < 0.01). No significant differences were observed in Grade 2 (46.6% vs. 44.3%, p = 0.661) or Grade 3 (2.7% vs. 2.9%, p = 1.000) radiation dermatitis.
conclusionPreheated TPE bolus improves setup accuracy in the Vrt and Lat directions, enhances patient comfort, and maintains skin safety, supporting its clinical utility in PMRT.
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