Wakolbinger-Habel Robert, Reinweber Matthias, Alakraa Mahmoud, Riener Ingrid, Scheffold Brigitte Elisabeth, Racz Krisztina, Selimi Flonza, Straub Claudia, Jauker Jakob, Bily Walter, Niedersüß-Beke Dora, Mayrhofer Karl, Paternostro-Sluga Tatjana
Department of Physical and Rehabilitation Medicine (PRM), Vienna Healthcare Group-Clinic Donaustadt, Langobardenstraße 122, 1220, Vienna, Austria.
External Lecturer, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Support Care Cancer. 2024 Jan 27;32(2):134. doi: 10.1007/s00520-024-08331-7.
Most oncologic patients receiving chemotherapy suffer from neuropathy, which not only severely affects quality of life but also may lead to chemotherapy dose reductions or even discontinuation of cancer therapy. Still, it is difficult to sufficiently control these symptoms with the currently available pharmacological treatments. High tone therapy was reported to be an effective option for neuropathies due to different etiologies. However, to date, there are no studies on high tone therapy in patients with chemotherapy-induced peripheral neuropathy.
This randomized, double-blind, and placebo-controlled two-center study was conducted at the Departments of Physical and Rehabilitation Medicine at the Clinics Donaustadt and Ottakring, Vienna, Austria. Patients with histologically verified colorectal carcinoma treated with a platin derivate and neuropathic symptoms were invited to participate. High tone therapy took place in a home-based setting using the HiToP 191 PNP ® or placebo device for three weeks. Neuropathic symptoms and quality of life were assessed via questionnaires. After the follow-up examination, an opt-in was offered to the patients in the placebo group in terms of an open-label treatment with a verum HiToP PNP ® device. In addition, patients with chemotherapy-induced peripheral neuropathy due to various malignant diseases were treated in an open-label setting reflecting a clinical application observation. These patients are reported as a separate group.
In the verum group, there was a significant reduction of paresthesias and mental stress due to paresthesias from baseline until end of therapy, compared to placebo. These findings were observed in the opt-in subgroup, as well. In the open-label clinical application observation group, intensity and mental stress due to paresthesia, pain, cramps, and intensity of tightness/pressure were significantly lower at the end of therapy, compared to baseline.
Home-based high tone therapy brought about a significant alleviation in paresthesias and mental stress due to paresthesias in the verum but not the placebo group. In the clinical application observation, a significant alleviation in several further neuropathic symptoms was seen.
This study was registered at clinicaltrials.gov (NCT06048471, 03/02/2020).
大多数接受化疗的肿瘤患者患有神经病变，这不仅严重影响生活质量，还可能导致化疗剂量减少甚至癌症治疗中断。然而，目前可用的药物治疗仍难以充分控制这些症状。据报道，高音疗法是治疗因不同病因引起的神经病变的有效选择。然而，迄今为止，尚无关于高音疗法治疗化疗引起的周围神经病变患者的研究。
这项随机、双盲、安慰剂对照的两中心研究在奥地利维也纳多瑙斯塔特诊所和奥托克林诊所的物理和康复医学科进行。邀请经组织学证实接受铂类衍生物治疗且有神经病变症状的结直肠癌患者参与。高音疗法在家庭环境中使用HiToP 191 PNP®或安慰剂设备进行，为期三周。通过问卷评估神经病变症状和生活质量。随访检查后，向安慰剂组患者提供选择加入使用真HiToP PNP®设备进行开放标签治疗的机会。此外，对因各种恶性疾病导致化疗引起的周围神经病变的患者在反映临床应用观察的开放标签环境中进行治疗。这些患者作为一个单独的组进行报告。
与安慰剂相比，在真治疗组中，从基线到治疗结束，感觉异常以及因感觉异常引起的精神压力显著降低。在选择加入的亚组中也观察到了这些结果。在开放标签临床应用观察组中，与基线相比，治疗结束时因感觉异常、疼痛、痉挛以及紧绷/压力强度引起的强度和精神压力显著降低。
家庭式高音疗法使真治疗组而非安慰剂组的感觉异常以及因感觉异常引起的精神压力得到显著缓解。在临床应用观察中，还发现几种其他神经病变症状得到显著缓解。
本研究在clinicaltrials.gov注册（NCT06048471，2020年2月3日）。
