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. 2023 Jul 7:13:1216813.
doi: 10.3389/fonc.2023.1216813. eCollection 2023.

Mitigation of paclitaxel-induced peripheral neuropathy in breast cancer patients using limb-cooling apparatus: a study protocol for a randomized controlled trial

Chikako Funasaka  1   2 , Akiko Hanai  3 , Sadamoto Zenda  4   5 , Keita Mori  6 , Makoto Fukui  7 , Nami Hirano  7 , Rie Shinohara  7 , Nozomu Fuse  7 , Masashi Wakabayashi  7 , Mai Itagaki  8 , Yutaka Tomioka  9 , Michihiko Nishina  10 , Yasuaki Arai  11 , Takahiro Kogawa  12 , Yukinori Ozaki  12   13 , Meiko Nishimura  13 , Takayuki Kobayashi  13 , Fumikata Hara  13 , Toshimi Takano  13 , Toru Mukohara  1
Affiliations

Mitigation of paclitaxel-induced peripheral neuropathy in breast cancer patients using limb-cooling apparatus: a study protocol for a randomized controlled trial

Chikako Funasaka et al. Front Oncol. .

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common adverse events that can significantly impair the quality of life of patients. Although limb cooling may be beneficial for preventing CIPN, logistical challenges exist in ensuring consistent efficacy and safety. The purpose of this randomized controlled trial is to validate whether limb cooling with strict temperature control can reduce CIPN in patients with breast cancer receiving weekly paclitaxel as a perioperative treatment.

Methods: This study is a multicenter, double-blinded, randomized controlled trial. We plan to enroll patients with breast cancer who are scheduled to receive 12 weekly doses of paclitaxel (60 min 80 mg/m2 intravenous infusion) as perioperative chemotherapy. Patients will be randomly divided into the intervention or control groups and undergo limb cooling therapy maintained at a constant temperature of 13°C and 25°C, respectively. The primary endpoint is the proportion of patients who report Patient Neurotoxicity Questionnaire (PNQ) ≥ D in their limbs by the end of the study treatment or at the time of discontinuation.

Discussion: The results of this trial will contribute to the establishment of new evidence for limb cooling therapy in the mitigation of CIPN and present a safe and stable cooling device that may be suitable for use in the clinic.

Clinical trial registration: https://jrct.niph.go.jp/en-latest-detail/jRCT2032210115, identifier jRCT2032210115.

Keywords: breast cancer; chemotherapy induced peripheral neuropathy; circulation cooling system; limb cooling therapy; paclitaxel.

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Conflict of interest statement

Author MiN was employed by the company Sigmax Co, Ltd. Outside of the current manuscript: TM has received research funding from Daiichi-Sankyo, Sysmex, MSD, Pfizer, Sanofi, and Chugai Pharmaceutical. AH has received lecture fees from Eisai, Daiichi-Sankyo, Kaken Pharmaceutical, and Ono Pharmaceuticals. AH is also the chief of JASCC’s CIPN guidelines. MW received an honorarium from Nihon Media Physics, Japan. KM received honoraria for lecturing from Chugai Pharmaceuticals, Ono Pharmaceutical, Daiichi-Sankyo, and Eli Lilly. YO received honoraria from Daiichi Sankyo, Kyowa Kirin, Pfizer, Chugai, and Eli Lilly. TT received honoraria from Daiichi Sankyo, Chugai, and Eli Lilly. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Nippon Sigmax Co, Ltd. The funder had the following involvement in the study: providing medical equipment, planning the study, and the decision to submit it for publication. The funder was not involved in the trial, the interpretation of the results, or anything else related to its conduct.

Figures

Figure 1
Figure 1
Schematic overview of the CECILIA trial.
Figure 2
Figure 2
Illustration of the Icing System (CE4000) apparatus provided by Nippon Sigmax. (A) The parts of the CE4000 cooling system, including the main unit, cord, and power cord. (B) The gloves (right) and socks (left) to be worn by patients 15 min before the treatment is initiated, during the 60 min PTX treatment, and until 15 min after the treatment is completed.
See this image and copyright information in PMC

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