Clinical Trial: A Clinical Trial to Evaluate the Efficacy of Combining Cooling Therapy and Compression Therapy in Alleviating Taxane-Induced Peripheral Neuropathy in Patients with Non-Small Cell Lung Cancer (Japan)

Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061124) titled 'Evaluation of the Preventive Effects of Combined Cooling and Compression Therapy on Chemotherapy-Induced Peripheral Neuropathy (CIPN) Caused by Chemotherapy for Lung Cancer Using Taxane-Based Anticancer Drugs' on April 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital Department of Respiratory Medicine Yasuhiro Nakajima

Condition: Condition - Advanced lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Evaluation of the Preventive Effects of Combined Cooling and Compression Therapy on Chemotherapy-Induced Peripheral Neuropathy Caused by Taxane-Based Chemotherapy for Lung Cancer Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In the intervention group, compression therapy using surgical gloves and cooling therapy using frozen gloves were administered to the hands, while compression therapy using elastic stockings and cooling therapy using frozen socks were administered to the lower limbs, from 30 minutes before to 30 minutes after each course of taxane-based anticancer drug administration.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients with advanced lung cancer who are receiving first-line chemotherapy containing taxane-based anticancer agents at one of six facilities in the Harima region, including Himeji St. Mary's Hospital, during the period from the date of study approval through March 31, 2028 (For the purposes of this study, taxane-based anticancer agents refer to paclitaxel or nab-paclitaxel, which are used as standard first-line treatments for lung cancer) 2. Patients aged 18 years or older 3. Patients who can provide informed consent to participate in the trial of their own free will 4. Patients with an ECOG Performance Status of 0 or 1 5. Patients with a life expectancy of six months or more Key exclusion criteria - 1.Patients who declined to participate in this study 2.Patients deemed unsuitable for this study by the principal investigator 3.Patients with limb amputations 4.Patients with peripheral neuropathy due to comorbid conditions such as poorly controlled diabetes, autoimmune neuropathies (e.g., Guillain-Barre syndrome, Fisher syndrome, chronic inflammatory demyelinating polyneuropathy), or cerebrovascular disorders accompanied by incomplete or complete paralysis 5.Patients who have undergone major surgery (surgery requiring spinal anesthesia such as general anesthesia or epidural analgesia, surgery requiring cranial trepanation, or tumor resection, etc.) within 4 weeks prior to obtaining informed consent. However, patients who underwent central venous (CV) port placement within 2 weeks prior to enrollment will not be excluded 6.Patients with a history of trauma or surgery to the fingers or toes within 4 weeks prior to obtaining informed consent 7.Plans to initiate or increase the dosage of the following medications during the study period: Duloxetine, pregabalin, gabapentin, milogabalin, sodium valproate, phenobarbital, phenytoin, clonazepam, lidocaine, Goshajinkigan, Bushisueki 8.Currently receiving any of the following medications for symptoms other than CIPN: Duloxetine, pregabalin, gabapentin, milogabalin, sodium valproate, phenobarbital, phenytoin, clonazepam, lidocaine, Goshajinkigan, Bushisueki 9.Participating in clinical trials for other pharmaceuticals or medical devices 10.History of or concurrent mental disorders (alcohol dependence, substance abuse, mood disorders, anxiety disorders, dementia) 11.Women who wish to become pregnant, or women who are pregnant or breastfeeding (a pregnancy test must be performed if there is a possibility of pregnancy) Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069945

Disclaimer: Curated by HT Syndication.