Advanced lung cancer
Conditions
Interventions
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 cooli
Sponsors
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital Department of Respiratory Medicine Yasuhiro Nakajima
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with advanced lung cancer who are receiving first-line chemotherapy containing taxane-based anticancer agents at one of 5 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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Common Terminology Criteria for Adverse Events (CTCAE) v6.0 CIPN grade assessment 12 weeks after completion of chemotherapy, including taxane-based anticancer agents | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Common Terminology Criteria for Adverse Events (CTCAE) v6.0 CIPN grade assessment at the start of each cycle (Day 1) 2. Numerical Rating Scale (NRS) assessment at the start of each cycle (Day 1) 3. Incidence of adverse events 4. Rate of chemotherapy dose reduction or discontinuation due to CIPN 5. Assessment of the European Organisation for Research and Treatment on Cancer (EORTC) QLQ-CIPN20 score at the end of chemotherapy containing taxane-based anticancer agents 6. Assessment of the European Organisation for Research and Treatment on Cancer (EORTC) QLQ-CIPN20 score 12 weeks after the end of chemotherapy containing taxane-based anticancer agents | — |
Countries
Japan
Contacts
Public ContactYasuhiro Nakajima
Social Medical Corporation St. Francis Society Himeji St. Mary's Hospital Department of Respiratory Medicine
Outcome results
None listed