NSCLC
Conditions
Interventions
Perform cryocompression therapy of the extremities.
Sponsors
Shonan Fujisawa Tokushukai Hospital, Respiratory medicine, Makoto Hibino
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with non-small cell lung cancer based on cytology/histology. 2) Incurable stage III/IV disease or recurrence after curative therapy (surgery, chemoradiotherapy, or radiation therapy alone). 3) No prior chemotherapy (prior use of non-cytotoxic agents such as tyrosine kinase inhibitors is allowed). Cases that received adjuvant chemotherapy or chemoradiotherapy are eligible if the regimen does not include taxanes and the last administration of the final chemotherapy occurred at least 6 months prior to the registration in this trial. 4) Japanese nationals aged 18 years or older (gender is not specified). 5) Study subjects who have received sufficient explanation and have provided written consent of their own free will. 6) Planned treatment regimen includes the following therapy consisting of CBDCA + taxane-based chemotherapy + immune checkpoint inhibitors: a) KEYNOTE407 regimen: Non-small cell squamous carcinoma lung cancer CBDCA + Nab-Paclitaxel + Pembrolizumab or CBDCA + Paclitaxel + Pembrolizumab b) IMpower150 regimen: Non-small cell non-squamous carcinoma lung cancer CBDCA + Paclitaxel + Bevacizumab + Atezolizumab c) IMpower130 regimen: Non-small cell non-squamous carcinoma lung cancer CBDCA + Nab-Paclitaxel + Atezolizumab d) POSEIDON regimen: Non-small cell lung cancer CBDCA + Nab-Paclitaxel + Durvalumab + Tremelimumab
Exclusion criteria
Exclusion criteria: 1) Presence of peripheral neuropathy with self-reported symptoms (Common Terminology Criteria for Adverse Events: CTCAE grade 2 or higher), excluding those caused by systemic conditions such as diabetes, connective tissue diseases, uremia, vitamin B1 deficiency, cervical or lumbar spondylosis, etc. Objective tests, such as nerve conduction velocity, are not mandatory for excluding peripheral neuropathy. 2) History of Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy. 3) Presence of tumor-related neuropathy. 4) Presence of cognitive impairment or consciousness disturbance preventing completion of the EORTC QLQ-CIPN20 questionnaire. 5) Presence of open wounds or ulcers in the limbs. 6) Severe peripheral arterial disease. 7) Poorly controlled diabetes (HbA1c > 8.0%) at screening. 8) History of Raynaud's phenomenon. 9) Intolerance to cold. 10) Other reasons determined by the principal investigator that render the patient unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of CIPN at any grade (CTACAE ver. 5.0) | — |
Countries
Japan
Contacts
Public ContactHibino Makoto
Shonan Fujisawa Tokushukai Hospital Respiratory medicne
Outcome results
None listed