The clinical effect of an electric massage chair on chemotherapy-induced nausea and vomiting in cancer patients: randomized phase II cross-over trial

INTERVENTION: Others(Electric massage chair) : This study was designed as an open‐label, phase 2 clinical trial conducted at the Korea University Anam Hospital. Between June 2020 and July 2021, solid cancer patients scheduled to receive HEC or MEC for the first time in their life were screened. Those who had disseminated or extensive bone metastasis or were taking anticoagulant agents were excluded. When the patients met all the inclusion and exclusion criteria, they were enrolled in the study and randomized into two groups: Group A or Group B. Patients in Group A received chemotherapy on a general ward bed, while those in Group B received chemotherapy in an EMC during the first cycle of treatment. At the 2nd cycle of chemotherapy, participants crossed the other group. We assumed that at least 10 days after receiving an EMC treatment was enough to wash out the clinical effect of massage, and that there might be no carry‐over effect on the next cycle of chemotherapy. Standard prophylactic antiemetics were prescribed according to each chemotherapy regimen, and rescue medicines were also added according to patients’ needs and investigators’ decisions. Acute CINV was evaluated on the second day of each chemotherapy cycle according to the CTCAE v5.0 [9]. Information regarding rescue medication for CINV and QoL surveillance was also collected. The study protocol was reviewed and approved by the Institutional Review Board of Korea University Anam Hospital (No. 2020AN0054). CONDITION: Neoplasms PRIMARY OUTCOME: INVR SECONDARY OUTCOME: complete response rate EORTC‐QLQ‐C30 INCLUSION CRITERIA: ‐20 years old or older ‐Patients with histologically confirmed solid tumors ‐Patients receiving chemotherapy for the first time in their lives ‐Patients who are planned to receive HEC/MEC as defined in the NCCN guideline 2019‐2020 ‐ECOG PS 0‐2 ‐ defined as having appropriate cardiac and renal function as follows: a. Hemoglobin = 8.0 g/dL b. Absolute neutrophil count = 1.0 X10^9/L c. Platelet count = 75 X10^9/L d. Serum bilirubin = 1.5 XULN e. AST/ALT = 2.5 XULN f. Creatinine clearance calculated by the Cockcroft‐Gault formula > 50 mL/min