Arm Name: SAT-003 Treatment Arm

Intervention:

• Type: Software Device (Rehabilitation Medicine Software, E10000, Class 2 Medical Device)
• Name: SAT-003
• Details: Participants will use the SAT-003 software daily 10 mins at most/ for 12 weeks. Specific usage instructions and session duration will be provided according to the protocol.

Arm Description: This is a single-arm, prospective exploratory clinical trial. All participants, who are patients with cancer cachexia diagnosed with solid tumors and having discontinued chemotherapy, due to cancer cachexia, will receive the investigational medical device, SAT-003. The primary objective of this arm is to evaluate the feasibility of safety, and preliminary efficacy of SAT-003. Participants will undergo specified assessments at Baseline, Week 6, Week 12, and Week 24 to monitor their progress and potential adverse events. No control group or comparative intervention will be administered in this study.

Device: SAT-003(Software) Using SAT-003 for 12 weeks

The change in the Karnofsky Performance Status (KPS) score was evaluated from Baseline (Visit 2) to Week 6 (Visit 5) and Week 12 (Visit 8) post-treatment, and also from Week 6 (Visit 5) to Week 12 (Visit 8) post-treatment.

The KPS score is a scale used to assess a patient's recovery process to daily living after treatment. A score of 0 indicates the worst, non-functional state, while 100 represents a normal state.

The change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score was evaluated from Baseline (Visit 2) to Week 6 (Visit 5) and Week 12 (Visit 8) post-treatment, and also from Week 6 (Visit 5) to Week 12 (Visit 8) post-treatment.

The EORTC QLQ-C30 is a 30-item questionnaire composed of three domains: global health status/quality of life, functional scales, and symptom scales. The global health status is assessed by 2 items, while the functional scales consist of 15 items evaluating physical, role, cognitive, emotional, and social functioning. The symptom scales include 2-3 items for fatigue, pain, and nausea/vomiting, and single items for dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. Scores range from 0 to 100. Higher scores for global health status and functional scales, and lower scores for symptom scales, indicate a better quality of life.

The change in the Korean Modified Barthel Index (KMBI) score was evaluated from Baseline (Visit 2) to Week 6 (Visit 5) and Week 12 (Visit 8) post-treatment, and also from Week 6 (Visit 5) to Week 12 (Visit 8) post-treatment.

The K-MBI is an indicator used to assess a patient's performance in activities of daily living (ADL). A score of 100 represents a normal state requiring no assistance with daily activities, and the score decreases as more assistance is needed (refer to Appendix 4. Korean version of Modified Barthel Index Questionnaire).

Adherence to device use, measured by the number of sessions performed within the specified period, is evaluated weekly from Baseline (Visit 2) to Week 12 (Visit 8) post-treatment.

Adverse events are classified into those occurring before the application of the investigational medical device and those occurring after its application (referred to as Treatment Emergent Adverse Events, TEAEs). Adverse events that occurred before the application of the investigational medical device is recorded as pre-treatment adverse events but is excluded from the adverse event analysis. In other words, the adverse event analysis focused solely on TEAEs. However, signs and symptoms arising from the progression of the underlying disease (cancer and cancer cachexia) is not considered adverse events or serious adverse events. Furthermore, for fluctuations in symptoms commonly occurring due to the underlying disease, the investigator determine whether they constituted an adverse event after considering the patient's health status and other factors.