Clinical trial · Interventional
Exploratory Trial of SAT-003 in Cancer Cachexia Patients With Discontinued Chemotherapy
A Single Center, Single Arm, Prospective , Exploratory Clinical Trial to Evaluate the Validity, Safety and Efficacy of SAT-003 in Cancer Cachexia Patients Discontinued Chemotherapy Who Had Diagnosed With Solid Cancer
NCT06476197CI-TRIAL-00092250completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial aims to evaluate the feasibility of 'SAT-003' as well as its exploratory safety and efficacy in patients with cancer cachexia who have been diagnosed with solid tumors and have discontinued anticancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAT-003 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAT-003 Treatment arm(Single arm)
- description
- 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.
- interventionNames
- Device: SAT-003
Primary outcomes (9)
- measure
- Change in Karnofsky Performance Status(KPS)score
- timeFrame
- Baseline, 6weeks, 12weeks, 18weeks, 24weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged 19 years and older 2. Cancer cachexia patients diagnosed with solid tumors and whose anticancer treatments (surgery, radiation therapy, anticancer drugs, or chemotherapy) have been discontinued. (Diagnosis criteria for cancer cachexia include: experiencing a weight loss of 5% or more over the past 6 months, having a BMI below 20 with a weight loss exceeding 2%, or having a skeletal muscle index indicative of sarcopenia (for males \< 7.26 kg/m\^2; for females \< 5.45 kg/m\^2) with a weight loss exceeding 2% 3. between 20 and 70 points of KPS score 4. Capable of holding and raising a smartphone with the treatment application installed 5. Capable of either listening or viewing, and able to move parts of their body 6. Capable of using a smartphone and application by themselves or with assistance from caregiver or guardian (In the latter case, the availability of assistance from a caregiver or guardian shoud be confirmed.) Exclusion Criteria: 1. have pledged discontinue further anticancer treatment 2. Those whose chemotherapy or radiation therapy has already been confirmed prior to enroll 3. lack the cognitive ability to understand and adhere the instructions
References
Publications (0)
Data not yet available
No reference posted for this study.