Exploratory Trial of SAT-003 in Cancer Cachexia Patients With Discontinued Chemotherapy

NCT06476197 | Completed

• 1 other identifier: SAT003-KP-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer Cachexia

Outcome Measures

Primary Outcomes (9)

• Change in Karnofsky Performance Status(KPS)score

  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.

  Baseline, 6weeks, 12weeks, 18weeks, 24weeks

• Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score

  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.

  Baseline, 6weeks, 12weeks, 18weeks, 24weeks

• Chagne in Korean Modified Barthel Index (KBMI) Score

  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).

  Baseline, 6weeks, 12weeks, 18weeks, 24weeks

• Change in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)

  The change in Grip Strength (Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) were 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. \*Handgrip strength was measured using a JAMAR Hydraulic Hand Dynamometer, and pinch strength was measured using a JAMAR Hydraulic Pinch Gauge. Hand grip, Pinch grip, Lateral prehension, and Three jaw chuck are measured using a handgrip dynamometer and pinch gauge. Before performing each item, the assessor explains and demonstrates the task to the subject. The subject attempts each hand three times, with a rest period after each attempt. The results are evaluated as the average value for each hand.

  Baseline, 6weeks, 12weeks, 18weeks, 24weeks

• Rate of Change (%) in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)

  The change rate in Grip Strength (Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) were 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. \*Handgrip strength was measured using a JAMAR Hydraulic Hand Dynamometer, and pinch strength was measured using a JAMAR Hydraulic Pinch Gauge. Hand grip, Pinch grip, Lateral prehension, and Three jaw chuck are measured using a handgrip dynamometer and pinch gauge. Before performing each item, the assessor explains and demonstrates the task to the subject. The subject attempts each hand three times, with a rest period after each attempt. The results are evaluated as the average value for each hand.

  Baseline, 6weeks, 12weeks, 18weeks, 24weeks

• Change in Lean Body Mass(LBM) and Rate of LBM Change (%)

  The change and change rate in Lean Body Mass (LBM) were 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. \*LBM is measured according to the institution's standard procedures using Dual Energy X-ray Absorptiometry (DEXA).

  Baseline, 6weeks, 12weeks, 18weeks, 24weeks

• Survival Rate (%) at 24 weeks

  The proportion of surviving subjects who survived up to 24 weeks after enrollment is evaluated. To assess the proportion of subjects surviving to 24 weeks after the date of enrollment.

  Baseline, 24weeks

• Chemotherapy Resumption Rate(%)

  The proportion of patients who resumed chemotherapy and the time (days) elapsed until chemotherapy resumption are evaluated at Week 12 (Visit 8) and Week 24 (Visit 9) post-treatment

  12 weeks, 24weeks

• Chemotherapy Resumption period(days)

  The evaluate the duration from application SAT-003 to resumption of chemotherapy.

  24weeks

Secondary Outcomes (2)

• Adherence Assessment During the Treatment Period

  Baseline, Week12, through study completion, an average of 24 weeks

• Change in Number of External Activity Performances

  Baseline, Week12, through study completion, an average of 24 weeks

Other Outcomes (1)

• Adverse Events

  through study completion, an average of 24 weeks

Study Arms (1)

SAT-003 Treatment arm(Single arm)

EXPERIMENTAL

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

Interventions

SAT-003 DEVICE

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

SAT-003 Treatment arm(Single arm)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 19 years and older
• 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%
• between 20 and 70 points of KPS score
• Capable of holding and raising a smartphone with the treatment application installed
• Capable of either listening or viewing, and able to move parts of their body
• 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.)

You may not qualify if:

• have pledged discontinue further anticancer treatment
• Those whose chemotherapy or radiation therapy has already been confirmed prior to enroll
• lack the cognitive ability to understand and adhere the instructions

Sponsors & Collaborators

• S-Alpha Therapeutics, Inc.: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Ilsan, Gyeonggi-do, 10326, South Korea

Location

Study Officials

• Dalyong Kim, M.D., Ph.D

  DongGuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 26, 2024
• Study Start: July 11, 2023
• Primary Completion: August 30, 2024
• Study Completion: April 3, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-06

Locations

KR (1)