Exploratory Clinical Trial to Safety and Efficacy of SAT-003 in Cancer Cachexia Patients Discontinued Chemotherapy Who Had Diagnosed With Solid Cancer
NCT Number: NCT06476197
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cancer Cachexia
Interventions: DEVICE: SAT-003
Sponsor: S-Alpha Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-15
Completion Date: 2024-12-30
Locations: Dongkuk University Ilsan Hospital, Gyeonggi-do, Korea, Republic of

Summary:
Although various studies and treatments for cachexia are being attempted, there is currently no definitive treatment that can improve cancer cachexia symptoms. Nutritional therapy for anorexia, which is a primary symptoms of cachexia, and medicatio therapy to improve appetite have limitations in effectively alleviating the overall symptoms of cachexia. Cachexia initially manifests with symptoms such as loss of appetite and weight loss, and gradually progresses skeletal muscle loss, eventually leading to systemic dysfunction. Consequently, there is a steady increase in the development of related treatments.

SAT-003 provides various activities aimed at improving the symptoms of cancer cachexia, with the ultimate goal of resuming discontinued chemotherapy.

Primary Outcome Measures: Change in Karnofsky Performance Status, The KPS assessment is a scale that evaluates the process of patient's recovery to daily life after treatment. It rates the worst state of inability to function as 0 and the normal state as 100. A higher score indicates a better outcome., Baseline, 6weeks, 12weeks, 18weeks, 24weeks|Change in EORTC QLQ-C30 score, The EORTC QLQ-C30 consists of 30 items, rated on a scale of 0 to 100, across three domains: overall quality of life, functional scale, and symptom scale of cancer patients.

Higher scores for the overall quality of life and functional scale indicate higher quality of life, implying better outcomes, while higher scores for the symptom scale indicates lower quality of life, implying a worse outcome., Baseline, 6weeks, 12weeks, 18weeks, 24weeks|Chagne in Korean Modified Barthel Index Score, The K-MBI is an index to evaluate the patient's performance of activities of daily living, rated on a scale of 0 to 100. A score of 100 represents a normal state without the need for assistance in daily living and the score decreases as the patient needs help from others. A higher score indicates a lower level of impairment, reflecting a better outcome., Baseline, 6weeks, 12weeks, 18weeks, 24weeks|Change in Grip Strength (lbs), Using a dynamometer, change and rates of change in Grip Strength (hand grip, pinch grip, lateral prehension, and three-jaw chuck) are assessed. The results are evaluated as the average value of each hand., Baseline, 6weeks, 12weeks, 18weeks, 24weeks|Rate of Change (%) in Grip Strength (lbs), Baseline, 6weeks, 12weeks, 18weeks, 24weeks|Change in Lean Body Mass and Rate of Change (%), The change and rates of change in LBM over time is evaluated. Evaluate the amount and rate of change in lean body mass according to the time frame., 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 at 12 and 24 weeks, 24weeks|Chemotherapy Resumption period(days), The evaluate the duration from application SAT-003 to resumption of chemotherapy., 24weeks