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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Karnofsky Performance Status(KPS)score
研究概览
简要总结
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.
详细描述
Cancer cachexia, characterized by weight loss, anorexia, and muscle wasting, is a metabolic imbalance resulting from impaired endocrine function. Unlike simple hunger or loss of appetite, cancer cachexia leads to a reduction in weight and skeletal muscle metabolism despite normal food intake, progressively weakening the body's overall function. Many cancer patients experience this condition, which can increase resistance to cancer treatment, worsen overall health, and diminish quality of life, often leading to the discontinuation of therapy. Cancer cachexia is a common complication in cancer patients and is associated with high mortality rates. Despite ongoing research, no effective treatment for cancer cachexia has been identified, and current therapies targeting appetite improvement or nutritional support often fail to effectively address the full spectrum of symptoms. SAT-003 has been developed to alleviate the symptoms of cancer cachexia and facilitate the resumption of cancer treatment. This single-center, single-arm, prospective feasibility clinical trial aims to evaluate the feasibility, safety, and effectiveness of SAT-003 in patients with cancer cachexia who have been diagnosed with solid tumors and discontinued chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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
结局指标
主要结局
Change in Karnofsky Performance Status(KPS)score
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Chagne in Korean Modified Barthel Index (KBMI) Score
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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).
Change in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Rate of Change (%) in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Change in Lean Body Mass(LBM) and Rate of LBM Change (%)
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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).
Survival Rate (%) at 24 weeks
时间窗: Baseline, 24weeks
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.
Chemotherapy Resumption Rate(%)
时间窗: 12 weeks, 24weeks
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
Change in Karnofsky Performance Status(KPS)score
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Chagne in Korean Modified Barthel Index (KBMI) Score
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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).
Change in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Rate of Change (%) in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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.
Change in Lean Body Mass(LBM) and Rate of LBM Change (%)
时间窗: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
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).
Survival Rate (%) at 24 weeks
时间窗: Baseline, 24weeks
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.
Chemotherapy Resumption Rate(%)
时间窗: 12 weeks, 24weeks
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
Chemotherapy Resumption period(days)
时间窗: 24weeks
The evaluate the duration from application SAT-003 to resumption of chemotherapy.
次要结局
- Change in Number of External Activity Performances(Baseline, Week12, through study completion, an average of 24 weeks)
- Adherence Assessment During the Treatment Period(Baseline, Week12, through study completion, an average of 24 weeks)
- 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)