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

Not Applicable

Active, not recruiting

• Conditions: Cancer Cachexia
• Interventions: Device: SAT-003

• Registration Number: NCT06476197
• Lead Sponsor: S-Alpha Therapeutics, Inc.

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Primary Completion: 2024-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Study Completion: 2025-04-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAT-003	SAT-003	-

Primary Outcome Measures

Name	Time	Method
Change in EORTC QLQ-C30 score	Baseline, 6weeks, 12weeks, 18weeks, 24weeks	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.
Change in Karnofsky Performance Status	Baseline, 6weeks, 12weeks, 18weeks, 24weeks	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.
Rate of Change (%) in Grip Strength (lbs)	Baseline, 6weeks, 12weeks, 18weeks, 24weeks
Chagne in Korean Modified Barthel Index Score	Baseline, 6weeks, 12weeks, 18weeks, 24weeks	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.
Change in Lean Body Mass and Rate of Change (%)	Baseline, 6weeks, 12weeks, 18weeks, 24weeks	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.
Change in Grip Strength (lbs)	Baseline, 6weeks, 12weeks, 18weeks, 24weeks	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.
Survival Rate (%) at 24 weeks	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(%)	24weeks	The proportion of patients who resumed chemotherapy at 12 and 24 weeks
Chemotherapy Resumption period(days)	24weeks	The evaluate the duration from application SAT-003 to resumption of chemotherapy.

Trial Locations

Locations (1)

Dongkuk University Ilsan Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of