AzTrials
AzTrials

Cancer CachexiaNCT06476197

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

A study testing SAT-003 in people with Cancer Cachexia, run by S-Alpha Therapeutics, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Cancer Cachexia
What is being tested?
SAT-003
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Korea
Study dates
11 Jul 2023to 3 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Dongguk University Ilsan Hospital

    Ilsan, Gyeonggi-do, 10326

Other trials in South Korea

About this study

Official title: 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

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.

Read the 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.

Conditions
Cancer Cachexia
Being tested
SAT-003

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAT-003Device

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

Study groups in NCT06476197
Study groupRoleWhat they receive
SAT-003 Treatment arm(Single arm)ExperimentalArm 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.
Receives: Device: SAT-003

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6weeks, 12weeks, 18weeks, 24weeks

  2. 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.

    Measured: Baseline, 6weeks, 12weeks, 18weeks, 24weeks

  3. 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).

    Measured: Baseline, 6weeks, 12weeks, 18weeks, 24weeks

  4. 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.

    Measured: Baseline, 6weeks, 12weeks, 18weeks, 24weeks

  5. 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.

    Measured: Baseline, 6weeks, 12weeks, 18weeks, 24weeks

  6. 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).

    Measured: Baseline, 6weeks, 12weeks, 18weeks, 24weeks

  7. 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.

    Measured: Baseline, 24weeks

  8. 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

    Measured: 12 weeks, 24weeks

  9. Chemotherapy Resumption period(days)

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

    Measured: 24weeks

Secondary outcomes (2)
  1. Adherence Assessment During the Treatment Period

    Adherence to device use, measured by the number of sessions performed within the specified period, is evaluated weekly from Baseline (Visit 2) to Week 12 (Visit 8) post-treatment.

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

  2. Change in Number of External Activity Performances

    The change in external activity performance, measured weekly using the investigational medical device, is evaluated from Baseline (Visit 2) to Week 12 (Visit 8) post-treatment. The change in external activity is calculated by comparing the initial number of activity performances within a session to the last data point of the session week.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start11 Jul 2023
  3. Primary completion30 Aug 2024
  4. Study completion3 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476197
Sponsor's protocol ID
SAT003-KP-001
Status last verified
Jun 2025
First submitted
27 May 2024
Last updated
17 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SAT-003 in people with Cancer Cachexia, run by S-Alpha Therapeutics, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Karnofsky Performance Status(KPS)score (time frame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in