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Trial Title:
Exploratory Clinical Trial to Safety and Efficacy of SAT-003 in Cancer Cachexia Patients Discontinued Chemotherapy Who Had Diagnosed With Solid Cancer
NCT ID:
NCT06476197
Condition:
Cancer Cachexia
Conditions: Official terms:
Wasting Syndrome
Cachexia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
SAT-003
Description:
Device: SAT-003(Software) Using SAT-003 for 12 weeks
Arm group label:
SAT-003
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongkuk University Ilsan Hospital
Address:
City:
Gyeonggi-do
Country:
Korea, Republic of
Start date:
June 15, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
S-Alpha Therapeutics, Inc.
Agency class:
Industry
Source:
S-Alpha Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06476197
