Clinical trial NCT06476197: Exploratory Trial of SAT-003 in Cancer Cachexia Patients With Discontinued Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Cachexia
Lead sponsor: S-Alpha Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Karnofsky Performance Status
timeFrame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
measure: Change in EORTC QLQ-C30 score
timeFrame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
measure: Chagne in Korean Modified Barthel Index Score
timeFrame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
measure: Change in Grip Strength (lbs)
timeFrame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
measure: Rate of Change (%) in Grip Strength (lbs)
timeFrame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
measure: Change in Lean Body Mass and Rate of Change (%)
timeFrame: Baseline, 6weeks, 12weeks, 18weeks, 24weeks
measure: Survival Rate (%) at 24 weeks
timeFrame: Baseline, 24weeks
measure: Chemotherapy Resumption Rate(%)
timeFrame: 24weeks
measure: Chemotherapy Resumption period(days)
timeFrame: 24weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Dongkuk University Ilsan Hospital
Study officials:
References: