CompletedNot Applicable

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

South Korea15 participantsStarted 2023-07-11

Plain-language 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.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.)

Exclusion criteria

✕. 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

What they're measuring

Change in Karnofsky Performance Status(KPS)score

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

Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score

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

Chagne in Korean Modified Barthel Index (KBMI) Score

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

Change in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)

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

Rate of Change (%) in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)

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

Change in Lean Body Mass(LBM) and Rate of LBM Change (%)

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

Survival Rate (%) at 24 weeks

Timeframe: Baseline, 24weeks

Trial details

NCT IDNCT06476197

SponsorS-Alpha Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Cancer Cachexia trials

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.)

Exclusion criteria

✕. 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

What they're measuring

Change in Karnofsky Performance Status(KPS)score

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

Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score

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

Chagne in Korean Modified Barthel Index (KBMI) Score

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

Change in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)

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

Rate of Change (%) in Grip Strength(Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) (lbs)

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

Change in Lean Body Mass(LBM) and Rate of LBM Change (%)

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

Survival Rate (%) at 24 weeks

Timeframe: Baseline, 24weeks