Patients with gastrointestinal (colon or gastric) cancer or NSCLC undergoing chemotherapy (treatment of cancer-related cachexia)
Conditions
Interventions
Product Name: BST204 capsule 100 mg
Product Code: BST204
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BST 204
Current Sponsor code: BST204
Other descriptive name: Refined Ginseng Extract
Co
Sponsors
GREEN CROSS WellBeing
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Signed informed consent •Ability to understand and follow the requirements of the trial •Diagnosis of advanced GI or NSCLC receiving palliative chemotherapy with a 5-FU or platinum-based regimen, respectively. Or diagnosis of NSCLC receiving intravenous immunotherapy as first-line therapy. •Life expectancy of >6 months at time of screening •Involuntary weight loss of =5% body weight within 6 months prior to screening, or of =2% with BMI =65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: The following exclusion criteria will be applied for patients with advanced GI cancer or NSCLC: •Contraindications to ginseng: allergy or hypersensitivity to Panax sp. or their constituents •Ginseng, megestrol, thalidomide, androgenic • steroids (e.g., testosterone, oxandrolone), dronabinol (tetrahydrocannabinoid) or any prescription drug intended to increase appetite or treat weight loss taken within the previous 10 days (or 3 month if extended release) before the first treatment with BST204 (corticosteroids at the time of chemotherapy are allowed) • Tube feeding, parenteral nutrition • Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study • Uncontrolled diabetes mellitus • Ascites or edema, BMI> 30 kg/m2 • Diagnosis of symptomatic tachycardia, arrhythmia, severe angina pectoris, uncontrolled hypertension or heart failure •Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) •Heart rate below 45 or above 100 bpm • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) >5 × upper limit of normal (ULN) • Total bilirubin >2x ULN • Calculated creatinine clearance <30 mL • Uncontrolled pain, hypothyroidism • Major surgery within 4 weeks before randomization visit or planned surgery during the study period • Pregnant or nursing women • Women of childbearing potential not using adequate contraception. Adequate contraception is defined as methods that can achieve a failure rate of less than 1% when used consistently and correctly, such as — combined (estrogen and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) — progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) — intrauterine device, intrauterine hormone-releasing system — bilateral tubal occlusion — vasectomized partner (vasectomy at least 3 months prior to screening) — sexual abstinence • Pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to explore the efficacy of BST204 in cancer-related cachexia ;Secondary Objective: Secondary objective is to assess safety and tolerability of BST204 in patients with cancer-related cachexia ;Primary end point(s): •Physical function: stair climb power changes to baseline after 12 weeks of treatment;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Physical function: stair climb power changes to baseline after 4 and 8 weeks of treatment •Lean Body Mass (LBM; bioelectrical impedance analysis [BIA], Dual-energy X-ray absorptiometry [DXA] Note: DXA only after authorization by German national authority): BIA: changes to baseline after 4, 8, and 12 weeks of treatment DXA: changes to baseline after 12 weeks of treatment •Physical function: 6-minute walking test, grip strength after 4, 8, and 12 weeks of treatment •Quality of Life (QoL): changes to baseline in appetite after 4, 8, and 12 weeks of treatment in questionnaire scores (Functional Assessment of Anorexia/Cachexia [FAACT] questionnaire) •Fatigue: changes to baseline after 4, 8, and 12 weeks of treatment in questionnaire scores (Functional Assessment of Chronic Illness Therapy [FACIT] questionnaire) •Adverse events (AEs) ;Timepoint(s) of evaluation of this end point: after 4, 8, and 12 weeks of treatment | — |
Countries
Georgia, Germany, Ukraine
Contacts
Public ContactProject Management
PSI CRO AG
Outcome results
None listed