cancer-related muscle wasting

Phase 1

• Conditions: Patients with gastrointestinal (colon or gastric) cancer or NSCLC undergoing chemotherapy (treatment of cancer-related cachexia); Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-003271-61-DE
• Lead Sponsor: GREEN CROSS WellBeing

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-12
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

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 <20 kg/m2
•Eastern Cooperative Oncology Group (ECOG) performance status =2
•Age between 18 and 80 years (inclusive)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified