Advanced Cancer
Conditions
Keywords
no available effective treatment
Brief summary
The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.
Interventions
DRUGchlorogenic acid
Sponsors
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* advanced cancer with no effective treatment * Karnofsky performance status no less than 70 * adequated organ function * informed consent
Exclusion criteria
* allergic to chlorogenic acid * persistent toxicities from previous treatment (no less than grade 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | within the first 60 days after the first dose of chlorogenic acid |
Secondary
| Measure | Time frame |
|---|---|
| improvement in cancer-related symptoms and quality of life | within 1 year after the first dose of chlorogenic acid |
| Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid | within the first 30 days after the first dose of chlorogenic acid |
| dose-limiting toxicity | within the first 30 days after the first dose of chlorogenic acid |
| maximum tolerated dose | within the first 30 days after the first dose of chlorogenic acid |
Other
| Measure | Time frame |
|---|---|
| change in levels of tumor markers | within 1 year after the first dose of chlorogenic acid |
| change in the diameters of lymph node metastasis | within 1 year after the first dose of chlorogenic acid |
| Change in number of red blood cell and level of hemoglobin | within 1 year after the first dose of chlorogenic acid |
Outcome results
None listed