Trial Information
Changhua Christian Hospital
Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going
chemotherapy or radiotherapy.
Inclusion Criteria:
- Postoperative patients with histologically confirmed cancer within 3 years and
undergoing chemotherapy or radiotherapy
- age above 18 years old
- signed informed consent
- ability to read Chinese, ability for oral intake.
Exclusion Criteria:
- being pregnancy
- on breast feeding
- completed chemotherapy or radiotherapy
- brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of
two to four
- delusion or hallucination
- acute infection
- received medications for other clinical trials.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Change from baseline in EORTC QOL-C30 at four weeks
Outcome Time Frame:
baseline and four weeks
Safety Issue:
No
Principal Investigator
Lun Chien Lo, MD. PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Changhua Christian Hospital
Authority:
Taiwan: Department of Health
Study ID:
CCMP98 -CT-203
NCT ID:
NCT01580358
Start Date:
October 2009
Completion Date:
September 2012
Related Keywords:
- Cancer Patients Undergoing Chemotherapy or Radiotherapy
- cancer
- radiotherapy
- chemotherapy
- Traditional Chinese Medicine
- Safety