The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients
- Conditions
- To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT
- Registration Number
- NCT04342949
- Brief Summary
This is a double-blind, randomized, placebo-controlled, parallel study. The main goal is to investigate the auxiliary effects of Fucoidan for the patients with locally advanced rectal cancer who receive neoadjuvant CCRT before surgery. The quality of life is our primary endpoint for this study. The study is an observational study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Age was more/equal to 20 year-old and less/equal to 80 year-old
- Diagnosed as locally advanced rectal cancers by pathological biopsy and image study.
- ECOG performance status within 0 to 2 points
- Excepted life remaining at least 4 months
- Females with fertility are willing to use effective contraception during the period of study
- Willing to follow the test procedures and tracking procedures
- sign the inform consent form
1.Suffering from other primary malignant tumors 2.Females who are pregnant, planning to become pregnant, or breastfeeding 3.Participate in other interventional clinical trial within the first 30 days 4.Suffering from major mental illness such as mental retardation and mental disorders 5.Unable to understand and answer research questions (oral or written) 6.Abnormal laboratory data within 14 days before joining the study 7.Evidence that subject has a severe or uncontrolled disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method auxiliary effects of Fucoidan 2 years To evaluate the quality of life after unblind by 4th edit of FACT-C
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
🇨🇳Kaohsiung, Taiwan