NCT04342949UnknownNot Applicable
A Double-blind, Randomized, Placebo-controlled, Parallel Study to Investigate the Auxiliary Effects of Fucoidan in Patients With Locally Advanced Rectal Cancer Who Receive Combined Radio-chemotherapy Before Surgery
Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country100 target enrollmentStarted: November 9, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- auxiliary effects of Fucoidan
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
auxiliary effects of Fucoidan
Time Frame: 2 years
To evaluate the quality of life after unblind by 4th edit of FACT-C
Secondary Outcomes
No secondary outcomes reported
Investigators
Jaw-Yuan Wang, MD, PhD
Vice Superintendent, Professor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Sites (1)
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