The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients

April 9, 2020 updated by: Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Chung-Ho Memorial Hospital, Kaohsiung Medical University:
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaw-Yuan Wang, Ph.D.
        • Sub-Investigator:
          • Hsiang-Lin Tsai, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

we enrolled the patients with locally advanced rectal cancers and received neoadjuvant CCRT (concurrent radiochemotherapy) before.

Description

Inclusion Criteria:

  1. Age was more/equal to 20 year-old and less/equal to 80 year-old
  2. Diagnosed as locally advanced rectal cancers by pathological biopsy and image study.
  3. ECOG performance status within 0 to 2 points
  4. Excepted life remaining at least 4 months
  5. Females with fertility are willing to use effective contraception during the period of study
  6. Willing to follow the test procedures and tracking procedures
  7. 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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
auxiliary effects of Fucoidan
Time Frame: 2 years
To evaluate the quality of life after unblind by 4th edit of FACT-C
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Jaw-Yuan Wang, Ph.D, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KMUHIRB-F(I)-20180113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT

Clinical Trials on quality of life

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe