The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients

NCT ID: NCT04342949

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-09

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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quality of life

To observe the difference of quality of life

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jaw-Yuan Wang, MD, PhD

Vice Superintendent, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaw-Yuan Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsiang-Lin Tsai, Ph.D

Role: CONTACT

+88673121101 ext. 5553

Jaw-Yuan Wang, Ph.D

Role: CONTACT

+88673121101 ext. 5557

Facility Contacts

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Jaw-Yuan Wang, PhD

Role: primary

Hsiang-Lin Tsai, PH.D

Role: backup

References

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Tsai HL, Yeh YS, Chen PJ, Chang YT, Chen YC, Su WC, Chang TK, Huang CW, Wang JY. The Auxiliary Effects of Low-Molecular-Weight Fucoidan in Locally Advanced Rectal Cancer Patients Receiving Neoadjuvant Concurrent Chemoradiotherapy Before Surgery: A Double-Blind, Randomized, Placebo-Controlled Study. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231187153. doi: 10.1177/15347354231187153.

Reference Type DERIVED
PMID: 37822243 (View on PubMed)

Other Identifiers

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KMUHIRB-F(I)-20180113

Identifier Type: -

Identifier Source: org_study_id

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