To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRTNCT04342949
The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients
An observational study of To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT
- What is being tested?
- quality of life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: we enrolled the patients with locally advanced rectal cancers and received neoadjuvant CCRT (concurrent radiochemotherapy) before.
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, 807
Jaw-Yuan Wang, PhD, cy614112@ms14.hinet.net
Hsiang-Lin Tsai, PH.D, chunpin870132@yshaoo.com.tw
About this study
Official title: 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.
- Being tested
- quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeBehavioural
To observe the difference of quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
auxiliary effects of Fucoidan
To evaluate the quality of life after unblind by 4th edit of FACT-C
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start9 Nov 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRTStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jaw-Yuan Wang, Ph.D, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342949
- Sponsor's protocol ID
- KMUHIRB-F(I)-20180113
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37822243
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04342949
- Acronym / sponsor ID
- KMUHIRB-F(I)-20180113
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- we enrolled the patients with locally advanced rectal cancers and received neoadjuvant CCRT (concurrent radiochemotherapy) before.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of lifeTo observe the difference of quality of life | Behavioural | – |
Primary outcome
auxiliary effects of Fucoidan
Time frame: 2 years
To evaluate the quality of life after unblind by 4th edit of FACT-C
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Derived from this study: PubMed 37822243Tsai 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaw-Yuan Wang, Ph.D principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiang-Lin Tsai, Ph.D (+88673121101 ext. 5553, chunpin870132@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
auxiliary effects of Fucoidan (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.