CachexiaOFCSNCT05623852
The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
A study testing fucoidan in people with Cachexia, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
Trial summary
Fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Cachexia
- What is being tested?
- fucoidan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 30 Jan 2022to 30 Apr 2025
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed patients with stage III-IV non-small cell lung cancer, colorectal carcinoma, head and neck cancer, nasopharyngeal cancer, or pancreatic carcinoma, who are not eligible for surgery, and interventional treatment .
- Chemotherapy regimen include platinum-based drugs and Gemcitabine based drugs;
- For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period;
- Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
- ECOG performance status (PS) 0-3 for those who are not treated with chemotherapy; and ECOG PS 0-2 for those who are being treated with chemotherapy;
- Expected survival period is more than 3 months;
- Male or female aged 20 - 90 years;
- Patients who are willing to participate in the study and sign the informed consent form.
Who cannot join
- Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
- Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
- Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
- Known or suspected diagnosis of metastatic encephaloma;
- Patients present with an ECOG score>2 and require treatment of chemotherapy;
- Patients who are currently included in other clinical trials on antineoplastic drugs;
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- Patients who are not able to provide the Informed Consent Form (ICF);
- Expected survival period is less than 4 months;
- Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception (including males);
- Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder;
- Any condition, in the investigator's opinion, is not in the best interest of the subject (e.g., harming the subject's health) or potentially interferes with the evaluation of treatment according to this protocol.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Asia University
Taichung, Please Select, 116
Szu-Yuan Wu, MD, PhD., 0910603955, szuyuanwu5399@gmail.com
- Recruiting
Szu-Yuan Wu
Taipei, Please Select, 116
Szu-Yuan Wu, 0910603955, szuyuanwu5399@gmail.com
About this study
Official title: A Phase II Trial for Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
Fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients.
Read the detailed description
Cancer cachexia is characterized by anorexia, skeletal muscle atrophy, and systemic inflammation. Fucoidan extracted from brown algae exhibits anti-inflammatory and anticancer activities. In addition, fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients.
- Conditions
- Cachexia
- Being tested
- fucoidan
- Keywords
- Cachexia, sarcopenia, fucidan
- Medical subject headings
- Cachexia, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fucoidanDietary supplement
It is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Fucoidan arm | Experimental | It is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food. Receives: Dietary Supplement: fucoidan |
| Arm B, Observational arm | No intervention | observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body Weight Change. (kilograms)
Measured: 0 day, 60th day, and 90th day Body weight change
Secondary outcomes (9)
Lean Mass Measured by Densitometry
Lean body mass measured by DEXA. Percentage of change day 90, 60-baseline. (%)
Measured: 0 day, 60th day, and 90th day
Muscle Strength as Measured by Grip Strength.
Dominant hand grip strength day 90, 60 - percent change from baseline (%)
Measured: 0 day, 60th day, and 90th day
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 90, 60-baseline (with a range from 0 to 52)
Measured: 0 day, 60th day, and 90th day
Appetite
Appetite measured by a visual analogue scale ASAS. Percentage of change day 90, 60-baseline (providing a range of scores from 0-100)
Measured: 0 day, 60th day, and 90th day
Resting Energy Expenditure
% change between day 90, 60 and baseline (%)
Measured: 0 day, 60th day, and 90th day
Functional Performance
Functional performance using stair-climbing power day 90, 60 percent change from baseline (continuous variable ) Power = Work/time Power = (acceleration due to gravity) x mass x distance/time
Measured: 0 day, 60th day, and 90th day
1-repetition Max. Strength
leg extension - percentage of change day 90, 60 to baseline (%)
Measured: 0 day, 60th day, and 90th day
Food Diary Calorie Count
change between day 90, 60 and baseline (continuous variable, t-test)
Measured: 0 day, 60th day, and 90th day
Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3.
change between day 90, 60 and baseline(continuous variable, t-test)
Measured: 0 day, 60th day, and 90th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start30 Jan 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asia University
- Responsible party
- Sponsor
- Investigators
- Szu-Yuan Wu, Principal investigator, Asia University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623852
- Sponsor's protocol ID
- IRB109-195-A
- Acronym
- OFCS
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study completed
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial for Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
- ClinicalTrials.gov ID
- NCT05623852
- Acronym / sponsor ID
- OFCS / IRB109-195-A
- Conditions
- Cachexia
- Keywords
- Cachexia, sarcopenia, fucidan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Collaborators
- Asia University
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Nov 2022 (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.
Fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients.
Detailed description
Cancer cachexia is characterized by anorexia, skeletal muscle atrophy, and systemic inflammation. Fucoidan extracted from brown algae exhibits anti-inflammatory and anticancer activities. In addition, fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
| Arm | Type | Receives |
|---|---|---|
| Arm A: Fucoidan arm | Experimental | Dietary Supplement: fucoidanIt is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food. |
| Arm B, Observational arm | No intervention | –observation |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed patients with stage III-IV non-small cell lung cancer, colorectal carcinoma, head and neck cancer, nasopharyngeal cancer, or pancreatic carcinoma, who are not eligible for surgery, and interventional treatment .
- Chemotherapy regimen include platinum-based drugs and Gemcitabine based drugs;
- For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period;
- Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
- ECOG performance status (PS) 0-3 for those who are not treated with chemotherapy; and ECOG PS 0-2 for those who are being treated with chemotherapy;
Key exclusion criteria (11 listed)
- Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
- Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
- Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
- Known or suspected diagnosis of metastatic encephaloma;
- Patients present with an ECOG score>2 and require treatment of chemotherapy;
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 |
|---|---|---|
| fucoidanIt is recommended to consume on an empty stomach, 2 servings per day, a total of 8 tablets, which can be eaten at one time or in divided doses. If it is difficult to swallow, the powder in the capsule can also be taken out and mixed with food or liquid food. | Dietary supplement | Arm A: Fucoidan arm |
Primary outcome
Body Weight
Time frame: 0 day, 60th day, and 90th day Body weight change
Body Weight Change. (kilograms)
9 secondary outcomes
Lean Mass Measured by Densitometry
Time frame: 0 day, 60th day, and 90th day
Muscle Strength as Measured by Grip Strength.
Time frame: 0 day, 60th day, and 90th day
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments
Time frame: 0 day, 60th day, and 90th day
Appetite
Time frame: 0 day, 60th day, and 90th day
Resting Energy Expenditure
Time frame: 0 day, 60th day, and 90th day
Functional Performance
Time frame: 0 day, 60th day, and 90th day
1-repetition Max. Strength
Time frame: 0 day, 60th day, and 90th day
Food Diary Calorie Count
Time frame: 0 day, 60th day, and 90th day
Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3.
Time frame: 0 day, 60th day, and 90th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Yes. study completed
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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.
Szu-Yuan Wu principal investigator
Asia University, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fucoidan in people with Cachexia, run by Taipei Medical University WanFang Hospital at 2 sites 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 8 inclusion and 11 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Szu-Yuan Wu (+886910603955, szuyuanwu5399@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 0 day, 60th day, and 90th day Body weight change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2022.