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Trial Title:
The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
NCT ID:
NCT05623852
Condition:
Cachexia
Conditions: Official terms:
Sarcopenia
Wasting Syndrome
Cachexia
Fucoidan
Conditions: Keywords:
Cachexia
sarcopenia
fucidan
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants
Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and
performance status
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
fucoidan
Description:
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.
Arm group label:
Arm A: Fucoidan arm
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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 .
2. Chemotherapy regimen include platinum-based drugs and Gemcitabine based drugs;
3. 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;
4. Patients are conscious and able to cooperate with the doctor to complete the
disease-related examinations and evaluations;
5. 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;
6. Expected survival period is more than 3 months;
7. Male or female aged 20 - 90 years;
8. Patients who are willing to participate in the study and sign the informed consent
form.
Exclusion Criteria:
1. Patients who are being treated with chemotherapy, the chemotherapy regimen is not
among the regimens specified in the protocol;
2. 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.;
3. 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.;
4. Known or suspected diagnosis of metastatic encephaloma;
5. Patients present with an ECOG score>2 and require treatment of chemotherapy;
6. Patients who are currently included in other clinical trials on antineoplastic
drugs;
7. Patients who are not able to provide the Informed Consent Form (ICF);
8. Expected survival period is less than 4 months;
9. Female patient is pregnant or breast-feeding, and those patients at childbearing age
who are not willing to use methods of contraception (including males);
10. Patients with symptomatic, uncontrolled nervous disorders, mental illness or
psychiatric disorder;
11. 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Asia University
Address:
City:
Taichung
Zip:
116
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Szu-Yuan Wu, MD, PhD.
Phone:
0910603955
Email:
szuyuanwu5399@gmail.com
Facility:
Name:
Szu-Yuan Wu
Address:
City:
Taipei
Zip:
116
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Szu-Yuan Wu
Phone:
0910603955
Email:
szuyuanwu5399@gmail.com
Start date:
January 30, 2022
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Taipei Medical University WanFang Hospital
Agency class:
Other
Collaborator:
Agency:
Asia University
Agency class:
Other
Source:
Taipei Medical University WanFang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05623852
