The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia (OFCS)

Taipei Medical University

Status: Enrolling

Conditions: Cachexia

Treatments: Dietary Supplement: fucoidan

Study type: Interventional

Funder types: Other

Identifiers

NCT05623852

IRB109-195-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm A: Fucoidan arm

Experimental group

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.

Treatment:

Dietary Supplement: fucoidan

Arm B, Observational arm

No Intervention group

Description:

observation