The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

NCT ID: NCT05623852

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2025-04-30

Brief 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.

Conditions

Cachexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Fucoidan arm

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.

Group Type: EXPERIMENTAL

fucoidan

Intervention Type: DIETARY_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.

Arm B, Observational arm

observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fucoidan

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asia University

OTHER

Sponsor Role: collaborator

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Szu-Yuan Wu

Role: PRINCIPAL_INVESTIGATOR

Asia University, Taiwan

Locations

Asia University

Taichung, Please Select, Taiwan

Site Status: RECRUITING

Szu-Yuan Wu

Taipei, Please Select, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Szu-Yuan Wu

Role: CONTACT

szuyuanwu5399@gmail.com

+886910603955

Facility Contacts

Szu-Yuan Wu, MD, PhD.

Role: primary

szuyuanwu5399@gmail.com

0910603955

Szu-Yuan Wu

Role: primary

szuyuanwu5399@gmail.com

0910603955

Other Identifiers

IRB109-195-A

Identifier Type: -

Identifier Source: org_study_id