The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

NCT05623852 | Unknown DMC

• 1 other identifier: IRB109-195-A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Cachexia

Keywords

Cachexia; sarcopenia; fucidan

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Body Weight Change. (kilograms)

  0 day, 60th day, and 90th day Body weight change

Secondary Outcomes (9)

• Lean Mass Measured by Densitometry

  0 day, 60th day, and 90th day

• Muscle Strength as Measured by Grip Strength.

  0 day, 60th day, and 90th day

• Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments

  0 day, 60th day, and 90th day

• Appetite

  0 day, 60th day, and 90th day

• Resting Energy Expenditure

  0 day, 60th day, and 90th day

Study Arms (2)

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.

Dietary Supplement: fucoidan

Arm B, Observational arm

NO INTERVENTION

observation

Interventions

fucoidan 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 A: Fucoidan arm

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead
• Asia University: collaborator

Study Sites (2)

Asia University

Taichung, Please Select, 116, Taiwan

RECRUITING

Szu-Yuan Wu

Taipei, Please Select, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Cachexia; Sarcopenia

Interventions

fucoidan

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Szu-Yuan Wu

  Asia University, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Szu-Yuan Wu

CONTACT

+886910603955; szuyuanwu5399@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: November 21, 2022
• Study Start: January 30, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: November 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will become available on April 30 2022.
• Access Criteria: requirement with official application

Locations

TW (2)