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

Sponsor

Taipei Medical University WanFang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05623852

Collaborator

Asia University (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cachexia	Dietary Supplement: fucoidan	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial for Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

Actual Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: 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.
No Intervention: Arm B, Observational arm observation

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: fucoidan

No Intervention: Arm B, Observational arm

observation

Outcome Measures

Primary Outcome Measures

Body Weight [0 day, 60th day, and 90th day Body weight change]
Body Weight Change. (kilograms)

Secondary Outcome Measures

Lean Mass Measured by Densitometry [0 day, 60th day, and 90th day]
Lean body mass measured by DEXA. Percentage of change day 90, 60-baseline. (%)
Muscle Strength as Measured by Grip Strength. [0 day, 60th day, and 90th day]
Dominant hand grip strength day 90, 60 - percent change from baseline (%)
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments [0 day, 60th day, and 90th day]
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)
Appetite [0 day, 60th day, and 90th day]
Appetite measured by a visual analogue scale ASAS. Percentage of change day 90, 60-baseline (providing a range of scores from 0-100)
Resting Energy Expenditure [0 day, 60th day, and 90th day]
% change between day 90, 60 and baseline (%)
Functional Performance [0 day, 60th day, and 90th day]
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
1-repetition Max. Strength [0 day, 60th day, and 90th day]
leg extension - percentage of change day 90, 60 to baseline (%)
Food Diary Calorie Count [0 day, 60th day, and 90th day]
change between day 90, 60 and baseline (continuous variable, t-test)
Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3. [0 day, 60th day, and 90th day]
change between day 90, 60 and baseline(continuous variable, t-test)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.