The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

Cachexia Clinical Trial

— OFCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623852
• Other study ID #: IRB109-195-A
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2022
• Source: Taipei Medical University WanFang Hospital
• Contact: Szu-Yuan Wu
• Phone: +886910603955
• Email: szuyuanwu5399[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Asia University	Taichung	Please Select
Taiwan	Szu-Yuan Wu	Taipei	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital	Asia University

Country where clinical trial is conducted

Taiwan, 

Outcome

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