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

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

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 Overview

• Status: Recruiting
• Conditions: Cachexia
• Intervention / Treatment: Dietary supplement: fucoidan

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Szu-Yuan Wu; Phone Number: +886910603955; Email: szuyuanwu5399@gmail.com

Study Locations

• Taiwan
  • Please Select
    • Taichung, Please Select, Taiwan, 116
      • Recruiting
      • Asia University
    • Taipei, Please Select, Taiwan, 116
      • Recruiting
      • Szu-Yuan Wu
      • Contact: Szu-Yuan Wu; Phone Number: 0910603955; Email: szuyuanwu5399@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Body Weight Change. (kilograms)	0 day, 60th day, and 90th day Body weight change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Resting Energy Expenditure	% change between day 90, 60 and baseline (%)	0 day, 60th day, and 90th day
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
1-repetition Max. Strength	leg extension - percentage of change day 90, 60 to baseline (%)	0 day, 60th day, and 90th day
Food Diary Calorie Count	change between day 90, 60 and baseline (continuous variable, t-test)	0 day, 60th day, and 90th day
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Collaborators: Asia University
• Investigators: Principal Investigator: Szu-Yuan Wu, Asia University, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: sarcopenia; Cachexia; fucidan
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Muscular Atrophy; Atrophy; Emaciation; Weight Loss; Sarcopenia; Wasting Syndrome; Cachexia; Antineoplastic Agents; Gastrointestinal Agents; Anticoagulants; Anti-Ulcer Agents; Fucoidan
• Other Study ID Numbers: IRB109-195-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: study completed
• IPD Sharing Time Frame: data will become available on April 30 2022.
• IPD Sharing Access Criteria: requirement with official application
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No