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

Primary Purpose

Cachexia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
fucoidan
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia focused on measuring Cachexia, sarcopenia, fucidan

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Asia UniversityRecruiting
  • Szu-Yuan WuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A: Fucoidan arm

Arm B, Observational arm

Arm Description

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.

observation

Outcomes

Primary Outcome Measures

Body Weight
Body Weight Change. (kilograms)

Secondary Outcome Measures

Lean Mass Measured by Densitometry
Lean body mass measured by DEXA. Percentage of change day 90, 60-baseline. (%)
Muscle Strength as Measured by Grip Strength.
Dominant hand grip strength day 90, 60 - percent change from baseline (%)
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)
Appetite
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
% change between day 90, 60 and baseline (%)
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
1-repetition Max. Strength
leg extension - percentage of change day 90, 60 to baseline (%)
Food Diary Calorie Count
change between day 90, 60 and baseline (continuous variable, t-test)
Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3.
change between day 90, 60 and baseline(continuous variable, t-test)

Full Information

First Posted
April 7, 2022
Last Updated
November 13, 2022
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Asia University
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1. Study Identification

Unique Protocol Identification Number
NCT05623852
Brief Title
The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
Acronym
OFCS
Official Title
A Phase II Trial for Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Asia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia
Keywords
Cachexia, sarcopenia, fucidan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Fucoidan arm
Arm Type
Experimental
Arm Description
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 Title
Arm B, Observational arm
Arm Type
No Intervention
Arm Description
observation
Intervention Type
Dietary Supplement
Intervention Name(s)
fucoidan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight
Description
Body Weight Change. (kilograms)
Time Frame
0 day, 60th day, and 90th day Body weight change
Secondary Outcome Measure Information:
Title
Lean Mass Measured by Densitometry
Description
Lean body mass measured by DEXA. Percentage of change day 90, 60-baseline. (%)
Time Frame
0 day, 60th day, and 90th day
Title
Muscle Strength as Measured by Grip Strength.
Description
Dominant hand grip strength day 90, 60 - percent change from baseline (%)
Time Frame
0 day, 60th day, and 90th day
Title
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments
Description
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)
Time Frame
0 day, 60th day, and 90th day
Title
Appetite
Description
Appetite measured by a visual analogue scale ASAS. Percentage of change day 90, 60-baseline (providing a range of scores from 0-100)
Time Frame
0 day, 60th day, and 90th day
Title
Resting Energy Expenditure
Description
% change between day 90, 60 and baseline (%)
Time Frame
0 day, 60th day, and 90th day
Title
Functional Performance
Description
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
Time Frame
0 day, 60th day, and 90th day
Title
1-repetition Max. Strength
Description
leg extension - percentage of change day 90, 60 to baseline (%)
Time Frame
0 day, 60th day, and 90th day
Title
Food Diary Calorie Count
Description
change between day 90, 60 and baseline (continuous variable, t-test)
Time Frame
0 day, 60th day, and 90th day
Title
Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3.
Description
change between day 90, 60 and baseline(continuous variable, t-test)
Time Frame
0 day, 60th day, and 90th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Szu-Yuan Wu
Phone
+886910603955
Email
szuyuanwu5399@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szu-Yuan Wu
Organizational Affiliation
Asia University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asia University
City
Taichung
State/Province
Please Select
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szu-Yuan Wu, MD, PhD.
Phone
0910603955
Email
szuyuanwu5399@gmail.com
Facility Name
Szu-Yuan Wu
City
Taipei
State/Province
Please Select
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szu-Yuan Wu
Phone
0910603955
Email
szuyuanwu5399@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study completed
IPD Sharing Time Frame
data will become available on April 30 2022.
IPD Sharing Access Criteria
requirement with official application

Learn more about this trial

The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

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