The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cachexia

Intervention / Treatment
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* Dietary Supplement: fucoidan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Fucoidan arm<br>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<br>* 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.<br>|
| No Intervention: Arm B, Observational arm<br>observation | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cachexia, sarcopenia, fucidan