Cachexia
Conditions
Keywords
Cachexia, sarcopenia, fucidan
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.
Interventions
DIETARY_SUPPLEMENTfucoidan
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.
Sponsors
Asia University
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 0 day, 60th day, and 90th day Body weight change | Body Weight Change. (kilograms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| 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. (%) |
| 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) |
| 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 |
Countries
Taiwan
Contacts
Primary ContactSzu-Yuan Wu
Outcome results
None listed