Clinical trial NCT05623852: The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
Official title: A Phase II Trial for Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cachexia
Keywords: Cachexia
sarcopenia
fucidan
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Asia University
First posted: 2022-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Type : Interventional (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Weight
timeFrame: 0 day, 60th day, and 90th day Body weight change
Secondary outcomes:
measure: Lean Mass Measured by Densitometry
timeFrame: 0 day, 60th day, and 90th day
measure: Muscle Strength as Measured by Grip Strength.
timeFrame: 0 day, 60th day, and 90th day
measure: Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments
timeFrame: 0 day, 60th day, and 90th day
measure: Appetite
timeFrame: 0 day, 60th day, and 90th day
measure: Resting Energy Expenditure
timeFrame: 0 day, 60th day, and 90th day
measure: Functional Performance
timeFrame: 0 day, 60th day, and 90th day
measure: 1-repetition Max. Strength
timeFrame: 0 day, 60th day, and 90th day
measure: Food Diary Calorie Count
timeFrame: 0 day, 60th day, and 90th day
measure: Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3.
timeFrame: 0 day, 60th day, and 90th day
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University
state: Please Select
city: Taipei
country: Taiwan
facility: Szu-Yuan Wu
state: Please Select
Study officials:
affiliation: Asia University, Taiwan
name: Szu-Yuan Wu
role: PRINCIPAL_INVESTIGATOR
References: