Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Gastrointestinal Agents

Anticoagulants

Cisplatin

Fucoidan

Antacids

Anti-Ulcer Agents

Fucoidan powder at 4.4 g per sachet (dose) for oral administration. Fucoidan 4.4 g, PO, bid for 24 weeks

Potato starch at 4.4 g per sachet (dose) for oral administration. Potato starch 4.4 g, PO, bid for 24 weeks

Fucoidan refers to a class of fucose-enriched sulfated polysaccharides with an average molecular weight of 20,000 Daltons (Da), which can be found in many varieties of edible brown seaweeds and algae . In cell culture studies and animal studies, fucoidan has been shown to possess a range of biological activities, including anti-cancer, anti-inflammatory, and immunoregulatory effects . A recent in vitro study conducted in head and neck squamous cell carcinoma (HNSCC) cell lines (H103, FaDu, and KB) showed that fucoidan could induce cell cycle arrest and possibly apoptosis in a dose-dependent manner, while also enhancing response to cisplatin treatment . In addition, fucoidan has also been shown to inhibit the proliferation of nasopharyngeal carcinoma cells and MC3 human mucoepidermoid carcinoma (MEC) cells .

Placebo( Potato starch)

Christy Lee

Pei-Jen Lou

This phase II study is a randomized, double-blind study that seeks to evaluate the clinical effects and safety of fucoidan in the treatment of cancer patients with stage III/IV head and neck squamous cell carcinoma.

Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period.

Clinical effects and safety parameters for all subjects who complete the treatment period will be followed for an additional 72 weeks after the treatment period.

This phase II study is a randomized, double-blind study that seeks to evaluate the clinical effects and safety of fucoidan in the treatment of cancer patients with stage III/IV head and neck squamous cell carcinoma.

Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period.

Clinical effects and safety parameters for all subjects who complete the treatment period will be followed for an additional 72 weeks after the treatment period.

The total length of the study for each subject will be approximately 100 weeks, comprising the following time periods: screening period (28 days), treatment period (24 weeks), and follow-up period (72 weeks).

Fucoidan Group: Fucoidan 4.4 g, PO, bid for 24 weeks Placebo Group: Potato starch 4.4 g, PO, bid for 24 weeks

Patients will be centrally randomized in a 1:1 ratio to receive either Fucoidan or placebo (potato starch) Eligible subjects will receive fucoidan twice daily (BID) in combination with chemotherapy and radiation therapy over a 24-week treatment period.

A Randomized, Double-blind Study to Evaluate the Clinical Effect and Safety of Fucoidan in Patients With Squamous Cell Carcinomas of the Head and Neck

To evaluate the safety of fucoidan, as defined by the incidence of treatment-emergent adverse events (TEAEs)

To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: EuroQol five dimensions questionnaire (EQ5D)

To evaluate the quality of life (QoL) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by using questionnaire: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 35 (H\&N 35)

To evaluate disease-free survival (DFS) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy

To evaluate pain in patients treated with a combination of fucoidan, chemotherapy, and radiation therapy by a numerical rating scale (NRS: 0-10)

To evaluate the disease control rate (DCR) of patients treated with a combination of fucoidan, chemotherapy, and radiation therapy

Hi-Q Marine Biotech International, Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

Oligo Fucoidan 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment.

Placebo 4.4 g, sachet, oral, twice a day from Study Day -2 to End of Treatment.

Oligo Fucoidan

Placebo

Primary Objectives:

To evaluate the Quality of Life (QoL) score of adding oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects with Non-Small Cell Lung Cancer (NSCLC).

Secondary Objectives:

To assess the progression-free survival (PFS) and objective response rate (ORR) of adding oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects with NSCLC.

This is a pilot, randomized, double-blind, multicenter study to evaluate the QoL score of Oligo Fucoidan plus platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in subjects with NSCLC. Subjects will be randomized in a 1:1 ratio to receive 4.4 g BID of Oligo Fucoidan or placebo BID. Subject randomization will be stratified by NSCLC disease stage (stage III and stage IV) and platinum-based drug (cisplatin and carboplatin).

This is a two-part study. The study treatment will be planned as follow:

1. Part I (Platinum-based Treatment Phase): Oligo Fucoidan/placebo in combination with 4\~6 cycles of platinum-based chemotherapy;
2. Part II (Extension Phase): Continuous Oligo Fucoidan/placebo treatment after subject completed platinum-based chemotherapy.

The total study treatment duration of investigational product from Part I to Part II will be 6 months.

Dosing of oral Oligo Fucoidan/placebo will begin on Study Day -2, 2 days prior to the start of the platinum-based chemotherapy regimen, and will continue twice a day (BID) through the following 6-months treatment period, which includes platinum-based treatment phase and extension phase, if there's no treatment interruption. All subjects will receive platinum-based IV infusion starting on Day 1 of each cycle, 3 weeks per cycle. Subjects will continue to receive Oligo Fucoidan/placebo for 6 months until develop of treatment toxicity which in the Investigator's opinion prohibits for further therapy, or until radiographic progression of disease. Subjects who experience toxicities due to chemotherapy may require a delay in the dosing schedule or a dose modification. Should a subject not receive platinum-based chemotherapy on a scheduled cycle, a rescheduled cycle will be designated when chemotherapy is reintroduced, but no more than 2 weeks delay.

The visit for subjects who have completed platinum-based treatment phase will be considered as the End of Part I Visit (end of platinum-based treatment phase). The visit for subjects who have completed 6-months treatment period (Part I \& Part II) will be considered as the End of Treatment (EOT) Visit. It is preferable that EOT Visit procedures will be conducted for subjects prior to the initiation of another anticancer therapy.

Radiographic tumor assessments will be conducted at screening period, Cycle 4, End of Platinum-based Treatment Phase, and EOT. Radiographic information will be collected according to the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.

Toxicities will be graded at each study visit according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

Quality of life assessment as measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) as well as health-related quality of life questionnaire designed by the National Health Research Institutes (NHRI), NHRI QLQ-TCM, based on traditional Chinese medicine (TCM) perspective. Both of them will be performed at Study Day -2, Day 8 of Cycle 1, Day 1 of Cycle 3 \& Cycle 5, and End of Platinum-based Treatment Phase.

Randomized, double-blind, multicenter study

To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC

A Randomized, Double-blind, Placebo-controlled, Parallel, Pilot Study to Evaluate the Quality of Life Improvement of Oral Oligo Fucoidan as an Adjuvant in Subjects Receiving Platinum-based Chemotherapy With NSCLC

Comparison of the QoL score changes from Study Day -2 to End of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire

Comparison of the QoL score changes from Study Day -2 to C1D8, C3D1, and C5D1 of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire.

Progression-Free Survival will be evaluated according to radiographic progression per RECIST version 1.1 and survival information (death)

Objective Response Rate will be evaluated using measurements according to RECIST version 1.1

Nervous System Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Sarcopenia

Wasting Syndrome

Cachexia

Syndrome

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

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.

fucoidan

Szu-Yuan Wu

Szu-Yuan Wu, MD, PhD.

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.

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 (Clinical Trial) Actual Enrollment : 100 participants Allocation: Randomized Intervention Model: Parallel Assignment, matching sex, age, and performance status

The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia

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

Lean body mass measured by DEXA. Percentage of change day 90, 60-baseline. (%)

Dominant hand grip strength day 90, 60 - percent change from baseline (%)

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 measured by a visual analogue scale ASAS. Percentage of change day 90, 60-baseline (providing a range of scores from 0-100)

% change between day 90, 60 and baseline (%)

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

leg extension - percentage of change day 90, 60 to baseline (%)

change between day 90, 60 and baseline (continuous variable, t-test)

change between day 90, 60 and baseline(continuous variable, t-test)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized, Double-blind Study to Evaluate the Clinical Effect and Safety of Fucoidan in Patients With Squamous Cell Carcinomas of the Head and Neck	NCT04597476	Squamous Cell C...	Fucoidan Placebo( Potato...	20 Years - 75 Years	Hi-Q Marine Biotech International, Ltd.
To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC	NCT03130829	NSCLC Stage IV NSCLC, Stage II...	Oligo Fucoidan Placebo	20 Years -	Hi-Q Marine Biotech International, Ltd.
The Impact of Oligo-Fucoidan in Cancer Cachexia and Sarcopenia	NCT05623852	Cachexia	fucoidan	20 Years - 90 Years	Taipei Medical University WanFang Hospital
To Evaluate the QoL Improvement of Oral Oligo Fucoidan in Subjects Receiving Platinum-based Chemotherapy With NSCLC	NCT03130829	NSCLC Stage IV NSCLC, Stage II...	Oligo Fucoidan Placebo	20 Years -	Hi-Q Marine Biotech International, Ltd.

Spots Global Cancer Trial Database for fucoidan

Every month we try and update this database with for fucoidan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fucoidan

Every month we try and update this database with for fucoidan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fucoidan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.