Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

5 g/d placebo (maltodextrin)in 10 500-mg capsules for 1 month

Seaweed (Undaria pinnatifida) given orally in ten 500-mg capsules for 1 month

5 g/d placebo in 10 500-mg capsules for one month

Ten 500-mg capsules to be taken orally each day for 1 month

Seaweed

Placebo

Placebo2

Jane Teas, Ph.D.

Could daily consumption of seaweed help explain lower postmenopausal breast cancer (BC) incidence and mortality rates in Japan? This small proof of principle clinical trial was designed to test the idea that the same amount of seaweed normally eaten in Japan would induce metabolic changes when given to non-seaweed consuming healthy postmenopausal American women. The participants were given 10 capsules a day (about 1 tablespoon) for 3 months. During the first month the capsules contained placebo, the second month seaweed, and the third month placebo. We collected blood and urine samples after each treatment period and tested for changes in protein expression that might be related to consuming seaweed.

The relationship between the relative breast cancer (BC) risk and seaweed intake among humans is only now unfolding. A small body of research, both in vivo and in vitro, suggests seaweed may be useful in BC prevention (Funahashi et al. 1999; Teas et al. 1984; Yamamoto et al. 1987) . Seaweeds are specifically used to treat tumors in Traditional Chinese Medicine and Japanese folk medicine. On a population level, those people for whom seaweed is a regular part of their diet, most notably in Japan, have dramatically lower rates of BC (Hebert et al. 1998; Hebert and Rosen 1996; Kodama et al. 1991).

Epidemiologic studies done in Japan in the 1980s, before Westernized diets were common, reported that Japanese women had 1/3 the rate of premenopausal BC and 1/9 the rate of postmenopausal BC (Ferlay et al. 2001; Reddy et al. 1980). Even today, BC incidence rates for women in Japan are 20/100,000 compared to the U.S. average of 118/100,000 (Statistics 2007) . Although genetic predisposition has been proposed, when rates among migrants from Japan to the US are compared, BC incidence almost doubles after 10 years of residence in the US (20/100,000 to 35/100,000) (Shimizu et al. 1991), increase with each successive generation (LeMarchand et al. 1985). Japanese-American women who develop BC have significantly better survival rates than other American ethnic groups (Kanemori and Prygrocki 2005; Pineda et al. 2001). On the other hand, Asian-American women over 50 years of age living in Los Angeles, especially Japanese-American women, have one of the most rapidly increasing BC incidence rates (Deapen et al. 2002). These data support the hypothesis that lifestyle changes and possibly gene-nutrient interactions are important in BC susceptibility.

Seaweed is a typical part of East-Asian diets, although consumption varies widely among individuals (Fukuda et al. 2007). Seaweeds have no land equivalents in terms of their specific components of fiber (alginate), primary carotenoid (fucoxanthin), sulfated polysaccharide (fucoidan and laminarin), and polyphenol defense compounds, each of which has been reported to have strong anti-cancer activity (Kotake-Nara et al. 2005; Koyanagi et al. 2003; Miao et al. 1999; Son et al. 2003).

Many in vivo and in vitro studies of dietary seaweed report decreased angiogenesis and increased apoptosis of tumor cells (Konishi et al. 2006; Koyanagi et al. 2003; Sekiya et al. 2005), inhibition of tumor cell adhesion and metastasis (Liu et al. 2005) and enhanced immune responses (Maruyama et al. 2003; Maruyama et al. 2006). Nishino and colleagues have investigated seaweed modulation of the urokinase plasminogen system (Nishino et al. 1999; Nishino et al. 2000). Based on the wide range of antitumor effects, we investigated the possibility that seaweed could affect uPAR concentrations in women who consume seaweed. The urokinase-type plasminogen activator (uPA), urokinase-type plasminogen activator receptor (uPAR, CD87), and its plasminogen inhibitors 1 and 2 are central to the maintenance of homeostasis, directly affecting the extracellular matrix (ECM), inflammation, tissue repair. Increased concentrations have been shown to be associated with more rapid cancer progression (Foekens et al. 2000). Urinary concentration of uPAR is highly correlated with urinary uPA concentrations, and both are correlated with tissue concentration (Foekens et al. 2000; Sier et al. 2004).When uPA/uPAR concentrations are increased, there is increased ECM degradation that allows cancer cells to migrate, leading to metastases. Urokinase is also used therapeutically to treat serious conditions involving blood clots. In clinical studies, tissue concentration of uPA is an independent prognostic predictor of BC progression (Ceccarelli et al. 2010; Look et al. 2002).

We therefore included evaluation of one part of the urokinase system, uPAR, in this study as a possible biomarker for seaweed activity that might be related to BC prevention.

To further assess whether a dietary seaweed intervention could alter protein expression in urine and serum in a non-seaweed consuming population of healthy postmenopausal women, we used surface enhanced laser desorption/ionization time of flight coupled with mass spectrometer (SELDI-TOF-MS). Proteomic analyses have been used to identify cancer biomarkers with high sensitivity and specificity, including those related to BC (Gast et al. 2008; Shimizu et al. 1991; van Winden et al. 2009). SELDI has also been shown to be sensitive enough to be used to identify changes in serum associated with the addition of a novel food (green tea) (Tsuneki et al. 2004).

Dietary Seaweed and Early Breast Cancer: A Randomized Trial

SELDI-TOF-MS was used to measure urinary and serum protein changes

Urinary iodine concentration changes were used to indicate adherence to taking the seaweed supplement.

U.S. Army Medical Research and Development Command

University of South Carolina

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Amino Acids

Vitamins

Pemetrexed

Cisplatin

Mitogens

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine

Folinic Acid

Folate

Vitamin B9

Drug: Sintilimab 200mg IV Q3W Other Name: IBI308

Drug: IBI305 15mg/kg IV Q3W

Drug: Pemetrexed 500mg/m2 IV Q3W

Drug: Cisplatin 75mg/m2 IV Q3W

Drug: Sintilimab 200mg IV Q3W Other Name: IBI308

Drug: Pemetrexed 500mg/m2 IV Q3W

Drug: Cisplatin 75mg/m2 IV Q3W

Drug: Placebo2 Placebo2 IV Q3W

Drug: Pemetrexed 500mg/m2 IV Q3W

Drug: Cisplatin 75mg/m2 IV Q3W

Drug: Placebo1 Placebo1 IV Q3W

Drug: Placebo2 Placebo2 IV Q3W

Sintilimab

IBI305

Placebo1

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.

Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dietary Seaweed and Early Breast Cancer: A Randomized Trial	NCT01663792	Seaweed Associa...	Seaweed Placebo Placebo2	45 Years - 68 Years	University of South Carolina
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure	NCT03802240	Non-Squamous No...	Sintilimab IBI305 Pemetrexed Cisplatin Placebo1 Placebo2	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure	NCT03802240	Non-Squamous No...	Sintilimab IBI305 Pemetrexed Cisplatin Placebo1 Placebo2	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure	NCT03802240	Non-Squamous No...	Sintilimab IBI305 Pemetrexed Cisplatin Placebo1 Placebo2	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Dietary Seaweed and Early Breast Cancer: A Randomized Trial	NCT01663792	Seaweed Associa...	Seaweed Placebo Placebo2	45 Years - 68 Years	University of South Carolina

Spots Global Cancer Trial Database for placebo2

Every month we try and update this database with for placebo2 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 placebo2

Every month we try and update this database with for placebo2 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 placebo2 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.