Neoplasms

Symptoms and General Pathology

All Conditions

Substance Related Disorders

Carcinogenesis

Aflatoxin Poisoning

Neoplastic Processes

All Drugs and Chemicals

Gastrointestinal Agents

Bone Density Conservation Agents

Calcium

Calcium Carbonate

Calcium, Dietary

Antacids

Anti-Ulcer Agents

Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.

Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.

Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.

ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.

ACCS100

Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.

Placebo

Bradley H Pollock, MPH, Ph.D.

The primary purpose of the study is to evaluate the effectiveness of a naturally occurring clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen) and fumonisin (a cancer promoter). This clay substance contains of a variety of minerals including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate minerals have been regularly used as dietary supplements by humans and animals, and the safety of this naturally occurring clay substance has been tested in clinical trials. The FDA treats such minerals or nutritional supplements as a drug when tested for potential of lessening the likelihood of disease (i.e., potential for mitigating disease).

This study involves the use of an investigational drug called Hydrated Sodium Calcium Aluminosilicate (ACCS100). "Investigational" means that the "drug" has not yet been approved by the U.S. Food \& Drug Administration (FDA) for reducing harmful effects mycotoxin exposure in humans.

This planned clinical trial is a comparative study to determine the safety and effectiveness of ACCS100 capsules, the investigational product, vs. placebo in participants for the reduction of dietary mycotoxin exposure. One measure of effectiveness will be the analysis of the Bexar County participant's AFB1/FB1 metabolite levels in the blood and urine samples. Additionally, this clinical trial will determine the adherence to the dosing schedule of the participants; determine the prevalence of mycotoxin exposure in the screened population of residence of Bexar County, Texas; and compare side-effects and adverse events between ACCS100 and placebo in the participant population. These data will reveal the value of mineral enterosorbent strategies for the improvement of public health and for the well-being of humans at risk for dietary mycotoxin exposure and its consequences.

The proposed indication for ACCS100 is "for the reduction of dietary mycotoxin exposure in humans."

ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate (HSCAS), a substance generally recognized as safe (GRAS) by the FDA and has previously been shown to have no significant adverse effects when given as much as 4 grams per day to healthy study participants or immuno-compromised cancer patients.

Rationale

Our preliminary studies suggest that ACCS100 contains very low levels of trace metals and dioxins than are commonly found in smectite clays, and batch-to-batch QA/QC results for this material are more consistent. We anticipate that ACCS100 can be used as a primary intervention to bind both AFB1 and FB1 to decrease the external dose of toxins from the diet and in turn reduce the incidence of hepatic cancer and disease in vulnerable communities. Using multiple animal models, our laboratory has shown that NS clay is highly effective in preventing the adverse effects of dietary mycotoxin. Also, Phase I and IIa clinical trials in Texas and Ghana have confirmed that NS is safe for human consumption and significantly reduces exposure to both AFB1 and FB1 (Wang et al., 2005; Afriyie-Gyawu et al., 2007, 2008; Wang et al., 2008; Phillips et al., 2007; Jiang et al., 2008; Jolly et al., 2006; Robinson, et al., 2009). The incidence of human HCC has been shown to be significantly elevated in several zip code regions in Bexar County, Texas. Studies conducted by the Agency for Toxic Substances and Disease Registry indicate that there are several zip code regions within Bexar County, Texas where the incidence of liver cancer is significantly elevated (ATSDR, 2004). Notably, age-adjusted cancer incidence rates cited by the Texas Department of State Health Services from 2002-2006 show that Hispanics in Bexar Co. have an increased HCC incidence rate, 16.5 (15.0-18.0), compared to Hispanics in Texas, 10.9 (10.4-11.4); rates are per 100,000, and confidence intervals are 95% for rates. Furthermore, the HCC incidence rate for Bexar Co. Hispanics was considerably higher than all races in Bexar Co., 10.0 (9.2-10.8), and all races in Texas, 5.8 (5.7-6.0). Hispanic males in Bexar County (compared to females) were shown to have the highest HCC incidence rate during this time period, at 27.1 (24.2-30.2) versus 8.4 (7.0-9.9). Chronic exposure to low levels of AFB1 and FB1 contaminated corn and peanuts, is a major risk factor for the development of HCC, and risk is significantly increased when exposed individuals are infected with hepatitis virus. An association between HCC incidence and hepatitis C virus (HCV) infection has been evident in many developed countries including the U.S., Japan, Egypt, and numerous countries in Europe (Seeff, 2004). Interestingly, records from the University of Texas M.D. Anderson Cancer Center have shown that more than 50% of the HCC cases observed in Texas could be attributed to HCV infection (Hassan, et al., 2002). The HCV prevalence in Texas has been reported to vary from 1.25-2.63%, with higher concentrations in southern Texas and along the Texas-Mexico border (Yalamanchili, et al., 2005). Armstrong et al. (2000) estimated that in the future HCC incidence may rise in the U.S. due to the problem of chronic hepatitis C. While prevention of HCV infection would play a major role in reducing the burden of HCC, currently no vaccine is available for HCV. Thus, eliminating AFB1/FB1 exposure at an individual level (in the most vulnerable individuals), may contribute to the overall reduction of HCC risk and burden. In our recent pilot study, 184 volunteers from a primarily Hispanic community within three zip codes in Bexar Co. (with a significantly elevated liver cancer incidence rate) provided blood and urine samples for hepatitis screening and biomarker analyses at the San Antonio Metropolitan Health District (SAMHD) Environmental Health and Wellness Center (Figure 2). Of the participants, 7.1% were hepatitis C virus positive, based on anti-HCV antibody measurement. To assess short-term AFB1 exposure, urinary aflatoxin M1 (AFM1) levels were measured using high performance liquid chromatography with fluorescence detection. AFM1 was detectable in 11.7% of urine samples, with the average level at 223.85 ± 250.56 (range 1.89-935.49) pg/mg creatinine. Results from a food frequency questionnaire showed that over 98% of participants reported that they ate fresh corn, canned or frozen corn, corn tortillas, Mexican food, rice, peanut butter, corn bread, and nuts at various frequencies. A large percentage of the population (44.8%) consumed corn tortillas frequently (3-14 times per week), and the majority (57.6%) ate more than 2 tortillas at each time of consumption. The detection of urinary AFM1 was significantly associated with an increased consumption of tortillas (p = 0.009), peanuts (p = 0.033) and rice (p = 0.037). Findings suggested that participants consuming high amounts of foods prone to AFB1/FB1 contamination may potentially be exposed to these toxins at significant levels. Importantly, strategies that reduce AFB1/FB1 exposure, especially in individuals infected with hepatitis, may play an important role in the prevention of HCC in at-risk communities in Texas. These preliminary studies provide the groundwork and proof of concept for the proposed project. Feasible interventions and therapies to diminish human exposure to AFB1/FB1 are imperative. In this proposal, studies will provide an innovative strategy that will reduce dietary mycotoxin exposure. Our approach will utilize ACCS100 to mitigate dietary exposures to AFB1 (a cancer initiator) and FB1 (a cancer promoter).

Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"

"Phase II, Reduction of Dietary Mycotoxin Exposure in Persons in Bexar County, Texas by Ingestion of ACCS100 Capsules Compared to Placebo."

Study submitted for publication in Tier 1 Toxicology Journal

After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.

Texas A&M University

University of Georgia

The University of Texas at San Antonio

Texas Enterosorbents Incorporated

Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.

ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.

ACCS100 High Dose

Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.

ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.

ACCS100 Low Dose

Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.

Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Participants had detectable levels of aflatoxin in serum sample and were otherwise healthy.

Unlike our clinical trials in Africa, where maximum compliance was achieved through the daily in-home monitoring, the current study relied on participant reports during monthly visits in which total compliance was difficult to assess.

Dr. Bradley H. Pollock, PI

Baseline

Week 4

Week 12

Week 16

AFB1-lysine Adduct (pg/mg) Overtime

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

150 Women without breast cancer, aged from 25 to 50 years old

6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention

Precam

Ruben Martin Payo, PhD

Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias.

Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. Informed consent signed.

Variables: personal characteristics (age, status, educational level, occupation), MIC index, dietary characteristics, level of physical activity, presence of known risks of breast cancer (number of children, breastfeeding, oral contraceptives, family history of cancer, previous cancer, breast density and knowledge related with breast cancer prevention.

Intervention:

* Intervention Group:6 months intervention using a web-app related with personal care and breast cancer risks, diet and physical activity.
* Control Group: no intervention.

Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias.

Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. They are recluted for a previous study developed by the same research team. An information document and a written consent was given for the women. Those who signed the consent are included.

The randomization for intervention or control group are doing based on the where the city where the women home is located. the objective of this distribution is to avoid contact between women from different groups.

Variables: personal characteristics (age, status, educational level, civil status), MIC index, dietary characteristics, level of physical activity, knowledge related with breast cancer symptoms and risk factors.

Intervention:

The 6 months intervention are going to be developed using a web-app. The intervention is based on the Behavior Change Wheel model. Capacity and motivation are going to be the determinants on which it will work using for it interventions based on education, persuasion and modeling among others.

Intervention Group: 6 months intervention using a web-app related. The web-app includes some sections:

* Information related with breast cancer risk.
* Breast self examination. Written text and videos done by a nurse.
* Physical exercise. Written text and videos done by a physiotherapist .
* Dietary information. Written text and videos done by a nutrition expert.

The Control Group are not going to receive intervention during the study period time. After that, women are going to be access to the web-app.

Statistical analysis

Descriptive statistics will be carried out (means, standard deviation, CI and percentages). In addition, at the end of the study, in order to determine the factibility of the educational intervention, the variation of the intra-group data (from pre to psot-test) and between the groups in post-test will be compared using the chi-square test. , t-student or Mann-Whitney U, for qualitative or quantitative data respectively.

Breast Cancer: Feasibility of an Educational Intervention

Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application

Anonymizes data are going to be published but we are not going to analizase individual data.

Participants that finish the intervention

People that did not finish the intervention

Mean number of recommendations done by the participants

Using 2 dimensions of MARA questionnaire (Scale title)1) knowledge of risk factors of breast cancer (range 0=worst score to 9=better score); 2) knowledge of signs and symptoms of breast cancer (range 0=worst score to 9=better score)

University of Oviedo

Principal Investigator

Adverse Events were not monitored/assesed

Intervention Group

Control Group

Race (NIH/OMB)

Spain

Studies

Civil status

Vicerrectorado de investigación

Feasibility of an Educational Intervention: Adherence to the Intervention

Intervention

Control

Feasibility of an Educational Intervention: Drop Out After the Intervention Period

150 Women without breast cancer, aged from 25 to 50 years old

Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention

Number of Diet and Activity Recommendations

Risk factors knowledge

Symptoms knowledge

Breast Cancer Awareness

Precam Group (Intervention Group)

Participants receiving written dietary recommendations for breast cancer survivors (control arm)

Participants attending Cocinar Para Su Salud Program held over a 12-week period

A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.

Cocinar Para Su Salud Program

Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver

Written dietary recommendations

Heather Greenlee, ND, PhD

Hispanic women are 20% more likely to die of breast cancer than non Hispanic white women who are diagnosed at a similar age and stage. One reason for this disparity may be differences in post diagnosis dietary behaviors. In order to reduce this disparity, and to improve overall survivorship, culturally appropriate dietary interventions that teach women how to eat a diet high in fruits and vegetables and low in saturated fat need to be developed for Hispanic breast cancer survivors. The investigators propose to conduct a randomized controlled study (n=70, 35 per arm) to test the effects of the ¡Cocinar para su salud! program on changing dietary behaviors among Hispanic breast cancer survivors who have recently completed treatment. The ¡Cocinar para su salud! program is a 12 week course that provides hands on education and instruction in nutrition education, meal preparation, and food shopping in a group setting. All participants will be followed for a total of 12 months, have clinical assessments at baseline, 6 months, and 12 months, and monthly telephone contacts using motivational interview techniques. The Primary Aims are to determine the effect of the dietary intervention (¡Cocinar para su salud! program) vs. control (standard written nutrition education materials for cancer survivors) on 1) daily servings of fruit/vegetable, and 2) daily servings of fat intake from baseline to 6 months. The investigators hypothesize that the dietary intervention will result in a larger increase of fruit and vegetable intake and a larger reduction of fat intake, when compared to the control group. Secondary Aims are to determine the effect of the dietary intervention vs. control on 1) biomarkers of fruit and vegetable intake, molecular biomarkers associated with breast cancer risk, and anthropometric measures at 6 and 12 months; 2) fruit/vegetable and fat intake at 12 months; 3) mediators of dietary change, including readiness to change, outcome expectations, perceived self efficacy, food and nutrition skills, self regulation skills, and barriers to adherence; and 4) changes in quality of life and anxiety/depression at 6 and 12 months.

This trial is a randomized, controlled 2-arm study of a 3-month dietary change counseling and instruction intervention among Hispanic breast cancer survivors (n=70, 35 per arm). The study is comparing Arm A: standard of care written dietary recommendations for cancer survivors, with Arm B: the 12-week ¡Cocinar para su salud!. ¡Cocinar para su salud! will provide hands-on education and instruction to Hispanic breast cancer survivors in nutrition education, food shopping, and meal preparation in a group setting. Participants will be followed for a total of 12 months, have clinical assessments at baseline, 6 months, and 12 months, and will have monthly telephone contacts using motivational interviewing. The primary endpoint is at 6 months because the investigators hypothesize that it will take participants at least 3 months to adapt some of the dietary behaviors taught in the 3-month intervention.

A total of 70 women with a history of histologically-confirmed early stage breast cancer will be randomized to Arm A or Arm B. Assuming an accrual rate of approximately 2-4 participants per month, the investigators expect to complete enrollment within 24 months.

Cocinar Para su Salud! (Cook for Your Life!)

Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors

Interviewer-administered questionnaire to assess psychosocial parameters, quality of life, and health behaviors

Physical examination including height, weight, BMI, waist:hip ratio

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"	NCT01677195	Dietary Carcino...	ACCS100 Placebo	18 Years - 85 Years	Texas Enterosorbents Incorporated
Breast Cancer: Feasibility of an Educational Intervention	NCT04396665	Women's Health:...	Precam	25 Years - 50 Years	University of Oviedo
Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"	NCT01677195	Dietary Carcino...	ACCS100 Placebo	18 Years - 85 Years	Texas Enterosorbents Incorporated
Cocinar Para su Salud! (Cook for Your Life!)	NCT01414062	Breast Cancer	Cocinar Para Su... Written dietary...	21 Years -	Columbia University

Spots Global Cancer Trial Database for dietary

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

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