diagnosed with histologically confirmed ESCC

without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases

Esophageal Squamous Cell Carcinoma

UNC Project, Lighthouse Trust

UNC Project

HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi

LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi

To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: HIV infection, PAH exposure, Dietary factors including fumonisin and selenium, Scalding hot beverages and foods, Tobacco and alcohol consumption

To assess survival after ESCC diagnosis in Malawi.

To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: HIV infection

To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: PAH exposure

To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Dietary factors including fumonisin and selenium

To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Scalding hot beverages and foods

To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Tobacco and alcohol consumption

To identify and characterize common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.

To identify and characterize germline genetic and epigenetic alterations associated with susceptibility to ESCC.

UNC Lineberger Comprehensive Cancer Center

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.

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.

Placebo

Total

Sex: Female, Male

Region of Enrollment

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

AFB1-lysine Adduct (pg/mg) Overtime

Overall Study

Dr. Bradley H. Pollock, PI

Dietary Carcinogenesis

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.

fumonisin/rak

HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi

Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100"

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