Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued.

Metastatic Cancer

Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.

Non Chemotherapy

Chemotherapy and target therapy

Chinese herb medicine

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of medicine

Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor

Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor

Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.

Defined as the time from assignment to death from any cause.

Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy

Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response or stable disease to therapy

Drug-related adverse reactions must be recorded, mainly in the following：myelosuppression including neutropenia, anemia and thrombocytopenia;Cardiac toxicity; muscle fatigue, pain, imbalance; Oral ulcers: the patient's gums, cheeks, throat and tongue are prone to ulcers;nausea, vomiting, constipation or diarrhea;hair loss;skin discomfort;hormonal fluctuations, sexual dysfunction, infertility; damage of the kidney;anxiety and depression.

Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.

Through publication after study completion

Haining Health-Coming Biotech Co., Ltd.

Alphacait, LLC

This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.

iPro CGM device will be worn for next 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log (included).
Subjects will undergo MMTT, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.

iPro CGM device will be worn for next 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log (included).
Subjects will undergo MMTT, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.

Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Glucomannan:
For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.
Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.

Baseline Phase (Control), Crossover to Treatment (Glucomannan)

Sex: Female, Male

Region of Enrollment

Percent of time within hypoglycemic blood glucose range (bg<70) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg<70 in treatment condition minus % time with bg<70 in control condition.

Control:
iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.

Baseline Phase (Control) and Treatment Phase (Glucomannan)

Difference Score: Percent of Time Spent in Hypoglycemic State

Percent of time within normal blood glucose limits (bg 70-140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time within normal limits in treatment condition minus % time within normal limits in control condition.

Difference Score: Percent of Time Within Normal Blood Glucose Limits

Percent of time within hyperglycemic blood glucose range (bg>140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg>140 in treatment condition minus % time with bg>140 in control condition.

Difference Score: Percent of Time With Elevated Blood Glucose

Difference score (trt-control) of blood glucose at 120 minutes post meal.

Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)

Difference score (trt-control) of insulin level at 30 minutes post meal.

Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)

Difference score (trt-control) of insulin level at 60 minutes post meal.

Control:
iPro® Continuous Glucose Monitor (CGM) device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.
Glucomannan:
iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.
Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.
glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant.

Overall Study

Dr. Amy Freeth

Hypoglycemia

Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant. It will be given during the Intervention Phase in conjunction with the MMTT and then for 5 days at home with meals.

amorphophallus konjac/antimykotikum

Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor

The Effect of Glucomannan Soluble Fiber on Glucose Homeostasis in Patients With Roux En Y (RNY) Gastric Bypass Surgery

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