Neoplasms

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Diarrhea

Carcinoma

Carcinoma, Neuroendocrine

Endocrine System Diseases

Signs and Symptoms, Digestive

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Gastrointestinal Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Loperamide

Antidiarrheals

Calcium

Calcium, Dietary

Calcium Aluminosilicate

After a 1 week run-in period CASAD will be administered TID for 1 week. Each dose will be 2 500mg CASAD capsules. Patients will be followed for two weeks post active drug administration.

CASAD

Maria E Cabanillas, MD

Ramona Dadu, MD

Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.

The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

To evaluate the efficacy of CASAD 3 grams per day in reducing the severity of diarrhea after 1 week of treatment in patients with MTC.

To explore the functional impact of CASAD and the relative impact of diarrhea in relation to other symptom issues using MDASI-THY (M.D. Anderson Symptom Inventory-Thyroid, appendix D)

To explore the effect of CASAD on thyroid function tests, thyroid hormone and calcium absorption

To examine changes in MDASI-THY scores after treatment with CASAD

Salient Pharmaceuticals Incorporated

Emergencies

Disease Attributes

Hormones

CASAD 1 gram orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.

Placebo orally every 6 hours for up to 6 days. Questionnaire completion at baseline about diarrhea and other symptoms.

1 gram by mouth every 6 hours for up to 6 days.

Calcium Alumina-Silicate (CASAD)

1 by mouth every 6 hours for up to 6 days.

Placebo

Questionnaire completion at baseline about diarrhea and other symptoms.

Questionnaire

Sai-Ching J. Yeung, MD,PHD

The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can help to stop your diarrhea. Researchers also want to know if this drug can help decrease the duration of your diarrhea.

In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study drug to learn if the study drug has any real effect.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either CASAD orally or a placebo. You will have an equal chance of being assigned to either group.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Treatment:

You take either CASAD or placebo by mouth every 6 hours with about 1 cup (8 oz.) of water. You will also be given other supportive care and treatment for diarrhea (such as imodium and lomotil).

You will be asked to keep a journal, which includes a record of the time you take the study drug each day and a history of your bowel movements every day you take CASAD or placebo.

Study Visits:

Before the dose:

* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be recorded.
* You will be asked when your diarrhea started.
* You will be asked about any drugs you have taken for the cancer and diarrhea.
* A stool sample will be collected to test for toxins.
* Blood (about 1 teaspoon) will be drawn to measure cytokines (proteins that may affect the immune system and inflammation) .
* You will be asked about your diarrhea and other symptoms. It should take about 5 minutes to answer these questions.

At the same visit after the dose:

* You will have a physical exam, including measurement of your vital signs.
* You will be asked about your diarrhea.
* You will be asked if you have any side effects.

On Day 1 (the day after your visit to the Emergency Center):

-Blood (about 1 teaspoon) will be drawn to check your electrolytes and to measure cytokines and inflammation (optional).

On Days 2-6 (this will be by phone or the staff will visit you if you are in the hospital):

* You will be asked about your diarrhea.
* You will be asked if you have any side effects.

Length of Treatment:

You will take the study drug or placebo for up to 6 days or when the diarrhea stops, whichever happens first. You will no longer be able to take the study drug or placebo if the diarrhea gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Follow-Up:

After you are off study, the study nurse will call you and ask if you have had any other side effects since finishing the study treatment. The phone call should only last about 5 minutes. If you are still an inpatient at the hospital, the study nurse may visit you and ask you these questions in person.

At your next scheduled appointment at MD Anderson, the nurse will meet with you to get your final journal and any unused study drug. If you do not return to MD Anderson, you will receive a self-addressed stamped envelope for you to return this information.

This is an investigational study. CASAD is FDA approved as a food additive, but it has not been approved to treat a disease. Its use to treat diarrhea is investigational.

Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.

CASAD for Severe Diarrhea in the Emergency Department

A Double-Blinded Placebo-Controlled Pilot Trial of Calcium Alumina-Silicate (CASAD) in the Treatment of Severe Diarrhea (Grade 3 or 4) in Cancer Patients Presenting for Emergency Care

The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer	NCT01739634	Diarrhea Medullary Thyro...	CASAD	-	Salient Pharmaceuticals Incorporated
The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer	NCT01739634	Diarrhea Medullary Thyro...	CASAD	-	Salient Pharmaceuticals Incorporated
CASAD for Severe Diarrhea in the Emergency Department	NCT02018653	Cancer Diarrhea	Calcium Alumina... Placebo Questionnaire	18 Years -	M.D. Anderson Cancer Center
The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer	NCT01739634	Diarrhea Medullary Thyro...	CASAD	-	Salient Pharmaceuticals Incorporated

Spots Global Cancer Trial Database for casad

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

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