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 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.

Start Date01 Dec 2013

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT01739634

/ Unknown statusPhase 1/2

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

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.

Start Date01 Nov 2012

Sponsor / Collaborator

Salient Pharmaceuticals, Inc.

NCT01570634

/ TerminatedPhase 2

Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection

Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics.
In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would likely occur in conjunction with neutralization of C. difficile toxins A&B by CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A&M University supports this hypothesis.
The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with C. difficile infection.

Start Date01 Mar 2012

Sponsor / Collaborator

Salient Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Calcium aluminium silicate

100 Translational Medicine associated with Calcium aluminium silicate

100 Patents (Medical) associated with Calcium aluminium silicate

Literatures (Medical) associated with Calcium aluminium silicate

23 Oct 2024·Journal of Lasers in Medical Sciences

Histological Evaluation of Photobiomodulation and Calcium Aluminosilicate on Direct Pulp Capping of Dogs’ Permanent Teeth

Article

Author: Abdelgwad, Marwa ; El Rouby, Dalia ; Mohamed Abdelgawad, Latifa ; Hassan Nghnughi, Mariam

Introduction: Photobiomodulation (PBM) is beneficial to biological tissues; depending on the optical dose that is absorbed by tissues, it can function as a biostimulative, analgesic, and anti-inflammatory mediator. Thus, the current research aimed to assess the impacts of PBM and Calcium aluminosilicate-based material on direct pulp capping (DPC) of dogs’ permanent teeth through histological analysis. Methods: To study DPC of dogs’ teeth, we separated 24 canines and premolars obtained from mature, healthy mongrel dogs into four equal groups: group 1, which served as the control (exposed pulp was covered with a sterile polytetrafluoroethylene, Teflon tape); group 2, which received PBM treatment using a 980 nm diode laser with a 100 mw output power for one minute; group 3: Calcium aluminosilicate-based material; group 4: Calcium aluminosilicate+PBM. In accordance with the assessment period, each group was divided into three equal subcategories: (A) 1 week; (B) 2 months; (C) 3 months. The teeth were evaluated histologically for inflammatory response and dentine bridge formation. Results: Statistical analysis detected that there was a significant difference between PBM, Calcium aluminosilicate cement, and the combination group of PBM and Calcium aluminosilicate related to the control group in variant evaluation periods regarding the inflammatory response and dentine bridge thickness through the histological analysis. In relation to the inflammatory response after one week, the combined group (Calcium silicate cement+PBM) exhibited a significantly decreased intensity of inflammation compared to other groups at an identical time. As for dentin bridge creation, the PBM+calcium aluminosilicate group detected thicker dentine bridge creation at three months than other studied groups. Conclusion: Combined with calcium aluminosilicate-based material, PBM using a 980 nm diode laser with output power of 100 mw for one minute decreased the initial inflammatory response and enhanced a complete thick dentine bridge formation.

01 Oct 2015·Thyroid : official journal of the American Thyroid AssociationQ1 · MEDICINE

Efficacy of the Natural Clay, Calcium Aluminosilicate Anti-Diarrheal, in Reducing Medullary Thyroid Cancer–Related Diarrhea and Its Effects on Quality of Life: A Pilot Study

Q1 · MEDICINE

Article

Author: Ying, Anita ; Sherman, Steven I. ; Busaidy, Naifa L. ; Cabanillas, Maria E. ; Waguespack, Steven G. ; Habra, Mouhammed ; Fox, Patricia ; Cleeland, Charles ; Dadu, Ramona ; Hu, Mimi I.

INTRODUCTION:

Medullary thyroid cancer (MTC)-related diarrhea can be debilitating, reduces quality of life (QOL), and may be the only indication for initiating systemic therapy. Conventional antidiarrheal drugs are not always helpful and may have side effects. Calcium aluminosilicate antidiarrheal (CASAD), a natural calcium montmorrilonite clay, safely adsorbs toxins and inflammatory proteins associated with diarrhea. It was hypothesized that CASAD would reduce the severity of diarrhea and improve QOL in MTC patients.

METHODS:

This was a prospective pilot trial (NCT01739634) of MTC patients not on systemic therapy with self-reported diarrhea of three or more bowel movements (BMs) per day for a week or more. The study design included a one-week run-in period followed by one week of CASAD ± a two-week optional continuation period. The primary endpoint was efficacy of one week of CASAD treatment in decreasing the number of BMs per day by ≥20% when compared with the baseline run-in period. Secondary objectives included tolerability and safety and the impact on QOL using the MD Anderson Symptom Inventory-Thyroid questionnaire (MDASI-THY).

RESULTS:

Ten MTC patients (median age = 52 years, 70% female, 80% white) were enrolled. All had distant metastases, and median calcitonin was 5088 ng/mL (range 1817-42,007 ng/mL). Ninety percent had received prior antidiarrheals, and 40% of these had used two or more drugs, including tincture of opium (30%), loperamide (50%), diphenoxylate/atropine (20%), colestipol (10%), or cholestyramine (10%). Of seven evaluable patients, four (56%) had ≥20% reduction in BMs per day. Six out of seven patients discontinued their prior antidiarrheals. Best response ranged from 7% to 99% reduction in mean BMs/day from baseline. Five out of seven patients considered CASAD a success, and they opted for the two-week continuation period. Improvements in diarrhea and all six interference items assessed by MDASI-THY were noted at weeks 1 and 3. Total interference score was significantly improved at three weeks compared with baseline (p = 0.05). An oral levothyroxine absorption test was performed in one patient; malabsorption of levothyroxine was not observed. Adverse events included flatulence (40%), bloating (10%), heartburn (10%), and constipation (10%).

CONCLUSIONS:

CASAD is a promising strategy for treatment of MTC-related diarrhea. In this small pilot study, improvements in frequency and quality of diarrhea as well as QOL were noted. Further studies in this population are warranted.

01 Mar 2015·Supportive care in cancer : official journal of the Multinational Association of Supportive Care in CancerQ2 · MEDICINE

A phase II, randomized, double blind trial of calcium aluminosilicate clay versus placebo for the prevention of diarrhea in patients with metastatic colorectal cancer treated with irinotecan

Q2 · MEDICINE

Article

Author: Todd Crocenzi ; Sijin Wen ; Katrina Glover ; Ben Esparaz ; Lucas Wong ; Michael James Overman ; Bryan K Kee ; Desiree Jones ; Rebecca S. Slack ; Michael J. Fisch ; Jeffrey Morris

PURPOSE:

Calcium aluminosilicate clay (CASAD) is a naturally occurring clay that serves as a cation exchange absorbent. We hypothesized that oral administration of CASAD would reduce the rate of grade 3/4 diarrhea associated with irinotecan use for metastatic colorectal cancer (CRC) by adsorbing the SN-38 metabolite.

METHODS:

Patients receiving irinotecan-based chemotherapy were randomized equally between CASAD and placebo arms in this multicenter trial in order to assess differences in the proportions of patients with grade 3/4 diarrhea within 6 weeks. Additionally, we compared symptom severity between the two arms using the M.D. Anderson Symptom Inventory.

RESULTS:

Between May 2009 and May 2012, 100 patients were enrolled. In evaluable patients, 7 of 43 (16 %) on the CASAD arm compared to 3 of 32 (9 %) on the placebo arm experienced grade 3/4 diarrhea (P = 0.70). The rate of any diarrhea among all patients was similar (CASAD arm, 64 % vs. placebo arm, 70 %). The rate of study dropout was 14 % in the CASAD arm and 38 % in the placebo arm (P = 0.01). No differences were found in symptom severity, individual symptom items, and in serious adverse events between the two arms.

CONCLUSION:

Compared to placebo, CASAD use was safe but ineffective in preventing diarrhea in metastatic CRC patients treated with irinotecan-containing chemotherapy regimens. There were no distinct signals in terms of patient symptoms between arms, but there was significantly more patient dropout in the placebo arm. Future CASAD trials will focus on the active treatment of diarrhea.

100 Deals associated with Calcium aluminium silicate

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diarrhea	Phase 2	United States	Salient Pharmaceuticals, Inc.	01 Nov 2012
Thyroid Cancer, Medullary	Phase 2	United States	Salient Pharmaceuticals, Inc.	01 Nov 2012
Clostridium difficile diarrhea	Phase 2	United States	Salient Pharmaceuticals, Inc.	01 Mar 2012
Clostridium difficile infection	Phase 2	United States	Salient Pharmaceuticals, Inc.	01 Mar 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02018653 (CTgov)	Not Applicable	Diarrhea \| Neoplasms	2	Questionnaire+Calcium Alumina-Silicate (CASAD) (Calcium Alumina-Silicate (CASAD))	mjrwnvmhfz = pkmkhipzbd idqpekvpoc (idsgmspmxi, rngfddaglq - dnmfnihdxr) View more	-	26 Jul 2018
NCT02018653 (CTgov)	Not Applicable	Diarrhea \| Neoplasms	2	Placebo (Placebo)	mjrwnvmhfz = iowxbyhjpw idqpekvpoc (idsgmspmxi, mpbwhztdpn - qyrnbabfxg) View more	-	26 Jul 2018
NCT01570634 (CTgov)	Phase 2	Clostridium difficile diarrhea \| Clostridium difficile infection	2	Calcium Aluminosilicate Anti-Diarrheal (CASAD)	hqrdblmivl(esmksmvnfc) = fvzxpexaot qxthwyxsbb (umeasrxtrt, cjcyqzdrog - lbwfahccaq) View more	-	08 Mar 2013

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