The antidiarrheal efficacy of a proprietary amino acid mixture in neuroendocrine tumor (NET) patients.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 218-218
Author(s):  
Laura Luque ◽  
Aman Chauhan ◽  
Qian Yu ◽  
Rachel C Miller ◽  
Heidi Weiss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Amino Acid ◽  
Neuroendocrine Tumor ◽  
Phase Ii ◽  
Somatostatin Analogs ◽  
The United States ◽  
Acid Mixture ◽  
Tumor Patients ◽  
Short Gut Syndrome

218 Background: Gastroenteropancreatic neuroendocrine tumor (GEPNET) incidence has risen 6-fold over past 3 decades. North American Neuroendocrine Tumor Society estimates that over 100,000 GEPNET patients are currently living in the United States. One of the common quality of life limiting symptom seen in GEPNET patient is diarrhea. Diarrhea in these patients could be due to excessive serotonin production, secondary to post-operative short gut syndrome, steatorrhea from somatostatin analogs, bile acid colitis or intestinal bacterial overgrowth. A novel amino acid based oral rehydration solution (enterade) is currently being evaluated in a Phase II clinical trial for antidiarrheal effects in post bone marrow transplant patients (NCT02919670). We conducted a pilot study of enterade in neuroendocrine tumor (NET's) patients with quality of life limiting diarrhea. Methods: Medical records of all the NET patients given enterade to alleviate symptomatic diarrhea were evaluated. Patients were treated at Markey Cancer Center between May 2017-June 2018. Results: Total 69 NETs patients were treated with enterade. Enterade was administered as 8 Oz bottle BID for 1 a week. Antidiarrheal efficacy data was available on 41 patients at the time of abstract submission. 15 patients had small bowel NETs, 5 had bronchial NETs, 1 had colorectal NETs, 3 had NETs of unknown primary, 3 had gastric NETS, 3 had pancreatic NETs and one had high grade neuroendocrine carcinoma of the prostate. Data regarding primary site was unavailable in 10/41 patients. 21 patients had history of prior bowel resection either for primary neuroendocrine tumor resection or debulking. 25 patients were on somatostatin analogs at the time of initiation of enterade. 31 out of 41 patients reported some reduction in diarrhea frequency. 21 out of these 41 patients reported at least a 50% reduction in diarrhea frequency. Conclusions: 75.6% (31/41) neuroendocrine tumor patients reported improvement in diarrhea frequency with enterade. 51.2% (21/41) reported more than 50% reduction in diarrhea frequency. A prospective Phase II study of enterade in neuroendocrine tumor patients with quality of life limiting diarrhea is currently planned.

The antidiarrheal efficacy of a proprietary amino acid mixture in gastroenteropancreatic neuroendocrine patients.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 509-509 ◽  
Author(s):  
Aman Chauhan ◽  
Rachel C Miller ◽  
Qian Yu ◽  
Bilal Aslam ◽  
Heidi Weiss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Amino Acid ◽  
Neuroendocrine Tumor ◽  
Phase Ii ◽  
Somatostatin Analogs ◽  
The United States ◽  
Acid Mixture ◽  
Tumor Patients ◽  
Gastroenteropancreatic Neuroendocrine Tumor

509 Background: Based on SEER database, gastroenteropancreatic neuroendocrine tumor incidence has increased 6 fold from 1 in 100,000 cases to about 6 in 100,000 cases over past 3 decades. North American Neuroendocrine Tumor Society estimates that over 100,000 GEPNET patients are currently living in the United States. One of the common quality of life limiting symptom seen in GEPNET patient is diarrhea. Diarrhea in these patients could be due to excessive serotonin production, secondary to post-operative short gut syndrome, steatorrhea from somatostatin analogs, bile acid colitis or intestinal bacterial overgrowth. A novel amino acid based oral rehydration solution (Enterade) is currently being evaluated in a Phase II clinical trial for antidiarrheal effects in post bone marrow transplant patients (NCT02919670). We conducted a pilot study of Enterade in neuroendocrine tumor patients with quality of life limiting diarrhea to evaluate its antidiarrheal efficacy. Methods: Medical records of all the GEPNET patients treated with Enterade for symptomatic diarrhea were evaluated. Patients were treated at Markey cancer center between May 2017-August 2017. Results: Total 8 patients were treated with Enterade. Five were small bowel NETs and 3 were pancreatic NETs. Five patients had prior bowel resections for removal of primary tumor; 5 patients were on somatostatin analogs at the time of initiation of Enterade. Five (62%) patients reported improvement in diarrhea within 6 days of initiating Enterade. The responders had 50 % reduction in their stool output. Mean stools dropped from 6 per day to 3 per day in responders. Conclusions: These pilot data suggest that Enterade may be an effective option in diarrhea control in NET patients. A prospective Phase II study of Enterade in gastroenteropancreatic neuroendocrine tumor patients with quality of life limiting diarrhea is planned.

The antidiarrheal efficacy of a proprietary amino acid mixture (enterade) in neuroendocrine tumor (NET) patients: Updated data.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 614-614
Author(s):  
Aman Chauhan ◽  
Rachel C. Miller ◽  
Laura Luque ◽  
Heidi Weiss ◽  
Lowell Brian Anthony
Keyword(s):  
Quality Of Life ◽  
Neuroendocrine Tumor ◽  
Somatostatin Analogs ◽  
Tumor Resection ◽  
Bacterial Overgrowth ◽  
Unknown Primary ◽  
Acid Mixture ◽  
Tumor Patients ◽  
Short Gut Syndrome

614 Background: Diarrhea is a common quality of life limiting symptom seen in neuroendocrine tumor patient. Diarrhea in these patients could be due to excessive serotonin production, secondary to post-operative short gut syndrome, steatorrhea from somatostatin analogs, bile acid colitis or intestinal bacterial overgrowth. In this study we summarize our single center experience with enterade. Methods: Medical records of all the NET patients treated with enterade for symptomatic diarrhea were retrospectively reviewed after appropriate IRB approval. Patients were treated at Markey cancer center between May 2017-June 2019. Results: Total 98 patients were offered enterade. enterade was instructed to be taken as one 8 Oz bottle BID for 1 week. Antidiarrheal efficacy data was available on 49 patients at the time of abstract submission. 37 (75%) patients had GEPNETs, 8 had bronchial NETs, 1 gynecological NET and 3 patients had unknown primary. 28 (57%) patients had history of prior bowel resection either for primary neuroendocrine tumor resection or debulking. 28 (57%) patients were on somatostatin analog at the time of initiation of enterade. 42 (85%) out of 49 patients reported subjective improvement in diarrheal symptoms. 27 (64%) out of these 42 responders reported at least 50 percent reduction in diarrhea frequency. Conclusions: 85% (42/49) neuroendocrine tumor patients reported improvement in diarrhea with enterade. 64% (27/42) reported more than 50% reduction in diarrhea frequency. A prospective Phase II study of enterade in neuroendocrine tumor patients with quality of life limiting diarrhea is currently being conducted (NCT03722511).

scholarly journals Can an amino acid mixture alleviate gastrointestinal symptoms in neuroendocrine tumor patients?

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Aman Chauhan ◽  
Satya Das ◽  
Rachel Miller ◽  
Laura Luque ◽  
Samuel N. Cheuvront ◽  
...  
Keyword(s):  
Amino Acid ◽  
Neuroendocrine Tumor ◽  
Gastrointestinal Symptoms ◽  
Retrospective Chart Review ◽  
Final Analysis ◽  
Acid Mixture ◽  
Tumor Patients ◽  
Short Gut Syndrome ◽  
Oral Rehydration ◽  
The Mean

Abstract Background Neuroendocrine tumors, although relatively rare in incidence, are now the second most prevalent gastrointestinal neoplasm owing to indolent disease biology. A small but significant sub-group of neuroendocrine tumor patients suffer from diarrhea. This is usually secondary to carcinoid syndrome but can also be a result of short gut syndrome, bile acid excess or iatrogenic etiologies. Recently, an amino acid based oral rehydration solution (enterade® Advanced Oncology Formula) was found to have anti-diarrheal properties in preclinical models. Methods A retrospective chart review of all NET patients treated with enterade® AO was performed after IRB approval. Results Ninety-eight NET patients who had received enterade® AO at our clinic from May 2017 through June 2019 were included. Patients (N = 49 of 98) with follow up data on bowel movements (BMs) were included for final analysis. Eighty-four percent of patients (41/49) had fewer BMs after taking enterade® AO and 66% (27/41) reported more than 50% reduction in BM frequency. The mean number of daily BMs was 6.6 (range, 3–20) at baseline before initiation of therapy, while the mean number of BMs at 1 week time point post enterade® AO was 2.9 (range, 0–11). Conclusions Our retrospective observations are encouraging and support prospective validation with appropriate controls in NET patients. This is first published report of the potential anti-diarrheal activity of enterade® AO in NET patients.

scholarly journals Phase II study of Ginkgo biloba in irradiated brain tumor patients: effect on cognitive function, quality of life, and mood

2012 ◽  
Vol 109 (2) ◽  
pp. 357-363 ◽  
Author(s):  
Albert Attia ◽  
Stephen R. Rapp ◽  
L. Doug Case ◽  
Ralph D’Agostino ◽  
Glenn Lesser ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Brain Tumor ◽  
Cognitive Function ◽  
Phase Ii ◽  
Ginkgo Biloba ◽  
Phase Ii Study ◽  
Tumor Patients

Phase II Study of Donepezil in Irradiated Brain Tumor Patients: Effect on Cognitive Function, Mood, and Quality of Life

2006 ◽  
Vol 24 (9) ◽  
pp. 1415-1420 ◽  
Author(s):  
Edward G. Shaw ◽  
Robin Rosdhal ◽  
Ralph B. D'Agostino ◽  
James Lovato ◽  
Michelle J. Naughton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Brain Tumor ◽  
Cognitive Functioning ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Acetylcholinesterase Inhibitor ◽  
Tumor Patients ◽  
Health Related Qol ◽  
Health Related

Purpose A prospective, open-label phase II study was conducted to determine whether donepezil, a US Food and Drug Administration–approved reversible acetylcholinesterase inhibitor used to treat mild to moderate Alzheimer’s type dementia, improved cognitive functioning, mood, and quality of life (QOL) in irradiated brain tumor patients. Patients and Methods Thirty-four patients received donepezil 5 mg/d for 6 weeks, then 10 mg/d for 18 weeks, followed by a washout period of 6 weeks off drug. Outcomes were assessed at baseline, 12, 24 (end of treatment), and 30 weeks (end of wash-out). All tests were administered by a trained research nurse. Results Of 35 patients who initiated the study, 24 patients (mean age, 45 years) remained on study for 24 weeks and completed all outcome assessments. All 24 patients had a primary brain tumor, mostly low-grade glioma. Scores significantly improved between baseline (pretreatment) and week 24 on measures of attention/concentration, verbal memory, and figural memory and a trend for verbal fluency (all P < .05). Confused mood also improved from baseline to 24 weeks (P = .004), with a trend for fatigue and anger (all P < .05). Health-related QOL improved significantly from baseline to 24 weeks, particularly, for brain specific concerns with a trend for improvement in emotional and social functioning (all P < .05). Conclusion Cognitive functioning, mood, and health-related QOL were significantly improved following a 24-week course of the acetylcholinesterase inhibitor donepezil. Toxicities were minimal. We are planning a double blinded, placebo-controlled, phase III trial of donepezil to confirm these favorable results.

Amino acid mixture (enterade) as a new approach to reducing cancer therapy-induced gastrointestinal toxicity: A retrospective study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24107-e24107
Author(s):  
Aman Chauhan ◽  
Reema Anil Patel ◽  
Laura Luque ◽  
Holly Chitwood ◽  
Fariha Siddiqui ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Amino Acid ◽  
Cancer Therapy ◽  
Phase Ii ◽  
Previous History ◽  
Amino Acid Mixture ◽  
Gastrointestinal Toxicity ◽  
Acid Mixture ◽  
Tumor Patients ◽  
Patient Reported

e24107 Background: Gastrointestinal toxicity is a common side effect of cancer therapy. Pre-clinical studies using a proprietary mixture of amino acids, demonstrated a reduction in mucositis and gastrointestinal toxicity following irradiation via tightening of the mucosal barrier, increasing proliferation of crypt cells, increasing villous height and increasing absorption of fluid, electrolytes and nutrients. A novel 5-amino acid mixture “enterade” was previously evaluated in a Phase II clinical trial for anti-diarrheal effects in post bone marrow transplant patients at Dana Farber Cancer Institute (NCT02919670). Signs of anti-diarrheal efficacy were found in treatment-compliant patients.Enterade is currently being tested in two prospective Phase II studies (NCT03722511 and NCT04073017) in neuroendocrine tumor patients with quality of life limiting diarrhea. We conducted a pilot study to evaluate early antidiarrheal signals in oncologic treatment-induced diarrhea. Methods: An IRB-approved retrospective chart review was conducted at Markey Cancer Center between Sept 2019 and Dec 2019. Medical records were retrospectively reviewed for all solid tumor patients who received enterade for chemotherapy or immunotherapy-induced diarrhea. Patients were instructed to consume one 8-oz bottle of enterade twice a day for at least one week in addition to standard of care antidiarrheal medications. Results: A total of 46 patients were offered enterade. Antidiarrheal efficacy data was available on 17 patients. 11 were female and the mean age of the cohort was 64 years. Six out of 17 patients had a previous history of bowel resection. Four patients had immune checkpoint induced colitis. Three patients developed diarrhea from TKI use and rest were on cytotoxic chemotherapy at the time of the diarrheal episode. Eighty-eight percent (15/17) of patients reported a reduction in diarrhea frequency after consuming enterade. On average, patients noticed an improvement in diarrhea frequency after 3.6 days of enterade consumption, with 86% (13/15) of responders reporting at least 50% reduction in diarrhea frequency. Conclusions: Patient-reported diarrheal improvement after enterade consumption is consistent with pre-clinical data. Results suggest the amino acid mixture may alleviate symptoms of cancer therapy-induced gastrointestinal toxicity (i.e. diarrhea). A prospective clinical trial is warranted to substantiate the observed improvement in chemotherapy and immunotherapy induced diarrhea.

Association between duration of somatostatin analogs (SSAs) use and quality of life in patients with carcinoid syndrome in the United States based on the FACT-G instrument.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15693-e15693
Author(s):  
Daniel M. Halperin ◽  
Lynn Huynh ◽  
Jennifer L Beaumont ◽  
Beilei Cai ◽  
Todor Totev ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Carcinoid Syndrome ◽  
Reference Group ◽  
Descriptive Analysis ◽  
Somatostatin Analogs ◽  
Well Being ◽  
The United States ◽  
Number Of Patients ◽  
The Mean

e15693 Background: Carcinoid syndrome (CS) results from the secretion of bioactive amines by functional neuroendocrine tumors. The only FDA-approved agents to treat carcinoid syndrome symptoms (CSS) are SSAs. This study assessed the association of duration of SSA use and quality of life (QoL) among patients with CSS usingthe validated Functional Assessment of Cancer Therapy-General (FACT-G) instrument. Methods: Patients with CSS in the US were recruited by NCAN for a two-part online, anonymous survey (~6 months apart). The first survey was fielded between July-October 2016 and results are reported here. Eligible patients were ≥18 years old with CSS and received either SSA or non-SSA treatment for CSS control. The survey consisted of demographic, clinical and QoL questions, including FACT-G. Descriptive and multivariable regression analyses, adjusting for demographic and clinical characteristics, were performed to assess predictors of FACT-G QoL scores. Duration of SSA use was categorized into quartiles ( < 2.7, 2.7-4.42, 4.43-8.0, and > 8.0 years). Results: Among 117 patients who completed the first survey, 76.9% were female and 87.2% Caucasian with a mean age of 58.0 years. A predominant number of patients (98.3%) received SSAs in the past month. The mean ± SD FACT-G total score was 67.6 ± 20.0 (possible range: 0-108), lower than that of the general US population (80.1 ± 18.1). The mean ± SD duration of SSA use was 6.1 ± 4.7 years. Descriptive analysis suggested that patients receiving SSA treatment for > 8 years had higher (better) FACT-G subscale and total scores than reference group < 2.7 years. Multivariable models showed that FACT-G total score was 11.3 points ( P= 0.033) higher for patients treated with SSA > 8 years compared to those treated for < 2.7 years. Similar patterns were observed for two FACT-G subscales - Physical Well Being and Functional Well Being. Conclusions: The duration of SSA use was positively associated with QoL benefit among CS patients. This may be explained by long-term effectiveness of SSAs or selection bias favoring patients with more indolent disease. Future studies will be needed to distinguish between these possibilities.

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