Neoplasms

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Digestive System Diseases

Adenocarcinoma

Wasting Syndrome

Cachexia

Exocrine Pancreatic Insufficiency

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Weight

Weight Loss

Body Weight Changes

Thinness

Pancreatic Diseases

Gastrointestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks

Andrew Hendifar, MD, MPH

Abrahm Levi

Andrew Hendifar, MD

Meghan Laszlo, RD

Jun Gong, MD

Gillian Gresham, PhD

Arsen Osipov, MD

Kamya Sankar, MD

The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 40 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.

Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

Pancreatic-enzyme Replacement Therapy With Pancreaze (Pancrelipase) Delayed-release in Addition to Standard of Care for Borderline Resectable, Locally Advanced, and Advanced Pancreatic Adenocarcinoma Patients (PANCAX-3) With Cachexia and Exocrine Pancreatic Insufficiency

Adherence to therapy of at least 50% of the needed total lipase units, recorded using a daily compliance diary.

As measured by Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. The ASA24 is a system to collect 24-hour food recalls and provide complete nutrient analysis of the foods and beverages consumed during the collection timeframe. The tool is used in this study to measure total calories consumed.

As measured by patient reported number of bowel movements in the past 24 hours. In this study, higher numbers represent more severe symptoms; a reduction in number of bowel movements in the past 24 hours represents improvement in symptoms.

As measured by patient reported stool consistency using the Bristol Stool Chart.The Bristol Stool Chart is a diagnostic scale to classify stool into 7 different groups, ranging from Type 1-7 (indicating solid to liquid consistency or time spent longest in the bowel to least time in the bowel). A normal stool should be either Type 3 or Type 4 (middle of the scale). Worsening of stool consistency is denoted by classifications located closer to the extreme ends of the scale (Type 1 or Type 7).

As measured by continuous daily wearable activity monitor

VIVUS LLC

Sponsor-Investigator

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack

Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack

Treatment with standard dose or higher dose Pancrelipase will continue for 20 weeks from enrollment. Participants will consume assigned blinded weight based Pancrelipase dose concurrent with first bite of every meal and snack for the duration of enrollment.

Pertzye

Eileen O'Reilly, MD

Mark Schattner, MD

The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.

Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT).

Memorial Sloan Kettering Cancer Center

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).

Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).

Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units

Placebo Oral Capsule

Massimo Raimondo, MD

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme replacement therapy in weight loss and quality of life.

Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic ultrasound (EUS).

Patients with PEI (FE1 \<200) receive Pertzye or placebo in a cross-over fashion, each for 4 weeks.

Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).

Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.

PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.

Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 4 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).

Quality of life will be measured using the FACT-Hep questionnaire (Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer) for physical, social, emotional, and functional quality of life at the time of accrual, and at 10 weeks of cross-over treatment. The FACT-Hep scale consists of 45 questions, with possible responses ranging from 0 (not at all) to 4 (very much). Therefore, the total score can range from 0 (not at all - no issues) to 180 (very much - very poor quality of life).

Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.

Digestive Care, Inc.

Massimo Raimondo, M.D.

Professor, College of Medicine

Subjects who received placebo oral capsule in either the first or last 4 weeks of the study

Placebo

Subjects who received Pancrelipases oral capsules in either the first or last 4 weeks of the study

Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in first intervention period, and Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in second intervention period (after 2 week washout period).

Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units

Placebo Oral Capsule: Placebo Oral Capsule

Placebo First, Then Pancrelipase

Pancrelipase 3 capsules are taken with or after meals (4800 lipase units) and 2 capsules with or after snacks (3200 lipase units) during 4 weeks in first intervention period, and Placebo oral capsule: 3 capsules taken with or after meals, and 2 capsules taken with or after snacks during 4 weeks in second intervention period (after 2 week washout period).

Pancrelipase: Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units

Placebo Oral Capsule: Placebo Oral Capsule

Pancrelipase First, Then Placebo

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Massimo Raimondo

Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.

Change in Body Weight

Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks

Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks

Change in Body Weight Composition

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Fibrosis

Cystic Fibrosis

Pancreatitis

Pancreatitis, Chronic

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Participants will receive daily dose of CREON.

CREON

ABBVIE INC.

Exocrine pancreatic insufficiency (EPI) is a condition where the pancreas does not have enough pancreatic enzymes to break down food. Some symptoms of EPI are frequent gas/bloating, unexplained stomach pains, frequent diarrhea, and foul-smelling, greasy stools. The purpose of this study is to see how effective CREON is for treating symptoms of EPI due to causes other than cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy (PY), or pancreatic cancer (PC).

CREON (Pancrelipase) is an approved drug used to treat people who cannot digest food normally due to their pancreas not making enough enzymes. Adult participants with a diagnosis of EPI due to causes other than CF, CP, PY, or PC will be enrolled. Around 50 participants will be enrolled in approximately 20 sites in the United States.

Participants will receive oral CREON capsules with each meal and snack beginning at Day 1 for 27 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or a clinic. Participants will need to be confined for 2 separate periods of 6 to 8 days each to measure Co-efficient of Fat Absorption (during screening and after enrollment). The effect of the treatment will be checked by medical assessments, blood and stool tests, checking for side effects and completing questionnaires.

Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer

A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

CFA is calculated as 100\*\[fat intake - stool fat\]/fat intake. Fat intake will be determined from fat content of food consumed on Days 3 to 5 in the confinement period. Stool fat will be determined from the fat content in the stool(s) collected between the two dye markers in the confinement period.

Change in GI symptoms is measured by AbbVie exocrine pancreatic insufficiency (EPI) symptom questionnaire. EPI symptom questionnaire is a 12-item patient-reported outcome (PRO) instrument that assesses EPI symptoms over the past 7 days.

Stool frequency per 24 hours will be recorded daily during the 2 confinement periods. The average stool frequency per 24 hours during confinement period 1 will be considered as baseline.

Stool consistency will be evaluated using the Bristol Stool Scale. The Bristol Stool chart is a medical aid designed to classify feces.

Change from Baseline in vitamin D will be assessed through clinical laboratory testing.

Change from Baseline in vitamin E will be assessed through clinical laboratory testing.

Change from Baseline in vitamin K will be assessed through clinical laboratory testing.

Change from Baseline in vitamin A will be assessed through clinical laboratory testing.

Change from Baseline in retinol-binding protein will be assessed through clinical laboratory testing.

Change from Baseline in albumin will be assessed through clinical laboratory testing.

Change from Baseline in prealbumin will be assessed through clinical laboratory testing.

Change from Baseline in transferrin will be assessed through clinical laboratory testing.

The mean change of weight from Baseline will be calculated.

BMI is a measure of body fat based on weight in relation to height.

Hip circumference is measured by placing the measuring tape around the maximum circumference of the buttocks.

Waist circumference is measured by placing a measuring tape on top of the hip bone and wrapping the tape around the waist.

GIQLI is a 36-item patient reported outcome (PRO) instrument used to assess GI-specific quality of life in participants with GI disorders, with response score ranging from 0 to 4 (0 being "all the time" and 4 being "never").

AbbVie

* Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.
* Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date

Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.

Arthur James Moser, MD

This research study is evaluating a study drug to treat pancreatic exocrine insufficiency (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is recovering from surgery and receiving adjuvant treatment.

The study drug involved in this study is:

-Zenpep

The FDA (the U.S. Food and Drug Administration) has approved Zenpep as a treatment option for PEI. Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.

In this research study, the investigators are studying whether Zenpep will improve the ability of patients to complete adjuvant treatment for their pancreatic cancer after surgery to remove their tumor. The investigators are also studying if Zenpep will have an effect on nutrition status and quality of life for pancreatic cancer patients after they have had surgery to remove their tumor.

Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma

A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma

Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment

Percentage of subjects with resected pancreatic cancer starting adjuvant treatment by postoperative day 84

Pill count performed by study staff to be compared to subject meal and pill diary to determine percent adherence to prescribed regimen

Pill count performed by study staff will be compared to subject meal and pill diary to determine percent adherence to prescribed regimen

Quantify serum albumin (g/dl ) to correlate pancreatic enzyme replacement therapy with nutrition status before and after surgery and adjuvant therapy for early stage pancreatic cancer

Measure body weight (in kg) at regular intervals throughout study participation to investigate whether pancreatic enzyme replacement therapy improves nutrition status during surgery and adjuvant treatment for early stage pancreatic cancer

Subjects to complete EQ-5D-5L at regular intervals throughout study participation. The scale consists of 5 questions, one each to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has answers ranging from No Problems (level 1) to Extreme Problems (level 5). Subjects also to rate their overall health on a given day using the EuroQoL Visual Analog Scale (EQ-VAS) as a part of the EQ-5D-5L, which consists of marking on a visual scale from 0-100 (with 100 being best imaginable health and 0 being worst health imaginable).

Incidence and severity of postoperative complications graded by Clavien-Dindo classification

Standard grip strength dynamometer measurements at regular intervals throughout the study

Allergan

Dana-Farber Cancer Institute

Principal Investigator

The definition of adverse events and/or serious adverse events does not differ from clinicaltrials.gov.

* Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.
* Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date

Pancrelipase: Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.

Zenpep

Age, Categorical

Ethnicity (NIH/OMB)

Participant must be a candidate for standard of care adjuvant treatment according to their treating

Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to company acquisition.

Early termination per sponsor leading to small numbers of subjects enrolled. Those subjects who were enrolled did not meet pathologic criteria to remain on study and would have been replaced had the study continued.

A. James Moser, MD

Patients did not meet pathologic criteria upon surgery. Trial was subsequently terminated by sponsor due to sponsor acquisition.

Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer

Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer

Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count

Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer

Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer

Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer

Evaluate Quality of Life Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer Using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency	NCT04098237	Pancreatic Aden...	Pancrelipase	18 Years -	Cedars-Sinai Medical Center
Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)	NCT05642962	Metastatic Panc... Metastatic Panc... Metastatic Panc... Metastatic Panc... Pancreatic Carc... Pancreatic Carc... Pancreatic Carc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... PDAC PDAC - Pancreat...	Pertzye	18 Years -	Memorial Sloan Kettering Cancer Center
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	NCT02985801	Pancreatic Insu... Pancreatic Canc... Pancreatic Enzy...	Pancrelipase Placebo Oral Ca...	18 Years - 80 Years	Mayo Clinic
Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer	NCT04315311	Exocrine Pancre...	CREON	18 Years -	AbbVie
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	NCT02985801	Pancreatic Insu... Pancreatic Canc... Pancreatic Enzy...	Pancrelipase Placebo Oral Ca...	18 Years - 80 Years	Mayo Clinic
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer	NCT02985801	Pancreatic Insu... Pancreatic Canc... Pancreatic Enzy...	Pancrelipase Placebo Oral Ca...	18 Years - 80 Years	Mayo Clinic
Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma	NCT03469258	Pancreatic Canc...	Pancrelipase	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for pancrelipase

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