Pancreatic Cancer, Pancreatic Enzyme Abnormality, Pancreatic Insufficiency
Conditions
Brief summary
Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?
Detailed description
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.
Interventions
DRUGPancrelipase
Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
DRUGPlacebo Oral Capsule
Placebo Oral Capsule
Sponsors
Digestive Care, Inc.
Massimo Raimondo, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18-80 years * Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis) * On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study * Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool
Exclusion criteria
* Common bile duct obstruction resulting in obstructive jaundice * Celiac disease * Crohn's disease * Benign pancreatic conditions * Bowel obstruction * Surgically altered bowel anatomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, 4 weeks, 10 weeks | Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks | Baseline, 4 weeks | 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). |
| Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks | Baseline, 10 weeks | 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). |
| Change in Body Weight Composition | Baseline, 4 weeks, 10 weeks | Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo First, Then Pancrelipase 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 | 8 |
| Pancrelipase First, Then Placebo 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 | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Placebo First, Then Pancrelipase | Total | Pancrelipase First, Then Placebo |
|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 7.6 | 65.2 years STANDARD_DEVIATION 9.4 | 68.3 years STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Change in Body Weight
Body weight will be measured at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
Time frame: Baseline, 4 weeks, 10 weeks
Population: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Secondary
Change in Body Weight Composition
Body weight composition will be determined at the time of accrual, and at 4 and 10 weeks of cross-over treatment.
Time frame: Baseline, 4 weeks, 10 weeks
Population: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Secondary
Change in Quality of Life Score as Measured by FACT-Hep Scale at 10 Weeks
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).
Time frame: Baseline, 10 weeks
Population: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.
Secondary
Change in Quality of Life Score as Measured by FACT-Hep Scale at 4 Weeks
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).
Time frame: Baseline, 4 weeks
Population: Study was terminated due to difficulty in recruiting subjects. Data was not collected or analyzed.