Active — Not RecruitingPhase 2

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

United States36 participantsStarted 2020-12-17

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Borderline resectable, locally advanced, and advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC (Samuel Oschin Cancer Center - Cedars Sinai Medical Center)
✓. Age ≥ 18 years.
✓. ECOG performance status 0-1 or Karnofsky PS \>60%
✓. Clinical diagnosis of exocrine pancreatic insufficiency
✓. Cachexia defined as at least 5% weight loss in the presence of chronic illness, within any 6-month period prior to screening OR as documented by the medical physician based on standard diagnosis of cachexia
✓. Life expectancy of greater than 3 months, in the opinion of the investigator.
✓. Patients must have normal organ and marrow function as defined below:
✓. Woman of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of signing the informed consent form, for the duration of study participation, and for at least 30 days after discontinuing from study treatment.

Exclusion criteria

What they're measuring

Feasibility of Completing Pancreatic Enzyme Replacement Therapy During the First 8 Weeks of the Study: Daily Compliance Diary

Timeframe: 8 weeks

Trial details

NCT IDNCT04098237

SponsorAndrew Hendifar, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-12

Results submitted2024-12-11

View on ClinicalTrials.gov More Pancreatic Adenocarcinoma trials