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The effects of micellar curcumin (Espera) on the immune function of pancreatic cancer patients.

The effects of micellar curcumin (Espera) on the immune function of pancreatic cancer patients. - Effects of curcumin on the immunesystem in pancreatic cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46507
Enrollment
120
Registered
2018-06-28
Start date
2018-07-22
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer pancreatic ductal adenocarcinoma

Interventions

Investigational treatment consist of oral micellar curcumin (Espera®). Resectable patients will receive 2dd2 capsules (18 mg micellar curcumin/capsule) for a period of at least 2 weeks prior to thei

Sponsors

Stichting Leveronderzoek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age * 18 years. * Diagnosed with resectable or borderline resectable pancreatic cancer (patientgroup 1) OR stable (metastatic)disease after standard of care treatment (patientgroup 2). * An SIII of 900 or higher. * Bilirubin

Exclusion criteria

Exclusion criteria: * Prior radiotherapy, chemotherapy, or resection for pancreatic cancer if included in patientgroup 1. * Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer. * Pregnancy. * Unable to draw blood for study purposes. * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
Determine whether micellar curcumin (Espera®) is able to improve the SIII index in operable PDAC patients OR PDAC patients with stable (metastatic) disease after standard of care treatment.

Secondary

MeasureTime frame
There will be no secondary objective for patient group 1: (borderline) resectable pancreatic cancer patients. For patient group 2: pancreatic cancer patients with stable (metastatic) disease after standard of care we will determine if there is a time-trend in SIII changes by using repeated measurements.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)