Determine whether micellar curcumin (Espera®) is able to improve the Systemic Immune Inflammation index in operable PDAC patients OR (metastasized) pancreatic cancer patients with stable disease after standard of care treatment.
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Patients diagnosed with pancreatic cancer have a poor survival. The presence of
pancreatic cancer is known to affect the functionality of the immune system. In
addition to the common factors affecting the prognosis of cancer patients,
individual differences in immune factors among patients also affect prognosis.
The majority of tumors have an inflammatory component which can either promote
cancer growth, e.g., *cancer related inflammation* or inhibit cancer
progression, e.g., *cancer immune surveillance*. The systemic inflammation
immune index (SIII) represents systemic inflammatory responses and can be used
to indicate the host inflammatory and immune status in resected cancer
patients. In this study we would like to investigate whether we are able to
improve the SIII of PDAC patients by prescribing the oral food supplement
curcumin. Curcumin can modulate the immune system of pancreatic cancer patients
by restoring the functional lymphocytes (T cell populations) and skewing the
immune response from an unfavorable to a favorable immune response. This
increased population of functional T cells will lead to a decrease in the SIII,
which in turn is associated with a more favorable disease outcome.
Study objective
Determine whether micellar curcumin (Espera®) is able to improve the Systemic
Immune Inflammation index in operable PDAC patients OR (metastasized)
pancreatic cancer patients with stable disease after standard of care
treatment.
Study design
Exploratory single centre, randomized, open label study.
Intervention
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 their surgical
resection. The control group will not undergo any intervention.
Patients with stable disease will receive 2dd2 capsules (18 mg micellar
curcumin/capsule) for a period of 4 weeks. Patients will continue to receive
oral micellar curcumin (Espera®) during 12 week periods until no further
benefit can be determined (defined as SIII >900, SIII >900 and no significant
decrease (<20%) or disease recurrence/disease progression on imaging). In
addition these patients will undergo additional blood sampling.
The control group will not receive curcumin treatment but will undergo 3
additional blood samplings during a 12 week period.
Study burden and risks
Resectable patients will undergo no additional blood sampling procedures
compared to their standard of care. Patients with stable (metastatic)disease
will undergo an additional blood sampling procedure after every 4 weeks of
treatment.
Patient safety is assessed during the study. At each visit patients are checked
for adverse events and vital signs. In addition, regular CT scans will be
performed during standard of care to keep track of tumor characteristics during
the treatment period, however no additional CT scans will be performed. Any
remaining risks are deemed acceptable since the treatment options for these
patient groups are limited and overall survival is usually only a year after
diagnosis.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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 <35 µmol/L(after drainage if applicable).
* Planned surgical treatment (patientgroup 1) OR completed standard of care treatment (patientgroup 2).
* Signed informed consent.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64789.078.18 |