To determine whether micellar curcumin is able to restore functional lymphocytes in 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
To determine whether micellar curcumin (Espera C®) is able to skew the T-cell
subsets of PDAC patients with stable disease after standard of care treatment.
Additionally, we will determine whether curcumin*s effects on the immune status
is reflected by improvement in the SIII and the differences in
immunology-related gene expression and cell types between PDAC patients.
Secondary outcome
To determine whether curcumin*s effects on the immune status is reflected by
improvement in the SIII and the differences in immunology-related gene
expression and cell types between PDAC patients.
Background summary
Patients diagnosed with pancreatic cancer have a very poor survival rate. The
recognition of cancer inflammation as an important hallmark of cancer, as well
as the recognition of the important role of the immune system in cancer
surveillance and elimination, has led to the examination of various
inflammatory markers as prognostic factors in cancer. Pancreatic cancer is
characterised by tumor-mediated immune suppression and an imbalance in immune
cells favouring the subsets that are associated to a poor prognosis (high
T-regulatory, low cytotoxic lymphocytes). The systemic inflammation immune
index (SIII) represents systemic inflammatory responses and can be used to
indicated the host inflammatory and immune status in pancreatic cancer
patients. Recently, we found that the SIII is an independent predictor of both
cancer-specific survival and recurrence in patients with resectable pancreatic
ductal adenocarcinoma (PDAC).
The oral food supplement curcumin has been deemed as a potent, pleiotropic
anti-inflammatory drug that can modulate the immune system. In pancreatic
cancer patients, curcumin could restore functional lymphocytes (T cell
populations) and skew the immune response from an unfavourable to a favourable
one.
Study objective
To determine whether micellar curcumin is able to restore functional
lymphocytes in pancreatic cancer patients with stable disease after standard of
care treatment.
Study design
Single center, prospective, open label study. PDAC patients with stable disease
after standard of care treatment will be eligible to participate in this study.
Participants currently on over the counter curcumin will be asked to stop
treatment for at least 2 weeks in order to wash out any curcumin from their
system which could interfere with our measurements. During the study, blood
samples will be drawn at 2 sampling points: baseline (after 2 weeks wash out if
applicable) and after 6 weeks of Espera C® treatment. Each blood sample
consists of 1 x 10 ml EDTA blood and 1 x 3 ml Tempus blood. The Tempus blood
will be used to isolate RNA in order to conduct immune profiling using
multiplex gene expression with NanoString.
Intervention
Investigational treatment consists of oral micellar curcumin (Espera C®).
Patients will receive 2dd2 capsules (18 mg micellar curcumin/capsule) for a
period of 6 weeks. Patients will undergo blood sampling at baseline and after 6
weeks of oral micellar curcumin (Espera®).
Study burden and risks
Patients with stable disease will undergo two additional blood sampling
moments. The baseline is drawn during a standard of care visit) and the second
sample is drawn after 6 weeks of oral micellar curcumin (Espera C®).
Curcumin is a safe product with little to no side effects, so the risks
associated with participation are limited. In PDAC patients possible side
effects are deemed acceptable due to the very limited number of possible
treatment options and short overall survival which is usually only a year after
diagnosis. If side effects become too debilitating, dose reduction can be
considered or the patient can be withdrawn from study.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
* Age between 18 and 65 years.
* Diagnosed with stable pancreatic cancer after standard of care treatment
(defined as no detectable disease recurrence or disease progression on CT
imaging within 6 weeks after completing standard of care treatment.
* Completed standard of care treatment.
* Bilirubin < 35 µmol/L (after drainage if applicable).
* Patient should be able to understand the content of the protocol and be able
to perform all follow ups.
* Signed informed consent.
Exclusion criteria
* 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 participant or their ability to complete the study, at the discretion of
the investigator.
* Surgery, or other procedures (other than the pancreatic surgery) that have
altered the gastrointestinal integrity which might influence uptake op Espera
C®.
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 | NL71487.078.19 |