Clinical trial NCT02321293: A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC
Official title: A Phase 1 Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors for Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lung Cancer
Keywords: curcumin
lung cancer
TKI
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
First posted: 2014-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is is to assess the safety and tolerability of curcumin in combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR NSCLC.

Detailed description: This is a phase 1 open prospective cohort study to assess the safety and feasibility of using curcumin in conjunction with an EGFR-TKI in patients with advanced NSCLC. The investigators will use an enhanced bioavailable formulation of curcumin (CURCUViva TM at 80 mg/ 1 capsule per day) approved and licensed by Health Canada (NPN 80027414) that has been shown to have 2-3 times higher curcumin concentration in the blood as compared to previous clinical trials. As primary objective, the investigators will recruit 20 patients for a duration of 8 weeks to monitor adverse effects according to the the National Cancer Institute Common Terminology Criteria.Exploratory objectives would include assessing changes in health-related quality of life using the standardized FACT-L questionnaire and evaluating anti-inflammatory properties of curcumin by measuring CRP. If tolerable safety data is obtained, an expanded phase II trial will be designed.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage 4.
* The EGFR mutation analysis must be performed prior to enrolment into the trial (i.e., before a patient is consented). Any EGFR mutation-positive result must be documented and the analysis for the mutation will be performed using the JGH local testing methodology.
* Receiving concurrent EGFR-TKI therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Score 0-3

Exclusion Criteria:

* Symptomatic brain metastases.
* Patients who are receiving any other investigational agents.
* Patients using other non-vitamin or mineral regular natural health product, which includes Chinese Herbs.
* Incapacity to understand and sign a written informed consent document in English/French.
* Pregnancy

Primary outcomes:
measure: feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
timeFrame: 8 weeks
measure: feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits
timeFrame: 8 weeks
measure: feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules
timeFrame: 8 weeks
measure: feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires
timeFrame: 8 weeks
measure: safety number of side effects
timeFrame: 16 weeks
Secondary outcomes:
measure: To evaluate and compare the changes in health-related quality of life before and after
timeFrame: 8 weeks
measure: To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Peter Brojge Lung Cancer Center, Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute
name: Victor Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: