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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
20
80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability
250 mg PO daily until progression
150 mg PO daily until progression
Peter Brojge Lung Cancer Center, Jewish General Hospital
Montreal, Quebec, Canada
RECRUITINGfeasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
Feasibility will determine whether the use of curcumin is appropriate for further testing; and will be assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
Time frame: 8 weeks
feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits
will by assessed by follow-up rate= number of actual study visits/ total number of study visits
Time frame: 8 weeks
feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules
Adherence/Compliance rate= Number of taken capsules/Total number of capsules
Time frame: 8 weeks
feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires
Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires
Time frame: 8 weeks
safety number of side effects
Safety will be assessed by number of side effects
Time frame: 16 weeks
To evaluate and compare the changes in health-related quality of life before and after
Patients' quality of life on curcumin treatment will be assessed by the FACT-L at the baseline, 4 weeks,8 weeks on concurrent curcumin and TKI and 8 weeks post-study. Clinically important difference in the score is considered 2 points.
Time frame: 8 weeks
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To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein)
anti-inflammatory effects of curcumin will be assessed by measuring C-reactive protein tests will be performed at baseline, 2, 4, 8 and 16 weeks into study.
Time frame: 8 weeks