Lung Cancer
Conditions
Keywords
curcumin, lung cancer, TKI
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.
Interventions
DIETARY_SUPPLEMENTCurcuVIVA™
80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability
DRUGTyrosine Kinase Inhibitor gefitinib (Iressa)
250 mg PO daily until progression
DRUGTyrosine Kinase Inhibitor erlotinib (Tarceva)
150 mg PO daily until progression
Sponsors
Jewish General Hospital
Lady Davis Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits | 8 weeks | will by assessed by follow-up rate= number of actual study visits/ total number of study visits |
| feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires | 8 weeks | Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires |
| safety number of side effects | 16 weeks | Safety will be assessed by number of side effects |
| feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients, | 8 weeks | 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, |
| feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules | 8 weeks | Adherence/Compliance rate= Number of taken capsules/Total number of capsules |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein) | 8 weeks | 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. |
| To evaluate and compare the changes in health-related quality of life before and after | 8 weeks | 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. |
Countries
Canada
Contacts
Primary ContactVictor Cohen, MD
Backup ContactGoulnar Kasymjanova, MD
Outcome results
None listed