A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC
- Conditions
- Lung Cancer
- Interventions
- Dietary Supplement: CurcuVIVA™
- Registration Number
- NCT02321293
- Lead Sponsor
- Lady Davis Institute
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 CurcuVIVA™ CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy. CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin) Tyrosine Kinase Inhibitors: 1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg . 2. Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg . Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin. 1 Tyrosine Kinase Inhibitor erlotinib (Tarceva) CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy. CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin) Tyrosine Kinase Inhibitors: 1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg . 2. Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg . Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin. 1 Tyrosine Kinase Inhibitor gefitinib (Iressa) CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy. CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin) Tyrosine Kinase Inhibitors: 1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg . 2. Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg . Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.
- Primary Outcome Measures
Name Time Method 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 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 Adherence/Compliance rate= Number of taken capsules/Total number of capsules 8 weeks Adherence/Compliance rate= Number of taken capsules/Total number of capsules
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
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Peter Brojge Lung Cancer Center, Jewish General Hospital
🇨🇦Montreal, Quebec, Canada