Anticancer Activity of Nicotinamide on Lung Cancer
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ClinicalTrials.gov Identifier: NCT02416739 |
Recruitment Status : Unknown
Verified January 2020 by Il Yeong Park, Ph.D., Chungbuk National University.
Recruitment status was: Active, not recruiting
First Posted : April 15, 2015
Last Update Posted : January 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Non-Small-Cell Lung Carcinoma | Drug: Nicotinamide | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Double-blinded Comparative Trial to Study the Add-on Activity of Combination Treatment of Nicotinamide on Progression Free Survival for EGFR Mutated Lung Cancer Terminal Stage Patients Being Treated With Gefitinib or Erlotinib |
Actual Study Start Date : | March 2015 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Nicotinamide
Nicotinamide with EGFR-TKI:
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Drug: Nicotinamide
Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients
Other Name: Amina-X |
Placebo Comparator: Placebo
Placebo tablet with EGFR-TKI:
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Drug: Nicotinamide
Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients
Other Name: Amina-X |
- Hazard ratio (PFS) of the nicotinamide arm to the placebo arm [ Time Frame: two year ]Cox regression analysis
- Response rate [ Time Frame: two year ]chi-square test of complete response and partial response (RECIST 1.1)
- Difference in quality of life between the nicotinamide arm and the placebo arm [ Time Frame: two year ]measured by the cancer-related QOL questionaire response (questioned at each visit)
- Overall survival [ Time Frame: two year ]Cox regression analysis

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Operation-impossible stage 4 non-small-cell lung carcinoma (NSCLC), or recurred terminal stage NSCLC after previous operation or radiation therapy
- EGFR mutated (exon 19 deletion or L858R mutation)
- Life expectation more than 3 months
- More than 1 measurable lesions by RECIST 1.1 which were not exposed to radiation previously
- ECOG (Eastern Cooperative Oncology Group ) performance status grade 0~2
- Who signed the informed consent form
Exclusion Criteria:
- Who had received chemotherapy or EGFR tyrosin kinase inhibitors previously, except whom had received operation at least 6 months ago and received supplementary chemotherapy
- Who has metastasized brain lesion that needs operation or radiation therapy
- Above grade 2, CTCAE (Common Toxicity Criteria for Adverse Effects) 4.0 criteria for blood, liver and kidney
- Who does Not agree to contraception
- Who has allergy to nicotinamide

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416739
Korea, Republic of | |
Chonnam National University Hwasun Hospital | |
Hwasun, Chonnam, Korea, Republic of, 58128 |
Study Director: | Il Yeong Park, PhD | Chungbuk National University |
Responsible Party: | Il Yeong Park, Ph.D., Professor, Chungbuk National University |
ClinicalTrials.gov Identifier: | NCT02416739 |
Other Study ID Numbers: |
Amina-X-002 |
First Posted: | April 15, 2015 Key Record Dates |
Last Update Posted: | January 27, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
EGFR mutated lung cancer |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Niacinamide |
Niacin Nicotinic Acids Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |