Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Disease Progression

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

All Drugs and Chemicals

Vasodilator Agents

Lipid Regulating Agents

Antineoplastic Agents

Hematinics

Vitamins

Niacinamide

Niacin

Nicotinic Acids

Erlotinib Hydrochloride

Gefitinib

Folic Acid

Vitamin B Complex

Trace Elements

Hypolipidemic Agents

Antimetabolites

Nicotinamide

Nicotinic Acid

Vitamin B3

Folate

Vitamin B9

Nicotinamide with EGFR-TKI:

1. gefitinib (250mg tab) or erlotinib (150mg tab) - per oral, once a day
2. nicotinamide (500mg tab) - per oral, twice a day, until the event or censoring occurs

Placebo tablet with EGFR-TKI:

1. gefitinib (250mg tab) or erlotinib (150mg tab) - per oral, once a day
2. placebo tablet - per oral, twice a day, until the event or censoring occurs

Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients

Il Yeong Park, PhD

Nicotinamide is an inhibitor of human sirtuins (HDAC III), and is found to re-activate epigenetically silenced tumor suppressors, RUNX3 (runt-related gene 3) and others, in cancer cells. Nicotinamide was found to be effective in several animal cancer models including lung, bladder, liver, etc. The purpose of this study is to determine whether nicotinamide is also effective in the treatment of human lung cancer.

The standard therapy to the EGFR (epidermal growth factor receptor) mutation positive non-small-cell lung cancer patients who are not eligible to operation is to administer EGFR-TKIs (tyrosine kinase inhibitors, gefitinib or erlotinib). To determine the effectiveness of nicotinamide on lung cancer, nicotinamide or placebo tablet will be co-administered with gefitinib or erlotinib for two years until the event or censoring occurs. The stratified block randomization was designed with 3 covariates (EGFR mutation status, kind of EGFR-TKI, ECOG (Eastern Cooperative Oncology Group) performance status score variation). The size of lesions will be checked every other months by radiology. PD (progressive disease) will be assessed according to RECIST(Response Evaluation Criteria in Solid Tumors)1.1. After observing 36 events, an interim analysis of hazard ratio by Cox proportional hazard regression will be performed. The final analysis will be done by the same protocol after observation of 72 events. The significance level of the interim and final analysis were set to 0.0075 and 0.0209 respectively. Response rate, quality of life (measured by 10 questions at every visit), and overall survival will be analysed together. All other adverse reactions will be analysed and reported, if there.

Anticancer Activity of Nicotinamide on Lung Cancer

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

chi-square test of complete response and partial response (RECIST 1.1)

measured by the cancer-related QOL questionaire response (questioned at each visit)

Il Yeong Park, Ph.D.

Professor

Skin and Connective Tissue Diseases

Skin Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Oral nicotinamide (500 mg) twice daily for at least 52 weeks

Matching placebo taken twice daily for at least 52 weeks

Placebo oral capsule

An-Wen Chan, MD DPhil

Joseph Kim, MD PhD

A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.

Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial

If feasibility thresholds are met, this pilot trial will proceed to a larger pivotal trial. The study protocol for the pivotal trial will be published prior to completion of data collection. Beyond 2 years after completion of the pivotal trial, the cleaned, anonymized, participant-level dataset and statistical code will made available for sharing with external researchers upon approval of a study proposal describing the intended data usage.

Proportion of patients who consent to data linkage to provincial administrative databases

Reasons for exclusion of screened patients

Proportion of capsules returned, reasons for non-adherence

Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation

Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.

Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 1 week. An increased level will be classified as clinically relevant if the transplant physician reduces the immunosuppressant dose in response to the increased drug level.

Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 2 weeks. This measurement will be dropped if all cases of clinically relevant drug interactions manifest at 1 week in the first 20 enrolled participants.

Descriptive tabulation (preliminary safety)

Proportion of enrolled participants who consent to participate in the neurocognitive substudy

Montreal Cognitive Assessment (MoCA) score \<26, scored out of 30.

Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function

Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory

Trail Making A and B, a visual attention test. This records the time (in seconds) to completion, with a faster time representing better cognitive function

Controlled Oral Word Association, a verbal fluency test, measures the production of words belonging to the same letter. This records total number of words produced, with a higher number representing better verbal fluency.

Animal Naming Task, a verbal fluency task, measures the total number of animals named in one minute, with a higher number representing better verbal fluency

Wechsler Adult Intelligence Scale - Revised, Digit Span subtest, a number sequencing memory test, measures the number of correctly repeated sequences with maximum score of 48. The higher score represents better cognitive function

Canadian Institutes of Health Research (CIHR)

The Kidney Foundation of Canada

NOW Foods

Natural Life Nutrition

Women's College Hospital

Vitamin A

Retinol palmitate

Retinol

1,000 μg retinyl palmitate and 500 mg NAM twice a day

1,000 μg retinyl palmitate twice a day for 6 months

Other: Placebo

Eunyoung Cho, ScD

The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 \[niacin\]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.

Pilot Trial of Supplemental Vitamin A and Nicotinamide

Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide

Rhode Island Hospital

Eye Diseases

Heart and Blood Diseases

Rare Diseases

Ganglion Cysts

Glaucoma

Synovial Cyst

Cysts

Hypertension

Ocular Hypertension

Mucinoses

Connective Tissue Diseases

Oculocerebral Syndrome With Hypopigmentation

Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID)

Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID)

Nicotinamide(Mitovita)

Placebo

Seungsoo Rho, MD, PhD

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study

Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients

Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 12 weeks

Change of PhNR_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks

Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks

Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation

Change of visual field sensitivity number of locations in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total, pattern deviation

Hanlim Pharm. Co., Ltd.

CHA University

Blood and Lymph Conditions

Immune System Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies.

oral nicotinamide 500 mg twice daily (BID)

oral placebo twice daily for first year. Cross over to oral nicotinamide 500 mg twice daily (BID) for year two.

Lindsey Gilstrap

Catherine Cromar

Lindsey Fitzgerald, MD

This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year.

Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies.

Enrollment will be split into two parts separated by an interim analysis. Part 1 will accrue 40 patients: 20 to each arm. After 40 patients have completed their 12 month visit an interim futility analysis will be conducted prior to recruiting more patients. The study will stop if the difference in the number of patients with NMSC between control and treatment arms is 0 or less (i.e., absolutely no evidence that the treatment is better than control). If the trial is not stopped, the investigators will proceed with Part 2 and recruit 46 more patients.

Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)

Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)

evaluate whether nicotinamide can reduce the number of patients who develop one or more new NMSC versus placebo in CLL patients with a history of NMSC.

assess the effect of oral nicotinamide on the number of new NMSC in patients with CLL who have previously been diagnosed with a NMSC.

assess whether nicotinamide can reduce the number of patients who develop a SCC versus placebo in CLL patients with a history of NMSC.

assess whether nicotinamide can reduce the number of subjects who develop a BCC versus placebo in CLL patients with a history of NMSC

evaluate whether nicotinamide can reduce the number of subjects who develop AK versus placebo in CLL patients with a history of NMSC

evaluate whether nicotinamide can reduce the number of recurrent NMSC in the same patient between year 1 on placebo therapy and year 2 on nicotinamide therapy

2.2.6 To compare objective response rates (CR + PR) and CR rates between patients not on active CLL therapy who receive nicotinamide versus placebo

2.2.7 To compare overall response rates (CR+ partial PR) and CR rates between patients not on active CLL therapy with and without mutations with DNA mismatch repair who receive nicotinamide versus placebo

evaluate the safety and tolerability of each arm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anticancer Activity of Nicotinamide on Lung Cancer	NCT02416739	Non-Small-Cell ...	Nicotinamide	18 Years -	Chungbuk National University
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial	NCT03769285	Non-melanoma Sk... Carcinoma, Squa... Carcinoma, Basa...	Nicotinamide Placebo oral ca...	18 Years -	Women's College Hospital
Pilot Trial of Supplemental Vitamin A and Nicotinamide	NCT05702398	Skin Cancer Kidney Transpla...	Vitamin A Nicotinamide Other: Placebo	18 Years -	Rhode Island Hospital
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients	NCT06078605	Glaucoma	Nicotinamide(Mi... Placebo	19 Years -	CHA University
Anticancer Activity of Nicotinamide on Lung Cancer	NCT02416739	Non-Small-Cell ...	Nicotinamide	18 Years -	Chungbuk National University
Anticancer Activity of Nicotinamide on Lung Cancer	NCT02416739	Non-Small-Cell ...	Nicotinamide	18 Years -	Chungbuk National University
Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)	NCT04844528	Chronic Lymphoc...	Nicotinamide Placebo	18 Years -	University of Utah
Pilot Trial of Supplemental Vitamin A and Nicotinamide	NCT05702398	Skin Cancer Kidney Transpla...	Vitamin A Nicotinamide Other: Placebo	18 Years -	Rhode Island Hospital
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients	NCT06078605	Glaucoma	Nicotinamide(Mi... Placebo	19 Years -	CHA University

Spots Global Cancer Trial Database for nicotinamide

Every month we try and update this database with for nicotinamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.