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Vitamin
Nicotinamide for Chronic Lymphocytic Leukemia and Skin Cancer
Phase 2
Recruiting
Led By Lindsey Fitzgerald, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria
Adequate liver function as defined as: Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is a study to see if a drug can prevent a type of skin cancer in people with a certain type of blood cancer.
Who is the study for?
This trial is for adults over 18 with Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia who've had non-melanoma skin cancer in the last 5 years. They must have normal liver function, agree to use contraception if of childbearing potential, and not be on certain medications or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests whether Nicotinamide (a form of vitamin B3) taken orally can prevent new non-melanoma skin cancers in CLL patients. Participants are randomly given either Nicotinamide or a placebo for one year, then all receive Nicotinamide for another year while their skin health is monitored.See study design
What are the potential side effects?
Potential side effects from taking Nicotinamide may include digestive upset like nausea or vomiting, flushing of the skin due to dilation of blood vessels, dizziness and itching. However, individual reactions can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL or SLL according to the latest criteria.
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My liver is functioning well, with normal bilirubin levels.
Select...
I am 18 years old or older.
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I am not pregnant or I am post-menopausal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chronic Lymphocytic Leukemia
Secondary outcome measures
Number of new NMSC on skin exam after 1 year of treatment
frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0 and iwCLL), seriousness, duration, and relationship to study treatment
number of new NMSC developed during year 1 and year 2 for patients who receive placebo during the first year
+5 moreSide effects data
From 2022 Phase 2 trial • 46 Patients • NCT0306147425%
Diarrhoea
17%
Fall
17%
Urinary tract infection
8%
Constipation
8%
Vomiting
8%
Anxiety
8%
Back pain
8%
Laboratory test abnormal
4%
Transaminases increased
4%
Head Injury
4%
Colorectal cancer
4%
Dyspepsia
4%
Upper respiratory tract infection
4%
Arthralgia
4%
Headache
4%
Neuropathy peripheral
4%
Rash
4%
Fungal infection
4%
Penile ulceration
4%
Syncoper
4%
Foot fracture
4%
Osteoporosis
4%
Tooth abscess
4%
Agitation
4%
Weight decreased
4%
Blood testosterone decreased
4%
Hiatus hernia
4%
Glomerular Ffiltration rate decreased
4%
Miliaria
4%
Urticaria
4%
Pleocytosis
4%
Actinic keratosis
4%
Viral upper respiratory tract infection
4%
Thrombocytopenia
4%
Hyperlipidaemia
4%
Laceration
4%
Limb injury
4%
Post lumbar puncture syndrome
4%
Parkinson's disease
4%
Pneumonia
4%
Diabetes mellitus
4%
Myalgia
4%
Colitis ulcerative
4%
Infection
4%
Coccydynia
4%
Cognitive disorder
4%
Renal cyst
4%
Dehydration
4%
Tremor
4%
Cancer surgery
4%
Vitamin D deficiency
4%
Foot deformity
4%
Hypokalaemia
4%
Psoriasis
4%
Dizziness
4%
Dysgeusia
4%
Basal cell carcinoma
4%
Eructation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nicotinamide
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment: all patientsExperimental Treatment1 Intervention
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.
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide
2021
Completed Phase 3
~2810
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,603 Total Patients Enrolled
Lindsey Fitzgerald, MDPrincipal InvestigatorHuntsman Cancer Institute
Deborah Stephens, DOPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken acitretin or other oral retinoids in the last 6 months.You are not expected to live for more than 2 years.I need to keep taking carbamazepine.I have had at least one non-melanoma skin cancer in the past 5 years.I have or had a peptic ulcer.I have an ongoing infection that isn't under control.I have severe digestive issues that affect how my body absorbs medication.I have not had skin treatments for AKs in the last 4 weeks.I am not pregnant or I am post-menopausal.My skin cancer covers large areas, making it hard to count new cancers.My diabetes is not under control.I have been diagnosed with CLL or SLL according to the latest criteria.My liver is functioning well, with normal bilirubin levels.I have stopped taking certain medications as required before starting treatment.I have had chemotherapy with specific drugs in the last 6 months.I have taken nicotinamide or niacin supplements in the last 4 weeks.You have had a severe allergic reaction to the study drug or any of its parts in the past.I agree to use effective birth control during the study.I had a stem cell transplant from a donor within the last 6 months.You have a liver condition called Gilbert's Syndrome with specific levels of bilirubin in your blood.I have had an organ transplant and am on immunosuppressive drugs.I am 18 years old or older.I have HIV with a detectable viral load in the last 6 months.Your liver enzymes (AST and ALT) should be less than 3 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Placebo
- Group 2: Treatment: all patients
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can the potential risk-to-benefit ratio be gauged for Nicotinamide use?
"Assessing safety, Nicotinamide was deemed to be a 2 on our rating scale due to the fact it is currently undergoing Phase 2 clinical trials. This indicates that while there are some data demonstrating its security, no evidence has been found yet supporting its efficacy."
Answered by AI
In what conditions is Nicotinamide typically utilized?
"Nicotinamide is typically employed to help supplement a patient's nutrition. It can also be useful in treating dietary and nutritional therapies, vitamin deficiency, and macrocytic anemia."
Answered by AI
What is the upper limit of individuals being studied in this experiment?
"Indeed, the clinicaltrials.gov website states that this investigation is currently enrolling individuals. The trial was announced on August 5th 2021 and most recently updated January 14th 2022 with 86 participants necessary at one site."
Answered by AI
Are there any vacancies available in this trial for participants?
"As of the time of this writing, patients are being invited to take part in the trial. The protocol was initially posted on August 5th 2021 and amended as recently as January 14th 2022."
Answered by AI
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