Eye Diseases

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Night Blindness

Vitamin A Deficiency

Leukoplakia

Blindness

Precancerous Conditions

Pathological Conditions, Anatomical

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Vision Disorders

Keratomalacia

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Retinol

Biopsy-confirmed diagnosis of hyperkeratosis with dysplasia.

Biopsy-confirmed diagnosis of hyperkeratosis with no dysplasia.

Laryngoscopy showing no evidence of vocal fold mucosal disease.

Nathan Welham, PhD, CCC-SLP

This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.

The investigator's overarching goal is to determine if there is a pathophysiologic rationale for vitamin A supplementation in the treatment of vocal fold hyperkeratosis. Vocal fold hyperkeratosis is an accumulation of epithelial surface keratin resulting in clinical leukoplakia. It is primarily managed using destructive techniques that risk iatrogenic injury, fibrosis, and voice impairment. Given the potential morbidity of biopsy and lesion removal, there is a need for new approaches to the prevention and treatment of vocal fold leukoplakic disorders that are non-destructive. Vitamin A is a key regulator of epithelial health and systemic vitamin A deficiency could directly contribute to hyperkeratosis. Based on vitamin A's importance to vocal fold stellate and epithelial cell biology and its direct relevance to vocal fold hyperkeratosis, this study will assess vitamin A status in participants with vocal fold hyperkeratosis. An association would suggest further study on the effects of vitamin A optimization and/or supplementation in patients with leukoplakia, as well as an adjuvant therapy in participants for whom surgical treatment is indicated.

Vitamin A Status in Patients With Vocal Fold Leukoplakia

Total vitamin A liver concentration determined using retinol stable isotope dilution (μmol/g)

Serum retinyl esters concentration (μmol/L)

Serum carotenoid concentrations (μmol/L)

National Institute on Deafness and Other Communication Disorders (NIDCD)

University of Wisconsin, Madison

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

Vasodilator Agents

Lipid Regulating Agents

Hematinics

Niacinamide

Niacin

Nicotinic Acids

Vitamin B Complex

Trace Elements

Folic Acid

Nicotinamide

Nicotinic Acid

Vitamin B3

Folate

Vitamin B9

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

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

●The dose-limiting toxicity (DLT) assessment period will be set at 4 weeks. After the DLT evaluation period, if no disease progression is observed based on RECIST v1.1, or no unacceptable toxicities are observed in the patient, the investigational drug will be administered orally twice a day after breakfast and dinner for up to 6 courses for each dosage group. However, for the modified dosage level 2 of the Phase I trial, the investigational drug will be administered orally twice a day after breakfast and dinner, starting from the first day (Day 1) of each course, and drug administration will be paused starting from the Day 15 GEM/nab-PTX administration. Furthermore, dose reduction or increase of the investigational drug will not be performed on the same subject.

Level 1: 6 mg (3 capsules). Level 2 \& Modified Level 2: 8 mg (4 capsules). Level 0: 4 mg (2 capsules) if DLT seen in \>33% of Level 1.

●(Phase I / II study) GEM (1000mg/m2) and nab-PTX (125mg/m2) are given intravenously.

The investigational drug at the clinically recommended dose determined in the Phase I trial will be administered orally twice a day after breakfast and dinner, starting from the first day (Day 1) of each course, and drug administration will be paused starting from the Day 15 GEM/nab-PTX administration. This will continue for up to 6 courses. Furthermore, dose reduction or increase of the investigational drug will not be performed on the same subject.

Am80

Administered intravenously at a dose of 1000mg/m2

Administered intravenously at a dose of 125mg/m2

nab-Paclitaxel

Yasuyuki Mizutani

Toshihisa Tsuruta

Tsuruta Toshihisa

Ｋensaku Ｎoguchi

Hiroki Kawashima

Mitsuhiro Fujishiro

To evaluate the safety and tolerability of Am80（Generic name: Tamibarotene, Development code: MIKE-1） in combination with gemcitabine (GEM) and nab-paclitaxel (nab-PTX) in patients with unresectable pancreatic cancer and to determine the recommended dose. Efficacy will also be exploratively investigated.

Cancer-associated fibroblasts (CAFs) are an important component of the tumor microenvironment. The most common notion in the CAF research field has been that CAFs promote cancer progression through various mechanisms. Interestingly, however, recent studies have revealed that CAFs are heterogeneous and that CAF subsets that suppress cancer progression (cancer-restraining CAFs \[rCAFs\]) must exist in addition to well-characterized cancer-promoting CAFs (pCAFs). However, the identity and specific markers of rCAFs have not been reported.

The investigators recently identified Meflin as a specific marker protein of rCAFs in pancreatic and colon cancers. The investigator's studies revealed that rCAFs are similar to a small subset of resident fibroblasts, which is consistent with the famous hypothesis proposed by Micheal Stoker (University of Glasgow) more than 50 years ago, stating that static normal fibroblasts suppress tumor growth. Interestingly, The investigator's lineage tracing experiments showed that Meflin-positive rCAFs differentiate into Meflin-negative pCAFs during cancer progression. These studies revealed that the tumor stroma is comprised of pCAFs and rCAFs, which is analogous to the heterogeneity of tumor-infiltrating immune cells (e.g., protumor regulatory T cells versus antitumor cytotoxic T cells).

The identification of the rCAF marker Meflin enabled the investigators to develop new strategies to convert or reprogram pCAFs to rCAFs. Using a pharmacological approach, The investigators performed a chemical library screen and identified Am80, a synthetic unnatural retinoid, as a reagent that effectively converts Meflin-negative pCAFs to Meflin-positive rCAFs. Am80 administration improved the sensitivity of pancreatic cancer to chemotherapeutics. These data suggested that the conversion of pCAF to rCAFs may represent a new strategy for pancreatic cancer treatment.

The object of this study is to perform an investigator-initiated clinical study to investigate the effect of AM80 on pancreatic cancer with a combination of conventional tumoricidal agents including gemcitabine and nab-paclitaxel.

Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies.

Investigator-initiated Clinical Trial of MIKE-1

Phase I/II Investigator-initiated Clinical Trial of MIKE-1 With Gemcitabine and Nab-paclitaxel Combination Therapy for Unresectable Pancreatic Cancer

The severity of adverse events will be determined by the investigator based on CTCAE v 5.0.

* Grade 4 hematologic toxicity that persists for more than 7 days
* Grade 3 or higher non-hematologic toxicity that persists for more than 7 days despite symptomatic treatment
* An adverse event that caused the inability to administer both Day 8 and Day 15 of Cycle 1 of GEM or nab-PTX
* An adverse event that caused the inability to administer Day 8 of the first cycle of GEM or nab-PTX, resulting in a reduced dose of Day 15

If each subject has measurable disease, tumor shrinkage efficacy determination (CR, PR, SD, PD, NE) will be performed based on RECIST v1.1.

Adverse events will be classified and tabulated in MedDRA/J.

The distribution of overall survival will be estimated by the Kaplan-Meier method, the Kaplan-Meier curve will be illustrated, and the median and 95% confidence interval will be calculated.

The distribution of progression-free survival will be estimated by the Kaplan-Meier method, the Kaplan-Meier curve will be illustrated, and the median and 95% confidence interval will be calculated.

Japan Agency for Medical Research and Development

Nagoya University

Professor

Neoplasm Metastasis

Colorectal Neoplasms

Liver Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Liver Diseases

Anti-Infective Agents

Oxaliplatin

Capecitabine

Metronidazole

Cetuximab

Liver Extracts

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Folinic Acid

Conventional treatment was performed according to the NCCN Guidelines for Colorectal Cancer 2023 Edition

SOX regimen chemotherapy, low dose cetuximab targeted therapy, and folic acid, vitamin A, metronidazole three-drug regimen were combined. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 \* patient's body surface area, d2-d15 was taken orally by S1, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 \* patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. These regimens last for 6 to 8 sessions.

Oxaliplatin via intravenous drip on d1 at a dose of 130mg/m2 × patient 's body surface area

Orally on d2-d15 at 20 mg three times daily

Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Folic acid

Capecitabine via orally on d2-d15 two times daily at a dose of 1000mg/m2 × patient 's body surface area.

Zhang Zhongguo, Doctor

In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. A one-arm randomized clinical trial was conducted, and the patients were grouped according to their treatment methods. The patients with metachronous liver metastases were used as the end point of the experiment to evaluate the blocking effect of quintuple therapy.

Patients diagnosed with colorectal cancer, clinical stage I to III, underwent radical surgery, and prehepatic CTC≥1 were enrolled. Patients were randomly divided into Conventional treatment group and Quintuple method treatment group. Patients in the Conventional treatment group received conventional treatment according to the NCCN Guidelines for Colorectal Cancer 2023 edition. For patients in the Quintuple method treatment group, Quintuple method intervention was adopted, that is, combined with SOX regimen chemotherapy, low-dose cetuximab targeted therapy and three-drug regimen of folic acid, vitamin A and metronidazole. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 \* patient's body surface area, d2-d15 was taken orally by Digio, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 \* patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. The above regimen lasted for 6 to 8 sessions, and enrolled patients were reviewed every 3 months for colorectal cancer-related tumor markers, including MRI and CT imaging. The primary endpoint was radiographically confirmed metachronous liver metastases, and the secondary endpoint was death, observed for 3 years.

Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection

The Metachronous liver metastasis rate is the proportion of CTC-positive patients with metachronous liver metastases after conventional therapy or quintuple method intervention.

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time.

Liaoning Tumor Hospital & Institute

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Inflammation

Alpha 1-Antitrypsin Deficiency

Alpha-1 Antitrypsin Deficiency

Reproductive Control Agents

Fluorodeoxyglucose F18

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Antioxidants

Dinoprost

Dinoprost tromethamine

Catalase

Alpha 1-Antitrypsin

Protein C Inhibitor

Tocopherol

Tocotrienol

Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.

The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients.

The FDG PET/CT imaging will be performed as part of typical medical procedures related to the diagnosis and monitoring of cancers at the Oncology Center in Bydgoszcz, Poland

Patients

Paweł Sutkowy, PhD

The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose (18F-FDG) integrated with computed tomography (CT) in the group of oncological patients.

FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.

Tumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.

In this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland.

Venous blood collected from the basilic vein from the study participants into two vacuum test tubes only once (from patients during FDG PET-CT diagnosis): for full blood (K2EDTA) and blood serum (clot activator and gel separator).

Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.

There is no the individual participant data (IPD) sharing plan.

Total antioxidant potential of blood serum in the participant

Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vitamin A Status in Patients With Vocal Fold Leukoplakia	NCT05323292	Vitamin A Vitamin A Defic... Leukoplakia Vocal Cord Neop...		18 Years -	University of Wisconsin, Madison
Pilot Trial of Supplemental Vitamin A and Nicotinamide	NCT05702398	Skin Cancer Kidney Transpla...	Vitamin A Nicotinamide Other: Placebo	18 Years -	Rhode Island Hospital
Investigator-initiated Clinical Trial of MIKE-1	NCT05064618	Pancreatic Canc...	Am80 Gemcitabine nab-Paclitaxel	20 Years - 79 Years	Nagoya University
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection	NCT05720559	Preventive Effe...	Oxaliplatin S1 Cetuximab Metronidazole Vitamin A Folic acid Capecitabine	18 Years - 80 Years	Liaoning Tumor Hospital & Institute
Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.	NCT03470857	Neoplasms Antioxidants Oxidative Stres... Lipid Peroxidat... Inflammation Lysosome Altera...	Patients	18 Years -	Nicolaus Copernicus University
Pilot Trial of Supplemental Vitamin A and Nicotinamide	NCT05702398	Skin Cancer Kidney Transpla...	Vitamin A Nicotinamide Other: Placebo	18 Years -	Rhode Island Hospital
Vitamin A Status in Patients With Vocal Fold Leukoplakia	NCT05323292	Vitamin A Vitamin A Defic... Leukoplakia Vocal Cord Neop...		18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for vitamin a

Every month we try and update this database with for vitamin a 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.

Spots Global Cancer Trial Database for vitamin a

Every month we try and update this database with for vitamin a 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.

Every month we try and update this database with for vitamin a 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.