Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Hyaluronic Acid

Diclofenac

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Adjuvants, Immunologic

Immunologic Factors

Viscosupplements

Protective Agents

3 % diclofenac in 2.5% hyaluronic acid gel (Solaraze® 3% gel) is applied twice daily in the treatment area. 3 % diclofenac in 2.5% hyaluronic acid gel (Solaraze® 3% gel) is to be applied 1cm beyond the single AK.

3% diclofenac in 2.5% hyaluronic acid gel

The rationale of this study is to investigate the effects of topical diclofenac on tumor metabolism in the treatment of actinic keratoses in immunocompetent and immunocompromised patients.

Study hypothesis is that topical diclofenac lowers lactate level in skin biopsies of actinic keratoses. Planned number of patients is 38.

This study is a monocenter study investigating the effects of 3% diclofenac in 2.5% hyaluronic acid gel on tumor metabolism in the treatment of actinic keratoses. Treatment duration is 3 months. Skin biopsies will be obtained before treatment, at the end of the treatment and four weeks after the treatment. Control biopsies at visit 1 and 3 are performed in healthy, sun damaged and untreated skin. Evaluation of efficacy will be performed at the end of the treatment and four weeks after the treatment.

Duration of treatment is 3 months (±4 weeks). Approximately 0,5g Solaraze® 3% gel is applied on a 5cm x 5cm lesion. Solaraze® 3% gel is applied twice daily on the study lesions.

Neoplastic cells show an increased glucose metabolism and glycolysis which is associated with high lactate concentrations. There is also data for several tumor entities that high levels of lactate in the tumor are associated with tumor progression, metastasis and poor clinical outcome. Kreutz et al. demonstrated that diclofenac inhibits tumor cell proliferation in vitro and tumor growth in vivo via COX-independent effects on glucose metabolism. Diclofenac is taken up by tumor cells and inhibits tumor cell proliferation through inhibition of the oncogene MYC and subsequently glycolysis and block of lactate transport. MYC regulates genes involved in glycolysis and is upregulated in neoplastic cells, which is in line with the metabolic switch to glycolysis, the so called "Warburg effect", that cancer cells show. Although these results were found in vitro using human melanoma cells and in vivo in a mouse model, a similar mechanism of action is assumed to be relevant for the treatment of actinic keratoses with topical diclofenac. However tumor metabolism in diclofenac-treated actinic keratoses has never been investigated. To investigate the mechanism of action of diclofenac in the treatment of actinic keratoses, a clinical study analyzing particularly lactate levels, glycolysis and inflammatory infiltrate is needed.

Effects of Topical Diclofenac on Tumor Metabolism

Prospective, Controlled and Monocentric Study to Evaluate the Effects of Topical 3% Diclofenac in 2.5% Hyaluronic Acid Gel on Tumor Metabolism in the Treatment of Actinic Keratoses in Immunocompetent and Immunocompromised Patients

Assessment of the effects of topical 3% diclofenac in 2.5% hyaluronic acid gel on lactate level in skin biopsies of actinic keratoses. Skin biopsies of actinic keratoses are obtained prior to treatment and 4 weeks after the treatment.

Assessment of the effects of topical 3% diclofenac in 2.5% hyaluronic acid gel on lactate level in skin biopsies of actinic keratoses compared to untreated sun damaged, healthy skin in a subpopulation

Glycolysis-relevant proteins evaluated using PCR and Westernblot techniques

Metabolic changes (e.g. glucose, amino acids) evaluated by NMR methods and bioluminescence imaging techniques

German Research Foundation

University Hospital Regensburg

Professor Dr.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Lung Neoplasms

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

detect the contents of glucose metabolism molecules using mass spectrum

Diagnostic test

Detect the contents of glucose metabolism molecules in the tumor and adjacent normal samples of about 100 patients with lung adenocarcinoma using mass spectroscopy. Analyze the correlation between the contents and the clinicopathological characteristics and survival.

Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma

Shanghai Zhongshan Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Topical Diclofenac on Tumor Metabolism	NCT01935531	Actinic Keratos...	3% diclofenac i...	18 Years -	University Hospital Regensburg
Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma	NCT03641105	Lung Cancer Glycolysis Diagnosis Survival	Diagnostic test	18 Years -	Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for glycolysis

Every month we try and update this database with for glycolysis 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 glycolysis

Every month we try and update this database with for glycolysis 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 glycolysis 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.