Neoplasms

Nervous System Diseases

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

ACTH-Secreting Pituitary Adenoma

Pituitary ACTH Hypersecretion

Adenoma

Pituitary Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pituitary Neoplasms

Endocrine Gland Neoplasms

Quality of Life

ACTH-secreting Pituitary Adenoma

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Blood sample 24hrs urinary cortisol and salivary cortisol, urinary labstick test, EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US ophthalmology examination spine X-Ray bone densitometry QoL questionnaires (SF-36, QoLCushing, Beck BDI-II)

Exams and questionnaires

Jerome Bertherat, MD, PhD

This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.

At inclusion the following will be investigated and recorded :

* demographic and personal medical history.
* Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism.
* Current medical treatment.
* Physical examination.
* Assessment of basal 24hrs urinary cortisol and salivary cortisol.

  - At baseline (i.e. before specific treatment of Cortisol excess):
* physical examination,
* routine biology,
* HbA1C, fasting glucose and oral glucose load,
* cholesterol, triglyceride, HDL \& LDL,
* coagulation and fibrinolysis investigation,
* 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
* EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US,
* ophthalmology examination,
* spine X-Ray, bone densitometry,
* QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).

Every year during a 3 years follow-up the following will be investigated :

* Current medical treatment.
* Physical examination.
* Assessment of basal routine biology,
* HbA1C, fasting glucose,
* cholesterol, triglyceride, HDL \& LDL,
* coagulation and fibrinolysis investigation,
* 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
* EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US,
* ophthalmology examination, bone densitometry,
* QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).

Cushing's Disease Complications

Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease

Evaluate the frequency of :

* metabolic complications (HbA1C, fasting glucose and oral glucose load, cholesterol, triglyceride, HDL \& LDL, coagulation and fibrinolysis investigation, 24hrs urinary cortisol and salivary cortisol, urinary labstick test)
* cardiovascular thromboembolic complications (EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US)
* bone complications (spine X-Ray, bone densitometry)
* quality of life alteration measured by questionnaires (SF36, QoLCushing, Beck BDI-II)

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Brain Neoplasms

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Antirheumatic Agents

Analgesics

Hypoglycemic Agents

Anti-Infective Agents

Antineoplastic Agents

Lipid Regulating Agents

Herbal and Botanical

Ibuprofen

Metformin

Doxycycline

Mebendazole

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Anthelmintics

Tubulin Modulators

Antimitotic Agents

Cola

Subjects will take the following treatments and have their data collected from their medical records every 3 months.

* Oral atorvastatin up to 80mg uid, for study duration.
* Oral metformin up to 1000mg uid, increased to bid if tolerated after 2 weeks, for study duration.
* Oral doxycycline 100mg uid, for study duration.
* Oral Mebendazole 100mg uid, for study duration.

While subjects are being treated with the four metabolic drugs, every 3 months they will bring in their medical records and data will be collected to determine the effect of the intervention

Metabolic treatment

Samir Agrawal, MRCP FRCPath

The purpose of this study is to determine the effectiveness of a regimen of selected metabolic treatments for patients with cancer in a real world setting and to conduct exploratory analysis on the relationship between the degree of response and changes in biochemical markers (such as glucose and lipid levels).

\*This study has been designed to collect data prospectively and to retrospectively analyse data on the metabolic treatments within the cancer clinic. The retrospective study is ongoing, while the prospective study has not yet started.\*

This is a real world study since this gives the best opportunity to properly examine the effect of multi-drug regimens in representative populations. Including a standard of care arm is inappropriate, in a population in which that standard of care has already been shown to be ineffective or intolerable.

Patients will be sent to the study clinic directly by their Health Care Professionals ("HCP's") .

The study will consist of a pre-screening visit to determine eligibility for inclusion into the study, an initiation visit and then a follow up visit every three months thereafter. If required, unscheduled visits may take place. Day 0 (baseline) for each patient will be the initiation visit when study treatment is started.

Prior to conducting any study-related procedures, subjects will provide written informed consent, eligibility will be assessed, a medical history and past medical records will be taken and vital signs will be measured. These records will include the stage of their disease, response to previous cancer therapy, their prior and current medications and any specific regimen they are currently on for their cancer. If prior medical records do not contain sufficient information to determine a baseline for the patient, additional blood tests and scans will be undertaken as appropriate.

Patients will be monitored quarterly thereafter when blood tests (e.g. safety parameters, glucose, cholesterol, immune response and cancer markers where applicable) and scans (where applicable) will be taken.

All patients will be on the same drug regimen (see below) at the same doses throughout the study. All patients will be followed up until they choose to leave the study, or death.

Data from all patients recruited to the study will be analysed using an Intention-to-treat (ITT) philosophy, so data will be included in the primary analysis irrespective of whether the dose regimen was followed throughout the study. If appropriate, and numbers allow, analysis will also be conducted on the Per Protocol population, comprising those patients who adhere to the regimen as prescribed.

Survival analysis methods will be used to estimate the Overall survival associated with the study regimen for each type of cancer. These estimates will be interpreted in the light of data obtained from the literature, and from eliciting expert opinion. Bayesian methods may be used where appropriate.

Tumour response, where applicable, will be summarised in tables and graphs. Estimates of response rates will be presented for each cancer type with confidence intervals.

The relationship between changes in biochemistry values (glucose, lipids) and efficacy outcomes (Progression Free Survival (PFS), Overall Survival (OS) and HRQoL) will be investigated graphically, or using other methods as appropriate.

Further exploratory analysis to investigate the effects of other factors such as age , ethnic backgrounds , cancer stage, and response to prior therapy, will also be conducted in order to try and characterise the profile of patients most likely to benefit from the study regimen.

The characteristics of patients on the regimen and those who do not stay on the regimen, for whatever reason, will be summarised to see whether there is any observed bias. If appropriate, methods will be used to adjust for any observed bias, for example using propensity scores. OS can then be assessed adjusted for this to try and mitigate for any possible risk of bias which can occur in uncontrolled studies. Furthermore, by enrolling all eligible patients over a specified time frame, it is hoped that the risk of bias should be further reduced. In addition, a large number of patients are expected to participate in the study.

Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer

A Non Randomised, Non Blinded Real World Trial of the Safety, Tolerability and Effectiveness of Metabolic Medicines for the Treatment of Cancer Compared Against Matched Controls

Adverse events reported by the subject or their HCP.

• Quarterly assessment of routine laboratory tests

Overall survival for all cancer types and for each cancer type (years and months)

Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type.

Tumour spread (metastasized) to other tissues/organs, for all cancer types and for each cancer type. This is measured as either 0 for no spread or 1 for confirmed spread.

Tumour number for all cancer types and for each cancer type

Cancer biomarkers for all cancer types and for each cancer type. Units of measurement vary depending on the cancer type. When biomarkers, either alone or in combination with other biomarkers, are raised above normal they are seen as predictive of cancer of progression. If returned to normal are indicative of treatment response.

Health Clinics Limited

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cushing's Disease Complications	NCT02568982	Cushing's Disea...	Exams and quest...	18 Years -	Assistance Publique - Hôpitaux de Paris
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited

Spots Global Cancer Trial Database for metabolic

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

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