Cancer Clinical Trial
— METRICSOfficial title:
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
Verified date | July 2022 |
Source | Health Clinics Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 23, 2027 |
Est. primary completion date | May 23, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion criteria 1. Male or female 18-85 years old; 2. Diagnosed with cancer and have had such diagnosis confirmed by scan, blood markers and/or biopsy; 3. Is receiving or will shortly receive standard of care therapy or has completed standard of care treatment; and 4. Signed and dated written informed consent from the participant or LAR. Exclusion Criteria: 1. Pregnant or lactating females or females who are planning a pregnancy during the course of the study; 2. Major organ failure, renal, lung and liver failure; 3. Participants having active liver disease or unexplained persistent elevation of serum transaminases > 3 times the upper limit of normal; 4. Participants with diabetic ketoacidosis or diabetic pre-coma; 5. Participants with a creatinine clearance < 60mL/min; 6. History of cardiac or respiratory failure; 7. History of recent myocardial infarction; 8. Ileum, colon or stomach part or full removal rendering them unable to take the study medicines; 9. Unable to eat or keep food or medicines down or is being fed intravenously; 10. Is too frail and weak to withstand the study medicines in the opinion of the study doctor; 11. Is Unlikely to survive more than 1 month under standard of care, in the opinion of the study doctor 12. Hypersensitivity to any of the treatment drugs or excipients; 13. If the patient is on any medicines contraindicated with the study medicines (see Appendix 3); 14. Mentally incapacitated and no guardian able to sign on patients Clinical study protocol, version 5.0 METRICS TRIAL, Metabolic Cancer 001 5th Apr 2016 Confidential Page 5 of 65 behalf; 15. History or presence of alcohol or substance abuse; 16. Participation in a clinical trial of an investigational medicinal product that is viewed by the Study Physician to be a significant risk to the participant's safety; 17. Direct employee of the study site. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Care Oncology Clinic | London |
Lead Sponsor | Collaborator |
---|---|
Health Clinics Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of treatment related adverse events | Adverse events reported by the subject or their HCP.
• Quarterly assessment of routine laboratory tests |
5 years | |
Primary | Overall survival | Overall survival for all cancer types and for each cancer type (years and months) | up to 5 years | |
Secondary | Change in primary tumour size cancer types and by cancer type. | Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type. | up to 5 years | |
Secondary | Change in tumour spread (metastasis) | 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. | up to 5 years | |
Secondary | Change in tumour number | Tumour number for all cancer types and for each cancer type | up to 5 years | |
Secondary | Change in cancer biomarkers (blood, urine or biopsy) | 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. | up to 5 years |
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