Status:
WITHDRAWN
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer
Lead Sponsor:
Health Clinics Limited
Conditions:
Cancer
Overall Survival
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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 re...
Detailed Description
\*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 pro...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Male or female 18-85 years old;
- Diagnosed with cancer and have had such diagnosis confirmed by scan, blood markers and/or biopsy;
- Is receiving or will shortly receive standard of care therapy or has completed standard of care treatment; and
- Signed and dated written informed consent from the participant or LAR.
- Exclusion Criteria:
- Pregnant or lactating females or females who are planning a pregnancy during the course of the study;
- Major organ failure, renal, lung and liver failure;
- Participants having active liver disease or unexplained persistent elevation of serum transaminases \> 3 times the upper limit of normal;
- Participants with diabetic ketoacidosis or diabetic pre-coma;
- Participants with a creatinine clearance \< 60mL/min;
- History of cardiac or respiratory failure;
- History of recent myocardial infarction;
- Ileum, colon or stomach part or full removal rendering them unable to take the study medicines;
- Unable to eat or keep food or medicines down or is being fed intravenously;
- Is too frail and weak to withstand the study medicines in the opinion of the study doctor;
- Is Unlikely to survive more than 1 month under standard of care, in the opinion of the study doctor
- Hypersensitivity to any of the treatment drugs or excipients;
- If the patient is on any medicines contraindicated with the study medicines (see Appendix 3);
- 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;
- History or presence of alcohol or substance abuse;
- 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;
- Direct employee of the study site.
Exclusion
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02201381
Start Date
May 23 2022
End Date
September 23 2027
Last Update
July 18 2022
Active Locations (1)
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1
Care Oncology Clinic
London, United Kingdom, W1G 9PP