Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02201381
Other study ID # Metabolic Cancer 001
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date May 23, 2022
Est. completion date September 23, 2027

Study information

Verified date July 2022
Source Health Clinics Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 relationship between the degree of response and changes in biochemical markers (such as glucose and lipid levels).


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 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metabolic treatment
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

Locations

Country Name City State
United Kingdom Care Oncology Clinic London

Sponsors (1)

Lead Sponsor Collaborator
Health Clinics Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients