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Trial record 1 of 1750 for:    care oncology | United Kingdom
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Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer (METRICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02201381
Recruitment Status : Withdrawn (Prospective recruitment not possible)
First Posted : July 28, 2014
Last Update Posted : July 18, 2022
Information provided by (Responsible Party):
Health Clinics Limited

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

Condition or disease Intervention/treatment Phase
Cancer Overall Survival Drug: Metabolic treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Matched historical control comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : May 23, 2022
Estimated Primary Completion Date : May 23, 2027
Estimated Study Completion Date : September 23, 2027

Arm Intervention/treatment
Experimental: Metabolic Treatment

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.
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
Other Names:
  • Metformin
  • Atorvastatin
  • Doxycycline
  • Mebendazole

Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 5 years ]
    Overall survival for all cancer types and for each cancer type (years and months)

Secondary Outcome Measures :
  1. Change in primary tumour size cancer types and by cancer type. [ Time Frame: up to 5 years ]
    Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type.

  2. Change in tumour spread (metastasis) [ Time Frame: up to 5 years ]
    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.

  3. Change in tumour number [ Time Frame: up to 5 years ]
    Tumour number for all cancer types and for each cancer type

  4. Change in cancer biomarkers (blood, urine or biopsy) [ Time Frame: up to 5 years ]
    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.

Other Outcome Measures:
  1. Incidence of treatment related adverse events [ Time Frame: 5 years ]

    Adverse events reported by the subject or their HCP.

    • Quarterly assessment of routine laboratory tests

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201381

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United Kingdom
Care Oncology Clinic
London, United Kingdom, W1G 9PP
Sponsors and Collaborators
Health Clinics Limited
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Principal Investigator: Samir Agrawal, MRCP FRCPath Care Oncology Clinic
Additional Information:

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Responsible Party: Health Clinics Limited
ClinicalTrials.gov Identifier: NCT02201381    
Other Study ID Numbers: Metabolic Cancer 001
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Health Clinics Limited:
Cancer Treatments
Cancer Palliative Care
Breast Cancer
Triple Negative Breast Cancer
Colon Cancer
Prostrate Cancer
Brain Cancer
Ovarian Cancer
Pancreatic Cancer
Existing Medicines
Licensed Medicines
Real World
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antinematodal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents