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Effect of Preoperative Curcumin in Breast Cancer Patients (EPC)

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: NCT03847623
Recruitment Status : Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nur Aishah Mohd Taib, University of Malaya

Brief Summary:
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Curcumin Other: Placebo Not Applicable

Detailed Description:
Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Preoperative Curcumin in Breast Cancer Patients
Actual Study Start Date : June 18, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin
Capsules, taken orally, 8g per day (Bi-daily dosing)
Dietary Supplement: Curcumin
Natural compound, active ingredient of turmeric, in bi-daily dosing

Placebo Comparator: Placebo
Capsules, taken orally, bi-daily dosing
Other: Placebo
Placebo tablets at bi-daily dosing




Primary Outcome Measures :
  1. Tumour infiltrating lymphocytes (TILs) [ Time Frame: For 2 to 4 weeks ]
    Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group


Secondary Outcome Measures :
  1. FOXP3 [ Time Frame: For 2 to 4 weeks ]
    Immunohistochemistry analysis

  2. CD68 [ Time Frame: For 2 to 4 weeks ]
    Immunohistochemistry analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with operable breast cancer
  • Life expectancy of at least 3 months
  • Adequate organ function
  • No allergy to curcumin
  • Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria:

  • Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs
  • Uncontrolled concurrent illness
  • Patient of anti platelet medications
  • Pregnant / breast feeding
  • Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications
  • Patients with bleeding tendency, bleeding disorders and abnormal bleeding/clotting profile

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): NCT03847623


Locations
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Malaysia
University of Malaya Medical Center
Kuala Lumpur, Malaysia
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Nur Aishah Taib, MBBS University of Malaya

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Responsible Party: Nur Aishah Mohd Taib, Professor, University of Malaya
ClinicalTrials.gov Identifier: NCT03847623     History of Changes
Other Study ID Numbers: 20149-582
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action