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The Safety and Efficacy of Jobelyn in the Treatment of Breast Cancer Patients

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: NCT01936064
Recruitment Status : Unknown
Verified October 2016 by Abiodun Popoola, Lagos State University.
Recruitment status was:  Recruiting
First Posted : September 5, 2013
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Abiodun Popoola, Lagos State University

Brief Summary:
To determine the effective functionality/potency of Jobelyn as an immunologic and haematologic booster in Breast cancer patients (start-off), thus improving the outlook and the quality of life of such patients generally

Condition or disease Intervention/treatment Phase
Haematological Abnormality Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6 Drug: Placebo + Cyclophosphamide - Epirubicin 6 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Randomized, Blinded Study to Demonstrate the Effectiveness of Jobelyn for the Treatment of Breast Cancer Patients.
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Jobelyn + Cyclophosphamide-Epirubicin6
Cyclophosphamide- Epirubicin 6 course regimen to be used with Jobelyn
Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6
Jobelyn (dietary Supplement) to be used with Cyclophosphamide-Epirubicin6
Other Name: Sorghum bicolor extract

Active Comparator: Placebo + Cyclophosphamide- Epirubicin 6
Routine drugs for treatment of Breast Cancer used with Placebo
Drug: Placebo + Cyclophosphamide - Epirubicin 6
Routine drugs for the treatment of breast cancer to be used with Placebo
Other Name: Breast Cancer drugs




Primary Outcome Measures :
  1. Natural Killer Cells Expression [ Time Frame: 6 months ]
    Evaluation of the expression of activated natural killer cells CD3-CD56+CD69+ after treatment with Jobelyn


Secondary Outcome Measures :
  1. Use of health related quality of life measures tool Safety Fractor-36 and self reporting questionnaires [ Time Frame: 6 months ]
    Subjects would use form Safety Fractor-36 to score aspects of well-being

  2. Hematocrit Changes [ Time Frame: 6 months ]
    Changes in levels of hematocrit after treatment with Jobelyn



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women with histologically confirmed breast cancer who had undergone complete or segmental mastectomy plus axillary node dissection were included

Exclusion Criteria:

Patients were excluded if they had distant metastases residual disease in the breast or axilla other serious medical illnesses, or a previous cancer. Women considering pregnancy or using hormones were excluded

Patients who refuse to sign consent form


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): NCT01936064


Contacts
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Contact: Abiodun Popoola, M.D. 2348033021434 pabiodun2001@yahoo.com

Locations
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Nigeria
Lagos State University Teaching Hospital Recruiting
Ikeja, Lagos, Nigeria, 100001
Contact: Abiodun Popoola, M.D.    2348033021434    okubena@health-forever.com   
Principal Investigator: Abiodun Popoola, M.D.         
Lagos State University Recruiting
Ikeja, Lagos, Nigeria, 100001
Contact: Abiodun Popoola, M.D.    2348033021434    pabiodun2001@yahoo.com   
Sub-Investigator: A. O. Dosunmu, M.D.         
Sub-Investigator: O A Fatiregun, M.D.         
Sub-Investigator: N S Bello, M.D.         
Sub-Investigator: S Makanjuola, MD         
Sub-Investigator: A I Igwilo, MD         
Sponsors and Collaborators
Lagos State University
Investigators
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Principal Investigator: Abiodun Popoola, M.D. Lagos State University

Publications:
Newly isolated compounds from West African Sorghum bicolor leaf sheaths Jobelyn® show potential in cancer immunosurveillance DOI: http://dx.doi.org/10.14312/2052-4994.2016-6

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Responsible Party: Abiodun Popoola, CONSULTANT IN THE DEPARTMENT OF ONCOLOGY LASUTH, Lagos State University
ClinicalTrials.gov Identifier: NCT01936064    
Other Study ID Numbers: LASUTH/09/2012
HEALTH FOREVER PRODUCT LTD ( Other Grant/Funding Number: LAGOS STATE UNIVERSITY )
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Abiodun Popoola, Lagos State University:
Breast Cancer
Jobelyn
Sorghum bicolor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors