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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Lagos State University
Sponsor:
Information provided by (Responsible Party):
Abiodun Popoola, Lagos State University
ClinicalTrials.gov Identifier:
NCT01936064
First received: May 18, 2013
Last updated: October 29, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Haematological Abnormality
Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6
Drug: Placebo + Cyclophosphamide - Epirubicin 6
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:


Further study details as provided by Lagos State University:

Primary Outcome Measures:
  • 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:
  • 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

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


Estimated Enrollment: 60
Study Start Date: October 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936064

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

Locations
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
Principal Investigator: Abiodun Popoola, M.D. Lagos State University
  More Information

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

Responsible Party: Abiodun Popoola, CONSULTANT IN THE DEPARTMENT OF ONCOLOGY LASUTH, Lagos State University
ClinicalTrials.gov Identifier: NCT01936064     History of Changes
Other Study ID Numbers: LASUTH/09/2012
HEALTH FOREVER PRODUCT LTD ( Other Grant/Funding Number: LAGOS STATE UNIVERSITY )
Study First Received: May 18, 2013
Last Updated: October 29, 2016

Keywords provided by Lagos State University:
Breast Cancer
Jobelyn
Sorghum bicolor

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 24, 2017