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

This study is currently recruiting participants.
Verified October 2016 by Abiodun Popoola, Lagos State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936064
First Posted: September 5, 2013
Last Update Posted: November 1, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abiodun Popoola, Lagos State University
  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: 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.

Resource links provided by NLM:


Further study details as provided by Abiodun Popoola, 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

Information from the National Library of Medicine

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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
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
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:
Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.
Bröhan M, Jerkovic V, Collin S. Potentiality of red sorghum for producing stilbenoid-enriched beers with high antioxidant activity. J Agric Food Chem. 2011 Apr 27;59(8):4088-94. doi: 10.1021/jf1047755. Epub 2011 Mar 7.
Yang L, Browning JD, Awika JM. Sorghum 3-deoxyanthocyanins possess strong phase II enzyme inducer activity and cancer cell growth inhibition properties. J Agric Food Chem. 2009 Mar 11;57(5):1797-804. doi: 10.1021/jf8035066.
Kayodé AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25.
Shih CH, Siu SO, Ng R, Wong E, Chiu LC, Chu IK, Lo C. Quantitative analysis of anticancer 3-deoxyanthocyanidins in infected sorghum seedlings. J Agric Food Chem. 2007 Jan 24;55(2):254-9.
Camargo Filho I, Cortez DA, Ueda-Nakamura T, Nakamura CV, Dias Filho BP. Antiviral activity and mode of action of a peptide isolated from Sorghum bicolor. Phytomedicine. 2008 Mar;15(3):202-8. Epub 2007 Sep 24.
Burdette A, Garner PL, Mayer EP, Hargrove JL, Hartle DK, Greenspan P. Anti-inflammatory activity of select sorghum (Sorghum bicolor) brans. J Med Food. 2010 Aug;13(4):879-87. doi: 10.1089/jmf.2009.0147.
Park JH, Darvin P, Lim EJ, Joung YH, Hong DY, Park EU, Park SH, Choi SK, Moon ES, Cho BW, Park KD, Lee HK, Kim MJ, Park DS, Chung IM, Yang YM. Hwanggeumchal sorghum induces cell cycle arrest, and suppresses tumor growth and metastasis through Jak2/STAT pathways in breast cancer xenografts. PLoS One. 2012;7(7):e40531. doi: 10.1371/journal.pone.0040531. Epub 2012 Jul 6.
Wu L, Huang Z, Qin P, Yao Y, Meng X, Zou J, Zhu K, Ren G. Chemical characterization of a procyanidin-rich extract from sorghum bran and its effect on oxidative stress and tumor inhibition in vivo. J Agric Food Chem. 2011 Aug 24;59(16):8609-15. doi: 10.1021/jf2015528. Epub 2011 Jul 29.
Devi PS, Kumar MS, Das SM. Evaluation of antiproliferative activity of red sorghum bran anthocyanin on a human breast cancer cell line (mcf-7). Int J Breast Cancer. 2011;2011:891481. doi: 10.4061/2011/891481. Epub 2011 Oct 16.
Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4.
Benson KF, Beaman JL, Ou B, Okubena A, Okubena O, Jensen GS. West African Sorghum bicolor leaf sheaths have anti-inflammatory and immune-modulating properties in vitro. J Med Food. 2013 Mar;16(3):230-8. doi: 10.1089/jmf.2012.0214. Epub 2013 Jan 5.
Tayo AO, Dosunmu AO, Akinola IO, Adewunmi A, Oloyede OA, Akinbami AA, Osikomaiya BI, Makanjuola SB. An open-label, randomized, parallel-group comparative study of the efficacy of sorghum bicolor extract in preoperative anemia. Nutrition. 2017 Jan;33:113-117. doi: 10.1016/j.nut.2016.05.005. Epub 2016 May 18.
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 )
First Submitted: May 18, 2013
First Posted: September 5, 2013
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:
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


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