NCT01936064

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
3.1 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

May 18, 2013

Last Update Submit

October 29, 2016

Conditions

Haematological Abnormality

Keywords

Breast CancerJobelynSorghum bicolor

Outcome Measures

Primary Outcomes (1)

  • Natural Killer Cells Expression

    Evaluation of the expression of activated natural killer cells CD3-CD56+CD69+ after treatment with Jobelyn

    6 months

Secondary Outcomes (2)

  • Use of health related quality of life measures tool Safety Fractor-36 and self reporting questionnaires

    6 months

  • Hematocrit Changes

    6 months

Study Arms (2)

Jobelyn + Cyclophosphamide-Epirubicin6

ACTIVE COMPARATOR

Cyclophosphamide- Epirubicin 6 course regimen to be used with Jobelyn

Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6

Placebo + Cyclophosphamide- Epirubicin 6

ACTIVE COMPARATOR

Routine drugs for treatment of Breast Cancer used with Placebo

Drug: Placebo + Cyclophosphamide - Epirubicin 6

Interventions

Jobelyn + Cyclophosphamide-Epirubicin6DIETARY_SUPPLEMENT

Jobelyn (dietary Supplement) to be used with Cyclophosphamide-Epirubicin6

Also known as: Sorghum bicolor extract
Jobelyn + Cyclophosphamide-Epirubicin6
Placebo + Cyclophosphamide - Epirubicin 6DRUG

Routine drugs for the treatment of breast cancer to be used with Placebo

Also known as: Breast Cancer drugs
Placebo + Cyclophosphamide- Epirubicin 6

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lagos State University Teaching Hospital

Ikeja, Lagos, 100001, Nigeria

RECRUITING

Lagos State University

Ikeja, Lagos, 100001, Nigeria

RECRUITING

Related Publications (14)

  • 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.

    PMID: 22489620BACKGROUND

  • Brohan 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.

    PMID: 21381750BACKGROUND

  • 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.

    PMID: 19256554BACKGROUND

  • Kayode 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.

    PMID: 21322653BACKGROUND

  • 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. doi: 10.1021/jf062516t.

    PMID: 17227050BACKGROUND

  • 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. doi: 10.1016/j.phymed.2007.07.059. Epub 2007 Sep 24.

    PMID: 17890069BACKGROUND

  • 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.

    PMID: 20673059BACKGROUND

  • 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.

    PMID: 22792362BACKGROUND

  • 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.

    PMID: 21780844BACKGROUND

  • 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.

    PMID: 22312562BACKGROUND

  • Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4. doi: 10.1021/jf0510384.

    PMID: 16076098BACKGROUND

  • 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.

    PMID: 23289787BACKGROUND

  • 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.

    PMID: 27461168BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Abiodun Popoola, M.D.

    Lagos State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abiodun Popoola, M.D.

CONTACT

2348033021434pabiodun2001@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CONSULTANT IN THE DEPARTMENT OF ONCOLOGY LASUTH

Study Record Dates

First Submitted

May 18, 2013

First Posted

September 5, 2013

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

NG(2)