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

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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
Information provided by (Responsible Party):
Abiodun Popoola, Lagos State University

Tracking Information
First Submitted Date  ICMJE May 18, 2013
First Posted Date  ICMJE September 5, 2013
Last Update Posted Date November 1, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Natural Killer Cells Expression [ Time Frame: 6 months ]
Evaluation of the expression of activated natural killer cells CD3-CD56+CD69+ after treatment with Jobelyn
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2013)
Haematocrit [ Time Frame: 6 months ]
Changes in haematocrit compared in both arms of the study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2013)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Jobelyn in the Treatment of Breast Cancer Patients
Official Title  ICMJE A Prospective Phase II Randomized, Blinded Study to Demonstrate the Effectiveness of Jobelyn for the Treatment of Breast Cancer Patients.
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
Detailed Description

Breast cancer is one of the most frequent malignant tumor of women in Nigeria. In Nigeria, among the urban women, the numbers of breast cancer patients were increasing annually, both to aging of the population and increase in age-specific incidences. Case control studies in parts of the country have identified the factors such as null parity, late age at marriage, and late age at first pregnancy are important risk factors. It has also been suggested that western dietary influences changed the lifestyle of urban women could be one of the major causes of the slowly rising incidence of breast cancer in Nigeria. Therefore early detection and search for potential anti-tumour compounds are important in the control of breast cancer.Standard treatment modalities have improved the overall outlook and quality of life for women with breast cancer; however, the fact that more than 50% still succumb to disease highlights the need for new therapeutic approaches and identification of new therapeutic targets.

Jobelyn is made from Sorghum bicolor which grows abundantly in many parts of the world. Major component analysis of the raw materials and the finished product showed that the herbal product contains oligomeric and polymeric proanthocyanidin (OPCs) which are a class of flavonoid complexes. They are also referred to as condensed tannins. They were first discovered in 1948 by Jacques Masquelier, who developed and later patented techniques for the extraction of proanthocyanidin from pine needles and grape seeds. They can also be found in apples, coconut, cocoa beans, black currant, green tea, black tea. Cocoa beans contain the highest concentrations.

In preliminary research, proanthocyanidin was reported to have anti-mutagenic activity. Studies also show that proanthocyanidin antioxidant capabilities are 20 times more powerful than vitamin C and 50 times more potent than vitamin E2. They also work directly to help strengthen all the blood vessels and improve the delivery of oxygen to the cells. Having affinity for cell membranes, they provide nutritional support to reduce capillary permeability and fragility. These they owe to their role in stabilization of collagen and maintenance of elastin.

Oligomeric proanthocyanidin helps in cancer treatment by inhibiting the initiation and progress of cancer cells. This is why according to a study, it was found that Jobelyn water extract had a stronger effect on increasing Cluster of Differentiation 69 expression in Natural Killer cells (higher cytotoxic activity) while Jobelyn Ethyl Alcohol extract had the greatest effect on increasing Cluster of Differentiation 69 expression in Natural Killer T-cells, T-cells and monocytes (activation & proliferation). In addition to its selective cytotoxicity property, oligomeric proanthocyanidin may up-regulate certain apoptosis promoter genes and down-regulate apoptosis-inhibitor genes in cancerous cells.

3-Deoxyanthocyanidins are a rare type of flavonoids restricted to a few plant species. They are the major pigments in flowers of sinningia (Sinningia cardinalis) and are found in silk tissues of certain maize lines. Sorghum is the only dietary source for 3-deoxyanthocyanidins, which are present in large quantities in the bran of some cultivars . Many plants use secondary metabolites to protect themselves against pathogen attack. In sorghum, this defense response is an active process resulting in the accumulation of high levels of 3-deoxyanthocyanidin phytoalexins in infected tissues. Luteolinidin and apigeninidin are the two major 3-deoxyanthocyanidins. Flavonoids are increasingly recognized for their range of health benefits, such as reducing the risks of cardiovascular diseases and cancers due to their antioxidant, anti-inflammatory, and chemoprotective properties. In particular, anthocyanins and anthocyanidins from different sources were shown to suppress proliferation and induce apoptosis in cancer cell lines. In a recent study, 3-deoxyanthocyanidins were found to have antioxidant properties similar to those of anthocyanins, but they are more stable to power of hydrogen, temperature, and light changes,suggesting that they could serve as an alternative source of natural pigments with nutraceutical properties.

The unique properties of 3-deoxyanthocyanidins may extend to their biochemical activity as well. For example, Shih et al. recently demonstrated that the major sorghum 3-deoxyanthocyanidins aglycons, apigeninidin and luteolinidin, were more cytotoxic to human cancer cells than their anthocyanidin analogues, cyanidin and pelargonidin

Recent research publication confirmed that the variety of Sorghum bicolor from which Jobelyn was produced contained two unique compounds which are being reported for the first time in Sorghum and in nature and these compounds have been tested in vitro for their anti-inflammatory properties using Ibuprofen as control. They showed superior results to Ibuprofen for their safety and efficacy properties. Hitherto, 3-deoxyanthocyanidins which have been known to contain two main compounds, apigeninidin and luteolinidin has now been increased to four compounds, courtesy of the two new additions discovered from the unique Sorghum variety which is the main ingredient of Jobelyn.

Anaemia, commonly defined as a haemoglobin level of <14g/dl in men and <12g/dl in women, occurs in over 30% of cancer patients at any point in time, and its incidence increases with treatment and disease progression. This anaemia could be related to the patient (haemoglobinopathies, gastrointestinal problems, thalassemia, etc.), related to the disease (bone marrow infiltration, bowel resection, hypersplenism, diminished nutritional state) or related to therapy (drug-induced haemolysis, hypoplasia of bone marrow-bearing areas such as the pelvis secondary to radiotherapy, bone marrow and renal toxicity secondary to chemotherapy, etc.). Inflammatory cytokines such as tumour necrotic factor-alpha and interleukin-6, among others, play a major role in the pathophysiology of anaemia in the cancer patient, not only through complex mechanisms of the purely inflammatory situation but also through genetic regulatory aspects of erythropoiesis.

Oxidative stress brought about by overwhelming of the body by free radicals from the disease itself (cancer) and the therapy both contribute to increased haemolysis and immune depression, as these degrade cell linings and disrupt many biochemical pathways. Jobelyn, which contains majorly oligomeric proanthocyanidin, prevent cell membrane damage by disrupting the biochemical formation of free radicals, thus preventing the release of haemolytic inflammatory cytokines.

In tandem, by mopping up free radicals, it would be found useful in delaying the onset of opportunistic infection in cancer patients, which in itself can provoke further haemolysis. However, these functions are still being proven in Human Clinical Trials which has so far been carried out in two research centres in Nigeria, though primarily amongst sickle cell and HIV/AIDS patients1. However, this experimental trial is now being extended to cancer patients to assess its usefulness in this condition.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Haematological Abnormality
Intervention  ICMJE
  • Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6
    Jobelyn (dietary Supplement) to be used with Cyclophosphamide-Epirubicin6
    Other Name: Sorghum bicolor extract
  • Drug: Placebo + Cyclophosphamide - Epirubicin 6
    Routine drugs for the treatment of breast cancer to be used with Placebo
    Other Name: Breast Cancer drugs
Study Arms  ICMJE
  • Active Comparator: Jobelyn + Cyclophosphamide-Epirubicin6
    Cyclophosphamide- Epirubicin 6 course regimen to be used with Jobelyn
    Intervention: Dietary Supplement: Jobelyn + Cyclophosphamide-Epirubicin6
  • Active Comparator: Placebo + Cyclophosphamide- Epirubicin 6
    Routine drugs for treatment of Breast Cancer used with Placebo
    Intervention: Drug: Placebo + Cyclophosphamide - Epirubicin 6
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 30, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2013)
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01936064
Other Study ID Numbers  ICMJE LASUTH/09/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Abiodun Popoola, Lagos State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lagos State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abiodun Popoola, M.D. Lagos State University
PRS Account Lagos State University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP