Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742596
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
King Hussein Cancer Center
Information provided by (Responsible Party):
Lana M. Agraib, University of Jordan

Brief Summary:

Colorectal cancer (CRC) is one of the most common types of cancer worldwide in general and in Jordan in specific. The studies that investigate the role of Probiotics supplementation in improving the inflammatory response, gastrointestinal toxicity and life quality of patients with colorectal cancer during radiotherapy are limited. So, this study aimed to study the effect of probiotics on the response of inflammatory markers, gastrointestinal toxicity, and quality of life in patients with colorectal cancer during radiation therapy.

An interventional double-blind randomized clinical trial (RCT) design will be used in this study. Forty patients will be recruited and randomly assigned to the placebo group (n=20) to receive 3 times a day placebo capsules; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The demographic data, anthropometric measurements, Cancer Quality of Life Questionnaire and blood samples will be collected at baseline and at end of radiation therapy. Interleukin-6, interleukin-1,interleukin-10 IL-10, C-reactive protein, tumor necrosis factor alpha and complete blood count (CBC) will be measured.

The results will approve or disapprove the beneficial effect of using probiotics as adjuvant therapy for CRC patient and other types of cancer to reduce the side effects of radiotherapy and raise body weight as well as improving their quality of life.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Probiotic Formula Capsule Drug: Placebos Phase 2 Phase 3

Detailed Description:

To meet the objectives of the study, an interventional double-blind randomized clinical trial (RCT) design will be used in this study. A placebo group will be included parallel with the treatment group in this trail. Forty patients (aged 35-65 years) who recently diagnosed with CRC will be recruited conveniently from the radiation oncology clinic at the King Hussein Cancer Center (KHCC), Amman, Jordan. Patients who meet the inclusion criteria and agree to participate will be centrally randomized to probiotic supplementation group or placebo group using computer-generated random numbers, that balanced allocation to groups A and B: in successive blocks each containing 20 patients each stratified by gender. The duration of intervention will be 5 weeks, from the day of radiation until the end of treatment.

For the participants, the King Hussein Cancer Center (KHCC) hospital setting will be utilized for data collection. The patients will be recruited over 12 months and all patients will be asked to sign a written informed consent before enrollment. The patients will randomly be assigned to the placebo group (n=20), to receive 3 times a day placebo capsules contain polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The duration of the intervention (administration of probiotics) will be start 10-14 days before radiotherapy and continue over the 5 weeks duration of treatment under the supervision of the treating physician and end with the end of radiation therapy. The blood sample will be collected at baseline and at end of radiation therapy and 10-14 days after the radiation therapy.

The demographic data of each subject will be collected such as; gender, age, body mass index (BMI), tumor location, malignant tumors stage, tumor differentiation, educational level, occupation, family history, smoking, dietary and physical activity. At baseline and end line of the radiation therapy a Cancer Quality of Life Questionnaire C30 (QLQ-C30) will be collected and blood sample tests will be withdrawn and the following biochemical variables will be measured: immunoglobulin G, immunoglobulin M, immunoglobulin A, interleukin-6 (IL-6), C-reactive protein (CRP), interleukin-1(IL-1), interleukin-10(IL-10), interleukin-12 (IL-12), Tumor necrosis factor alpha (TNF-α) and complete blood count (CBC).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy on the Immune System Among Colorectal Cancer Patients
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic Formula Capsule
In this intervention arm the patients will receive oral viable capsules of probiotic contain (1*10 10 colony forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus , Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
Drug: Probiotic Formula Capsule
The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 7 weeks.
Other Name: Treatment

Placebo Comparator: Placebos
In this intervention arm Placebo arm received three oral viable capsules daily, containing polysaccharides, without any viable probiotics matching the probiotic capsules in appearance, smell, and taste.
Drug: Placebos
The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 7 weeks.
Other Name: Control




Primary Outcome Measures :
  1. The level of Immunoglobulin (Ig) A [ Time Frame: Through study completion, an average of 1 year ]
    The level of Immunoglobulin (Ig) A in g/L at both baseline and end line of intervention

  2. The level of Immunoglobulin (Ig) G [ Time Frame: Through study completion, an average of 1 year ]
    The level of Immunoglobulin (Ig) G in g/L at both baseline and end line of intervention

  3. The level of Immunoglobulin (Ig) M [ Time Frame: Through study completion, an average of 1 year ]
    The level of Immunoglobulin (Ig) M in g/L at both baseline and end line of intervention

  4. The Level of Interleukin (IL)-6 [ Time Frame: Through study completion, an average of 1 year ]
    The Level of Interleukin (IL)-6 in pg/ml at both baseline and end line of intervention

  5. The Level of Interleukin (IL)-1 [ Time Frame: Through study completion, an average of 1 year ]
    The Level of Interleukin (IL)-1 in pg/ml at both baseline and end line of intervention

  6. The Level of Interleukin (IL)-10 [ Time Frame: Through study completion, an average of 1 year ]
    The Level of Interleukin (IL)-10 in pg/ml at both baseline and end line of intervention

  7. The Level of Tumor Necrosis Factor (TNF)-α [ Time Frame: Through study completion, an average of 1 year ]
    The Level of TNF-α in pg/ml at both baseline and end line of intervention

  8. The Level of C-reactive protein (CRP) [ Time Frame: Through study completion, an average of 1 yea ]
    The Level of CRP in mg/ml at both baseline and end line of intervention


Secondary Outcome Measures :
  1. Quality of Life of patients [ Time Frame: Through study completion, an average of 1 year ]
    The average score of the general quality of life (QoL) subscales assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC-QLQ) which use five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting) range from"Not at A Quite Very" to "Very Much " , and a single global health status/QoL scale range from one (very poor) to 7(Excellent) . In addition, the questionnaire contains five symptom scales that are commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and the perceived financial impact of the disease scale that range from"Not at A Quite Very" to "Very Much ".

  2. The gastrointestinal toxicity [ Time Frame: Through study completion, an average of 1 year ]
    Number and percent of participants with treatment-related adverse events as assessed by NCI Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE) change from baseline in the occurrences and grad of Adverse Events on grading scale at 5 Weeks


Other Outcome Measures:
  1. The level of White blood cell count (WBC) [ Time Frame: Through study completion, an average of 1 yea ]
    he level of WBC as cells/ul at both baseline and end line of intervention

  2. The level of red blood cell count (RBC) [ Time Frame: Through study completion, an average of 1 yea ]
    The level of RBC as cells/ul at both baseline and end line of intervention

  3. The mean corpuscular volume (MCV) [ Time Frame: Through study completion, an average of 1 yea ]
    The MCV in fl at both baseline and end line of intervention

  4. The mean corpuscular hemoglobin (MCH) [ Time Frame: Through study completion, an average of 1 yea ]
    The MCH in pg at both baseline and end line of intervention

  5. The mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: Through study completion, an average of 1 yea ]
    The MCH in g/dl at both baseline and end line of intervention

  6. The Platelet count [ Time Frame: Through study completion, an average of 1 yea ]
    The Platelet count as cells/ ul at both baseline and end line of intervention

  7. The of Hemoglobin [ Time Frame: Through study completion, an average of 1 yea ]
    The Hemoglobin in g/dl at both baseline and end line of intervention

  8. The mean platelet volume (MPV) [ Time Frame: Through study completion, an average of 1 yea ]
    The MPV in fl at both baseline and end line of intervention

  9. The level of lymphocytes [ Time Frame: Through study completion, an average of 1 yea ]
    The number of lymphocytes cells at both baseline and end line of intervention

  10. The level of Monocytes [ Time Frame: Through study completion, an average of 1 yea ]
    The number of Monocytes cells at both baseline and end line of intervention

  11. The level of eosinophils [ Time Frame: Through study completion, an average of 1 yea ]
    The number of eosinophils cells at both baseline and end line of intervention

  12. The level of basophils [ Time Frame: Through study completion, an average of 1 yea ]
    The number of basophils cells at both baseline and end line of intervention

  13. The level of neutrophils [ Time Frame: Through study completion, an average of 1 yea ]
    The number of neutrophils cells at both baseline and end line of intervention



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.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women,
  2. Aged from 35- 65 years with histologically proven CRC and
  3. Histologically proven CRC with stage I, II, III
  4. Will exposed newly to radiotherapy with the absence of any psychological, sociological or geographical condition that potentially affects the compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

  1. Active infection treated by antibiotic therapy or recent infection or recent antibiotic use;
  2. Severe cardiovascular and cerebrovascular diseases that could not tolerate radical surgery;
  3. Recent use of probiotics, prebiotics, or synbiotic;
  4. Evidence of immunodeficiency;
  5. Cancer stage IV
  6. Pregnancy,
  7. Recent/concurrent admission to ER
  8. Co-existence of other malignant neoplasms, no other type of cancer in the past 5 years, any serious concomitant systemic disorders or diseases incompatible with the study.

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): NCT03742596


Contacts
Layout table for location contacts
Contact: Lana M Agraib, MSc 00692795152669 lanamg2007@yahoo.com
Contact: Fawzi Abuhijla, MD,MSc 0069277764888 FHijle@khcc.jo

Locations
Layout table for location information
Jordan
King Hussein Cancer Center Recruiting
Amman, Jordan
Contact: Lana M. Agraib, MSc    00692795125669    lanamg2007@yahoo.com   
Contact: Fawzi Abuhijla, MD, MSc    0777648881    FHijle@khcc.jo   
Sub-Investigator: Reema F Tayyem, Prof. Dr         
Sub-Investigator: Mohammed Isam Yamani, Prof. Dr         
Sponsors and Collaborators
University of Jordan
King Hussein Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Reema F Tayyem, Pro.Dr. University of Jordan
Principal Investigator: Mohammed Isam Yamani, Pro.Dr University of Jordan

Publications:
Abdollahi, H., Shiri, I., Atashzar, M., Sarebani, M., Moloudi, K., and Samadian, H. (2015), Radiation protection and secondary cancer prevention using biological radioprotectors in radiotherapy. International Journal of Cancer Therapy and Oncology, 3(3).

Layout table for additonal information
Responsible Party: Lana M. Agraib, PhD student, University of Jordan
ClinicalTrials.gov Identifier: NCT03742596     History of Changes
Other Study ID Numbers: 18 KHCC 65
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The center (KHCC) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lana M. Agraib, University of Jordan:
Colorectal cancer
Radiotherapy
immune system
Inflammatory markers
Life quality
Additional relevant MeSH terms:
Layout table for MeSH terms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms