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Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal Cancer Patients

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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

Tracking Information
First Submitted Date  ICMJE November 11, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE November 7, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03742596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • 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 ".
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 15, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: November 14, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • The level of Carcinoembryonic antigen (CEA) [ Time Frame: Through study completion, an average of 1 yea ]
    The CEA in ng/ml at both baseline and end line of intervention
 
Descriptive Information
Brief Title  ICMJE Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal Cancer Patients
Official Title  ICMJE Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy on the Immune System Among Colorectal Cancer Patients
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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Probiotic Formula Capsule
  • 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.
    Intervention: Drug: Placebos
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lana M Agraib, MSc 00692795152669 lanamg2007@yahoo.com
Contact: Fawzi Abuhijla, MD,MSc 0069277764888 FHijle@khcc.jo
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742596
Other Study ID Numbers  ICMJE 18 KHCC 65
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The center (KHCC) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
Responsible Party Lana M. Agraib, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE King Hussein Cancer Center
Investigators  ICMJE
Principal Investigator: Reema F Tayyem, Pro.Dr. University of Jordan
Principal Investigator: Mohammed Isam Yamani, Pro.Dr University of Jordan
PRS Account University of Jordan
Verification Date June 2019

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