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This study was closed without recruitment
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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 assigned either to receive 3 times a day probiotic supplement or to be control with no intervention. 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 patients and other types of cancer to reduce the side effects of radiotherapy and raise body weight as well as improving their quality of life.
To meet the objectives of the study, a control group will be included in 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 and to take the drug will be allocated to the probiotic supplementation group, while patients who agree to participate but not to receive the drug will be allocated to the control group. The duration of the 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 that will be assigned to the probiotics group (n=20), to receive 3 times a day probiotic supplement. The duration of the intervention (administration of probiotics) will 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 the end of radiation therapy and 10-14 days after 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Formula Capsule | Experimental | 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 |
|
| Control | Other | In this intervention arm, the control arm will receive normal treatment without any probiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula Capsule | Dietary Supplement | The Probiotic will be coded in a specific label by a researcher. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 7 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The level of Immunoglobulin (Ig) A | The level of Immunoglobulin (Ig) A in g/L at both baseline and end line of intervention | Through study completion, an average of 1 year |
| The level of Immunoglobulin (Ig) G | The level of Immunoglobulin (Ig) G in g/L at both baseline and end line of intervention | Through study completion, an average of 1 year |
| The level of Immunoglobulin (Ig) M | The level of Immunoglobulin (Ig) M in g/L at both baseline and end line of intervention | Through study completion, an average of 1 year |
| The Level of Interleukin (IL)-6 | The Level of Interleukin (IL)-6 in pg/ml at both baseline and end line of intervention | Through study completion, an average of 1 year |
| The Level of Interleukin (IL)-1 | The Level of Interleukin (IL)-1 in pg/ml at both baseline and end line of intervention | Through study completion, an average of 1 year |
| The Level of Interleukin (IL)-10 | The Level of Interleukin (IL)-10 in pg/ml at both baseline and end line of intervention | Through study completion, an average of 1 year |
| The Level of Tumor Necrosis Factor (TNF)-α | The Level of TNF-α in pg/ml at both baseline and end line of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life of patients | 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 ". |
| Measure | Description | Time Frame |
|---|---|---|
| The level of White blood cell count (WBC) | he level of WBC as cells/ul at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The level of red blood cell count (RBC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fawzi Abuhijla, MD,MSc | King Hussein Cancer Center | Principal Investigator |
| Lana M Agraib, PhD | University of Jordan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Hussein Cancer Center | Amman | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19640788 | Background | Abayomi J, Kirwan J, Hackett A. The prevalence of chronic radiation enteritis following radiotherapy for cervical or endometrial cancer and its impact on quality of life. Eur J Oncol Nurs. 2009 Sep;13(4):262-7. doi: 10.1016/j.ejon.2009.02.007. Epub 2009 Jul 28. | |
| 24607309 | Background | Abdollahi H. Probiotic-based protection of normal tissues during radiotherapy. Nutrition. 2014 Apr;30(4):495-6. doi: 10.1016/j.nut.2013.09.006. No abstract available. |
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The center (KHCC) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Control | Drug | The Placebos will be coded in a specific label by a researcher. |
|
| Through study completion, an average of 1 year |
| The Level of C-reactive protein (CRP) | The Level of CRP in mg/ml at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| Through study completion, an average of 1 year |
| The gastrointestinal toxicity | 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 | Through study completion, an average of 1 year |
The level of RBC as cells/ul at both baseline and end line of intervention
| Through study completion, an average of 1 yea |
| The mean corpuscular volume (MCV) | The MCV in fl at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The mean corpuscular hemoglobin (MCH) | The MCH in pg at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The mean corpuscular hemoglobin concentration (MCHC) | The MCH in g/dl at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The Platelet count | The Platelet count as cells/ ul at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The of Hemoglobin | The Hemoglobin in g/dl at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The mean platelet volume (MPV) | The MPV in fl at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The level of lymphocytes | The number of lymphocytes cells at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The level of Monocytes | The number of Monocytes cells at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The level of eosinophils | The number of eosinophils cells at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The level of basophils | The number of basophils cells at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| The level of neutrophils | The number of neutrophils cells at both baseline and end line of intervention | Through study completion, an average of 1 yea |
| Background | 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). |
| 27048903 | Background | Ambalam P, Raman M, Purama RK, Doble M. Probiotics, prebiotics and colorectal cancer prevention. Best Pract Res Clin Gastroenterol. 2016 Feb;30(1):119-31. doi: 10.1016/j.bpg.2016.02.009. Epub 2016 Feb 19. |
| 17881902 | Background | Bowen JM, Stringer AM, Gibson RJ, Yeoh AS, Hannam S, Keefe DM. VSL#3 probiotic treatment reduces chemotherapy-induced diarrhea and weight loss. Cancer Biol Ther. 2007 Sep;6(9):1449-54. doi: 10.4161/cbt.6.9.4622. Epub 2007 Jun 23. |
| 27151581 | Background | Ciernikova S, Mego M, Semanova M, Wachsmannova L, Adamcikova Z, Stevurkova V, Drgona L, Zajac V. Probiotic Survey in Cancer Patients Treated in the Outpatient Department in a Comprehensive Cancer Center. Integr Cancer Ther. 2017 Jun;16(2):188-195. doi: 10.1177/1534735416643828. Epub 2016 May 5. |
| 25872116 | Background | Ciorba MA, Hallemeier CL, Stenson WF, Parikh PJ. Probiotics to prevent gastrointestinal toxicity from cancer therapy: an interpretive review and call to action. Curr Opin Support Palliat Care. 2015 Jun;9(2):157-62. doi: 10.1097/SPC.0000000000000134. |
| 23271629 | Background | Dai C, Zheng CQ, Meng FJ, Zhou Z, Sang LX, Jiang M. VSL#3 probiotics exerts the anti-inflammatory activity via PI3k/Akt and NF-kappaB pathway in rat model of DSS-induced colitis. Mol Cell Biochem. 2013 Feb;374(1-2):1-11. doi: 10.1007/s11010-012-1488-3. Epub 2012 Oct 23. |
| 27923508 | Background | Dasari S, Kathera C, Janardhan A, Praveen Kumar A, Viswanath B. Surfacing role of probiotics in cancer prophylaxis and therapy: A systematic review. Clin Nutr. 2017 Dec;36(6):1465-1472. doi: 10.1016/j.clnu.2016.11.017. Epub 2016 Nov 24. |
| 22830611 | Background | Escamilla J, Lane MA, Maitin V. Cell-free supernatants from probiotic Lactobacillus casei and Lactobacillus rhamnosus GG decrease colon cancer cell invasion in vitro. Nutr Cancer. 2012 Aug;64(6):871-8. doi: 10.1080/01635581.2012.700758. Epub 2012 Jul 25. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |