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

NCT03742596 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 19 KHCC 111
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Radiotherapy; immune system; Inflammatory markers; Life quality

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (2)

• Quality of Life of patients

  Through study completion, an average of 1 year

• The gastrointestinal toxicity

  Through study completion, an average of 1 year

Other Outcomes (13)

• The level of White blood cell count (WBC)

  Through study completion, an average of 1 yea

• The level of red blood cell count (RBC)

  Through study completion, an average of 1 yea

• The mean corpuscular volume (MCV)

  Through study completion, an average of 1 yea

Study Arms (2)

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

Dietary Supplement: Probiotic Formula Capsule

Control

OTHER

In this intervention arm, the control arm will receive normal treatment without any probiotic

Drug: Control

Interventions

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.

Also known as: Treatment

Probiotic Formula Capsule

Control DRUG

The Placebos will be coded in a specific label by a researcher.

Control

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women,
• Aged from 35- 65 years with histologically proven CRC and
• Histologically proven CRC with stage I, II, III
• 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.

You may not qualify if:

• Active infection treated by antibiotic therapy or recent infection or recent antibiotic use;
• Severe cardiovascular and cerebrovascular diseases that could not tolerate radical surgery;
• Recent use of probiotics, prebiotics, or synbiotic;
• Evidence of immunodeficiency;
• Cancer stage IV
• Pregnancy,
• Recent/concurrent admission to ER
• 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.

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, Jordan

Location

Related Publications (10)

• 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.

  PMID: 19640788 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.

  PMID: 24607309 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).

  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.

  PMID: 27048903 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.

  PMID: 17881902 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.

  PMID: 27151581 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.

  PMID: 25872116 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.

  PMID: 23271629 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.

  PMID: 27923508 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.

  PMID: 22830611 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Fawzi Abuhijla, MD,MSc

  King Hussein Cancer Center

  PRINCIPAL INVESTIGATOR

• Lana M Agraib, PhD

  University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Radiation Oncologist

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 15, 2018
• Study Start: November 7, 2018
• Primary Completion: September 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)