NCT03742596

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

Withdrawn Phase 2, PHASE3 Last updated 15 March 2023

What this trial tests

Phase 2, PHASE3 trial testing Probiotic Formula Capsule in Colorectal Cancer. Withdrawn.

Timeline

7 November 2018

Primary endpoint
30 September 2022

30 December 2022

Quick facts

Lead sponsor	King Hussein Cancer Center
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Start date	7 November 2018
Primary completion	30 September 2022
Estimated completion	30 December 2022
Sites	1 location across Jordan

Drugs / interventions tested

• Probiotic Formula Capsule — full drug profile →
• Control

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

King Hussein Cancer Center — full company profile →

Who can join

Adults 35 to 65, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut microbiota modulation: a novel strategy for prevention and treatment of colorectal cancer.
   Fong W, Li Q, Yu J. · · 2020 · cited 411× · PMID 32514151 · DOI 10.1038/s41388-020-1341-1
2. Modulating the microbiome to improve therapeutic response in cancer.
   McQuade JL, Daniel CR, Helmink BA, Wargo JA. · · 2019 · cited 283× · PMID 30712808 · DOI 10.1016/s1470-2045(18)30952-5
3. Gut Microbiota in Colorectal Cancer: Biological Role and Therapeutic Opportunities.
   Pandey H, Tang DWT, Wong SH, Lal D. · · 2023 · cited 86× · PMID 36765824 · DOI 10.3390/cancers15030866
4. Impact of the microbiome on cancer progression and response to anti-cancer therapies.
   Buchta Rosean C, Feng TY, Azar FN, Rutkowski MR. · · 2019 · cited 32× · PMID 31202360 · DOI 10.1016/bs.acr.2019.03.005
5. Bacteria and Bacterial Components as Natural Bio-Nanocarriers for Drug and Gene Delivery Systems in Cancer Therapy.
   Zong R, Ruan H, Liu C, Fan S, et al · · 2023 · cited 19× · PMID 37896250 · DOI 10.3390/pharmaceutics15102490
6. Targeting gut microbiota and metabolites in cancer radiotherapy.
   Ma S, Li X, Shang S, Zhai Z, et al · · 2025 · cited 3× · PMID 41028942 · DOI 10.1002/ctm2.70481
7. Gut microbes and their metabolites in relation to the classic tumor suppressor gene P53: a novel narrative.
   Li JX, Liu CG, Chen J. · · 2025 · cited 3× · PMID 40675970 · DOI 10.1038/s41522-025-00775-x