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

NCT03742596 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-03-15

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probiotic Formula Capsule

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.

DRUG

Control

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

Sponsors & Collaborators

  • King Hussein Cancer Center

    lead OTHER

Principal Investigators

  • Fawzi Abuhijla, MD,MSc · King Hussein Cancer Center

  • Lana M Agraib, PhD · University of Jordan

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2022-09-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742596 on ClinicalTrials.gov