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Colorectal CancerPhase 2/3NCT03742596

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

A Phase 2/3 study testing Probiotic Formula Capsule in people with Colorectal Cancer, run by King Hussein Cancer Center at 1 site in Jordan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Probiotic Formula Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteJordan
Study dates
7 Nov 2018to 30 Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • King Hussein Cancer Center

    Amman

Other trials in Jordan

About this study

Official title: Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy on the Immune System Among Colorectal Cancer Patients

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.

Read the detailed description

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).

Being tested
Probiotic Formula Capsule, Control
Keywords
Colorectal cancer, Radiotherapy, immune system, Inflammatory markers, Life quality
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic Formula CapsuleDietary supplement

    Also called Treatment

    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.

  • ControlDrug

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

Study groups in NCT03742596
Study groupRoleWhat they receive
Probiotic Formula CapsuleExperimentalIn 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
Receives: Dietary Supplement: Probiotic Formula Capsule
ControlOtherIn this intervention arm, the control arm will receive normal treatment without any probiotic
Receives: Drug: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The level of Immunoglobulin (Ig) A

    The level of Immunoglobulin (Ig) A in g/L at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  2. The level of Immunoglobulin (Ig) G

    The level of Immunoglobulin (Ig) G in g/L at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  3. The level of Immunoglobulin (Ig) M

    The level of Immunoglobulin (Ig) M in g/L at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  4. The Level of Interleukin (IL)-6

    The Level of Interleukin (IL)-6 in pg/ml at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  5. The Level of Interleukin (IL)-1

    The Level of Interleukin (IL)-1 in pg/ml at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  6. The Level of Interleukin (IL)-10

    The Level of Interleukin (IL)-10 in pg/ml at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  7. The Level of Tumor Necrosis Factor (TNF)-α

    The Level of TNF-α in pg/ml at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 year

  8. The Level of C-reactive protein (CRP)

    The Level of CRP in mg/ml at both baseline and end line of intervention

    Measured: Through study completion, an average of 1 yea

Secondary outcomes (2)

  1. 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 ".

    Measured: Through study completion, an average of 1 year

  2. 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

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start7 Nov 2018
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Why it stopped: This study was closed without recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742596
Sponsor's protocol ID
19 KHCC 111
Status last verified
Mar 2023
First submitted
11 Nov 2018
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The center (KHCC) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data

Publications

  • 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.

    PubMed 19640788

  • 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.

    PubMed 24607309

  • 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).

  • 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.

    PubMed 27048903

  • 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.

    PubMed 17881902

  • 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.

    PubMed 27151581

  • 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.

    PubMed 25872116

  • 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.

    PubMed 23271629

  • 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.

    PubMed 27923508

  • 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.

    PubMed 22830611

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Probiotic Formula Capsule in people with Colorectal Cancer, run by King Hussein Cancer Center at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The level of Immunoglobulin (Ig) A (time frame: Through study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742596, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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