Benefit of prebiotic in reducing loose motions among cancer patients experiencing radiotherapy

ISRCTN ISRCTN17271186
DOI https://doi.org/10.1186/ISRCTN17271186
Secondary identifying numbers NMRR-14-1501-23172 (IIR)
Submission date
31/10/2019
Registration date
09/11/2019
Last edited
04/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Radical radiation therapy is commonly used for the treatment of pelvic cancers. The most common acute side effect of radiation is diarrhea, which can affect up to 80% of patients treated. One of the clinical complications that occurs following an inflammatory response to irradiation is a modification of the intestinal microflora. Gastrointestinal symptoms usually begin the second week of treatment and can lead to other problems such as malnutrition, abdominal pain, fecal incontinence, tenesmus, dehydration, weakness, reduced quality of life, increased cost of care, and delayed treatment completion. The aim of this study is to find out whether partially hydrolysed guar gum (PHGG) can reduce diarrhea occurence among cancer patients undergoing pelvic radiation.

Who can participate?
Cancer patients with pelvic cancers scheduled for external beam radiotherapy (EBRT) treatment

What does the study involve?
Participants are randomly allocated to receive either 10 g PHGG twice daily or 10 g maltodextrin (placebo) twice daily. Duration of supplementation is 28 days: 14 days before radiation and 14 days during treatment. Participation involves body measurements (weight, height and mid upper arm circumference), blood pressure, temperature and heart rate measurements, collection of blood and stool samples, and symptoms charting.

What are the possible benefits and risks of participating?
Participants will know their current body measurements, vital signs, liver profile, renal profile, full blood count level and dietary intake. Information from this study will have an important bearing on health policy as guidelines for dietary treatment of pelvic radiation among cancer patients undergoing pelvic radiotherapy in the Ministry of Health. Selected participants will undergo the standard procedure similar to the current practice by the Ministry of Health. Therefore, there will be minimal risk in taking part in this study.

Where is the study run from?
Hospital Sultan Ismail Johor Bahru (Malaysia)

When is the study starting and how long is it expected to run for?
April 2015 to April 2016

Who is funding the study?
Bio Scenergy Sdn Bhd

Who is the main contact?
Prof. Suzana Shahar
suzana.shahar@ukm.edu.my

Contact information

Prof Suzana Shahar
Scientific

Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia

Phone +603 (0)9289 7602
Email suzana.shahar@ukm.edu.my

Study information

Study designDouble-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEfficacy of partially hydrolysed guar gum (PHGG) in reducing risk of diarrhea among cancer patient undergoing pelvic radiation
Study objectivesDoes PHGG can reduce diarrhea occurence among cancer patient undergoing pelvic radiation?
Ethics approval(s)Approved 08/04/2015, Medical Research Ethics Committee (MREC)/MOH Research Grants (MRG) / Publication NIH Secretariat (Ministry of Health Malaysia, c/o Institute for Health Management, Block A, Kompleks Institut Kesihatan Negara (NIH), No 1 Jalan Setia Murni U13/52, Seksyen U13 Bandar Setia Alam, 40170 Shah Alam, Malaysia; Tel: +603 (0)3-3362 8888/8205; Email: nihsec@moh.gov.my), ref: NMRR-14-1501-23172 (IIR)
Health condition(s) or problem(s) studiedCancer patient (endometrium, cervix, colon, rectum and prostate) undergoing pelvic radiation treatment
InterventionEligible patients were allocated randomly (Random Allocation Software Ver 1.0 May 2004) to receive either 10 g twice daily PHGG or 10 g twice daily maltodextrin (placebo). Duration of supplementation was 28 days, e.g. 14 days pre radiation and 14 days during treatment.
Intervention typeSupplement
Primary outcome measureMeasured at baseline, day 7 (for microbiome growth only), day 14, day 28 and day 45:
1. Diarrhea incidence and frequency classified according to the National Cancer Institute Common Terminology Criteria (NCI-CTC); a reference of cancer patient’s managements Ministry of Health Malaysia 2017 (MOH Systemic Therapy Protocol 2016)
2. Stool formations recorded daily by patients based on Bristol Stool Charts
Secondary outcome measuresMeasured at baseline, day 7 (for microbiome growth only), day 14, day 28 and day 45:
1. Patient's self-collected fecal samples preserved in Stool Nucleic Acid Collection and Transport Tubes (Norgen, Canada) at 4°C until further processing. Fecal DNA extracted using Stool DNA Extraction kit (Qiagen, Germany). DNA samples assessed for their quality and quantity using NanoDrop Spectrophotometer (Thermo Scientific, UK). DNA samples stored at -20°C until further use.
2. Quantification of Bifidobacterium spp. and all bacteria cells based on copy number of 16s rDNA region performed using probe-based qPCR assay by 1st Base Laboratories Sdn Bhd (604944-X). All reactions performed in a 25 μL reaction system of (Thermo Scientific™ Maxima Probe qPCR Master Mix (2X)
3. Comprehensive nutritional status assessed using Scored Patient-Generated Subjective Global Assessment (PG-SGA)
4. Quality of Life (QoL) assessed using EORTC QLQ-C30 version 3.0 questionnaire
Overall study start date08/04/2015
Completion date08/04/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Total final enrolment30
Key inclusion criteriaCancer patient with pelvic cancers scheduled for external beam radiotherapy (EBRT) treatment as an outpatient or inpatient with EBRT dose 40 Gray and above, 180-220 cGy per fraction
Key exclusion criteriaPatients receiving enteral or parenteral nutrition or terminally ill
Date of first enrolment30/05/2015
Date of final enrolment30/12/2015

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Hospital Sultan Ismail Johor Bahru
Jalan Mutiara Emas Utama, Taman Mount Austin
Johor Bahru
81100
Malaysia

Sponsor information

Bio Scenergy Sdn Bhd
Industry

19C, Jalan TK1/11A, Taman Kinrara
Selangor
47180
Malaysia

Phone +603 (0)8070 9918
Email info@bioscenergy.com

Funders

Funder type

Industry

Bio Scenergy Sdn Bhd

No information available

Results and Publications

Intention to publish date12/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planProtocol available in Bahasa Melayu format. Primary and secondary outcome (bifidobacterium growth) to be published in 2021.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dzairudzee Rosli (dzai8558@gmail.com). Data obtained from the subject of the survey form is recorded and stored in accordance with the procedure of recording data by local law (Ministry of Health Malaysia). Archiving data is confidential and will be kept from unauthorized parties. Data and documents used throughout the study retained until five years after the study ended.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2021 04/08/2020 Yes No

Editorial Notes

04/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
08/11/2019: Trial's existence confirmed by ethics committee.