Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

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

Trial website

Contact information



Primary contact

Prof Suzana Shahar


Contact details

Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
+603 (0)9289 7602

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number

NMRR-14-1501-23172 (IIR)

Study information

Scientific title

Efficacy of partially hydrolysed guar gum (PHGG) in reducing risk of diarrhea among cancer patient undergoing pelvic radiation


Study hypothesis

Does PHGG can reduce diarrhea occurence among cancer patient undergoing pelvic radiation?

Ethics approval

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:, ref: NMRR-14-1501-23172 (IIR)

Study design

Double-blind randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Cancer patient (endometrium, cervix, colon, rectum and prostate) undergoing pelvic radiation treatment


Eligible 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 type



Drug names

Primary outcome measure

Measured 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 measures

Measured 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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Cancer 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

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

Patients receiving enteral or parenteral nutrition or terminally ill

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

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

Sponsor information


Bio Scenergy Sdn Bhd

Sponsor details

Jalan TK1/11A
Taman Kinrara
+603 (0)8070 9918

Sponsor type




Funder type


Funder name

Bio Scenergy Sdn Bhd

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Protocol available in Bahasa Melayu format. Primary and secondary outcome (bifidobacterium growth) to be published in 2021.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dzairudzee Rosli ( 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.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in (added 04/08/2020)

Publication citations

Additional files

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.