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
suzana.shahar@ukm.edu.my
Trial website
Contact information
Type
Scientific
Primary contact
Prof Suzana Shahar
ORCID ID
Contact details
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
+603 (0)9289 7602
suzana.shahar@ukm.edu.my
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov 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
Acronym
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: nihsec@moh.gov.my), ref: NMRR-14-1501-23172 (IIR)
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Cancer patient (endometrium, cervix, colon, rectum and prostate) undergoing pelvic radiation treatment
Intervention
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
Supplement
Phase
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
08/04/2015
Overall trial end date
08/04/2016
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
Patients receiving enteral or parenteral nutrition or terminally ill
Recruitment start date
30/05/2015
Recruitment end date
30/12/2015
Locations
Countries of recruitment
Malaysia
Trial participating centre
Hospital Sultan Ismail Johor Bahru
Jalan Mutiara Emas Utama, Taman Mount Austin
Johor Bahru
81100
Malaysia
Sponsor information
Organisation
Bio Scenergy Sdn Bhd
Sponsor details
19C
Jalan TK1/11A
Taman Kinrara
Selangor
47180
Malaysia
+603 (0)8070 9918
info@bioscenergy.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bio Scenergy Sdn Bhd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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 (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.
Intention to publish date
12/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list