Condition category
Cancer
Date applied
31/10/2019
Date assigned
09/11/2019
Last edited
08/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

08/11/2019: Trial's existence confirmed by ethics committee.