Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000792527
Ethics application status
Approved
Date submitted
8/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the microbiome with prebiotics during cancer treatment- acute leukemia
Scientific title
Feasibility of prebiotic fibre supplementation during treatment for acute leukemia, a pilot randomised control trial in patients with newly diagnosed acute leukemia
Secondary ID [1] 312304 0
nil
Universal Trial Number (UTN)
Trial acronym
IMPaCT Leukemia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
haematological cancer 334048 0
acute leukemia 334049 0
Condition category
Condition code
Blood 330719 330719 0 0
Haematological diseases
Cancer 330720 330720 0 0
Leukaemia - Acute leukaemia
Diet and Nutrition 330721 330721 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial evaluates feasibility of an oral prebiotic fibre supplement during treatment for acute leukemia and the impact on clinical outcomes, the microbiome and immune function. The trial will take place on the haematology unit at the Royal Brisbane and Women's Hospital. The trial compares oral prebiotic supplementation (group 1) to standard care (group 2).

Group 1 will commence an oral prebiotic fibre supplement from the start of induction treatment after diagnosis and continue until the end of consolidation chemotherapy. The supplement will be provided for 3-6 months depending on number of consolidation cycles required. The prebiotic is a powdered fibre supplement mix of inulin, resistant starch and psyllium, split into two doses. Two sachets per day will provide a combined dose of 22g fibre per day. Participants will be advised to take the supplement with a meal and to commence 1 sachet per day for the first 3 days then increase to 2 sachets per day. Adherence will be measured by patients reporting consumption fortnightly (number of sachets provided compared to number remaining each fortnight and whether full sachets were consumed).
Intervention code [1] 328777 0
Treatment: Other
Comparator / control treatment
Group 2 will receive standard care with no fibre supplementation. There will be no difference in nutrition care or medical treatment between groups.
Control group
Active

Outcomes
Primary outcome [1] 338480 0
Feasibility of prebiotic fibre supplementation, defined as patients consuming >80% of the prescribed supplement over the study period.
Timepoint [1] 338480 0
Every week during induction treatment then every two weeks during the remaining supplementation period.
Secondary outcome [1] 436079 0
Patient acceptability of the oral prebiotic supplement
Timepoint [1] 436079 0
At the end of induction treatment and at the end of second consolidation treatment.
Secondary outcome [2] 436080 0
Incidence of infections
Timepoint [2] 436080 0
Collected continuously from study commencement to the end of the supplementation period.
Secondary outcome [3] 436081 0
Length of hospital stay (days)
Timepoint [3] 436081 0
At hospital discharge after induction treatment.
Secondary outcome [4] 436082 0
Unplanned hospital admissions
Timepoint [4] 436082 0
At the end of second consolidation treatment
Secondary outcome [5] 436083 0
Disease relapse
Timepoint [5] 436083 0
End of study (end of acute leukemia treatment for each patient, either end of consolidation treatment or post stem cell transplantation)
Secondary outcome [6] 436084 0
Nutritional status
Timepoint [6] 436084 0
Baseline, end of induction treatment and end of second consolidation treatment.
Secondary outcome [7] 436085 0
Dietary intake
Timepoint [7] 436085 0
At baseline, end of induction treatment, end of second consolidation treatment, and end of all consolidation (for patients having more than 2 cycles).
Secondary outcome [8] 436086 0
Gastrointestinal symptoms
Timepoint [8] 436086 0
Baseline, weekly during induction treatment and end of second consolidation treatment,
Secondary outcome [9] 436087 0
Quality of life
Timepoint [9] 436087 0
Baseline, end of induction treatment, end of second consolidation treatment.
Secondary outcome [10] 436095 0
Survival
Timepoint [10] 436095 0
End of induction treatment, end of second consolidation and end of treatment for acute leukemia.

Eligibility
Key inclusion criteria
• age 18 years or older
• newly diagnosed acute leukemia or myelodysplasia undergoing high intensity
intravenous induction chemotherapy at the Royal Brisbane and Women’s Hospital
(RBWH)
• ability to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• inflammatory bowel disease
• formal diagnosis of irritable bowel syndrome
• gastrointestinal resection
• ileostomy or colostomy
• any bariatric surgery including gastric bypass surgery, sleeve gastrectomy and gastric
band
• a contraindication to a high fibre diet (e.g. active diverticulitis or bowel obstruction)
• allergy/ intolerance to any ingredient in the fibre supplement
• current and planned ongoing consumption of probiotic or prebiotic supplement
• hepatitis B, hepatitis C or HIV infection unless viral load negative
• on carbamazepine
• inability to provide written informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The investigator recruiting participants will be unable to see which group they will be allocated to until after recruitment when the randomisation will be completed in REDCap. In REDCap future allocations are concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to study commencement, a randomisation table created by computer software will be entered into the REDCap database by an investigator not involved in recruitment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
30/03/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316696 0
Other
Name [1] 316696 0
Gateway for Cancer Research
Country [1] 316696 0
United States of America
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 318897 0
None
Name [1] 318897 0
Address [1] 318897 0
Country [1] 318897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315476 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 315476 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 315476 0
Australia
Date submitted for ethics approval [1] 315476 0
26/02/2024
Approval date [1] 315476 0
22/04/2024
Ethics approval number [1] 315476 0

Summary
Brief summary
This pilot study is evaluating the feasibility of providing an oral prebiotic fibre supplement during treatment for acute leukemia. It will assess tolerance and whether prebiotic supplementation can improve the microbiome and reduce complications.

Patients may be eligible to join this study if they are aged 18 years and older undergoing treatment for acute leukemia at the Royal Brisbane and Women’s Hospital (RBWH).

Participants in this study will be randomly allocated to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from the start of induction treatment until the end of their consolidation treatment. The control group will receive usual care.

It is hoped that prebiotic supplementation will support the microbiome and improve health outcomes for participants undergoing acute leukemia treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134810 0
Dr Sarah Andersen
Address 134810 0
Dietetics and Foodservices, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield St, Herston, QLD, 4029
Country 134810 0
Australia
Phone 134810 0
+61 7 36468268
Fax 134810 0
Email 134810 0
sarah.andersen@health.qld.gov.au
Contact person for public queries
Name 134811 0
Sarah Andersen
Address 134811 0
Dietetics and Foodservices, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield St, Herston, QLD, 4029
Country 134811 0
Australia
Phone 134811 0
+61 7 36468268
Fax 134811 0
Email 134811 0
sarah.andersen@health.qld.gov.au
Contact person for scientific queries
Name 134812 0
Sarah Andersen
Address 134812 0
Dietetics and Foodservices, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield St, Herston, QLD, 4029
Country 134812 0
Australia
Phone 134812 0
+61 7 36468268
Fax 134812 0
Email 134812 0
sarah.andersen@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.