Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000525886
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
5/05/2021
Date last updated
5/05/2021
Date data sharing statement initially provided
5/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary counselling to increase soluble fibre in patients with gynaecological cancers undergoing pelvic radiotherapy: a feasibility study
Scientific title
Dietary counselling to increase soluble fibre in patients with gynaecological cancers undergoing pelvic radiotherapy: a feasibility study
Secondary ID [1] 303602 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecology Cancer 320976 0
Diarrhoea secondary to pelvic radiotherapy 320977 0
Condition category
Condition code
Cancer 318784 318784 0 0
Cervical (cervix)
Cancer 318785 318785 0 0
Ovarian and primary peritoneal
Cancer 318786 318786 0 0
Womb (Uterine or endometrial cancer)
Oral and Gastrointestinal 319533 319533 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are some potential benefits recently demonstrated with a high fibre intervention in improving gastrointestinal symptoms in patients with gynaecological cancers secondary to pelvic radiation treatment. Before further investigation into fibre as a therapeutic agent is undertaken, it must first be determined if increasing fibre intake will adversely affect radiation treatment delivery, as it is anticipated there will be an increase in gas production, which may affect bowel positioning. Hence, this study will look at whether an increased dietary fibre intervention is feasible in this population group without significantly affecting treatment fields and administration. Nutrition counselling and education by the research dietitian will be provided weekly via 30-45 minute one-on-one telehealth appointments throughout their radiation treatment to ensure the target fibre intake is achieved/maintained during this period. The initial session will involve:
- An assessment of their nutritional status (weight and PG-SGA)
- 24-diet recall to assess their total current dietary fibre intake and soluble fibre intake at baseline.
- Education of dietary fibre – overview of types of fibre (soluble and insoluble) and their function; common food sources; use of educational resources of which includes a ready reckoner, sourced from the Fibre Categories Database (Fuller et al., 2018), listing common foods and their fibre composition that participants can refer to when recording their soluble fibre intake in the food diaries provided.
- Develop (in liaison with the dietitian) a personalized meal plan/suggestions and strategies to gradually increase or modify dietary fibre intake, depending on baseline intake of dietary fibre (to avoid intolerance issues)
- Demonstration of how to accurately record intake using a 3-day food diary (template designed specifically for this study and provided to participants)
- Provision of contact details of the treating dietitian should they require additional support. Participants will be made aware that they are permitted to access dietetic services as much as required. Total time with dietitian will be recorded and documented for each participant.
Weekly review sessions will include:
- Assessment of their adherence via completion of the 3-day diet diaries
- Weekly weights
- Nutrition counselling and education to ensure the target fibre intake is reached and maintained each week throughout treatment
- Nutritional counselling to ensure maintenance of nutritional status and to manage any other nutrition-impact symptoms from treatment.

The intervention will be individualised to account for variation in baseline dietary soluble fibre intake between individuals and to mitigate excess gas being produced as a result of significantly increasing fibre consumption in a short period of time. Once the baseline fibre intake is assessed for each individual upon commencement of the intervention, the study dietitian will assist in developing a meal plan in collaboration with the participant to increase their soluble fibre intake by 2-3g each week during radiation treatment.
Preliminary data will also be collected to look at the effect of an increased dietary (soluble) fibre diet on radiation-induced diarrhoea, nutritional status and quality of life. This will be a single arm single centre intervention feasibility trial, recruiting 40 participants from the RBWH radiation oncology outpatient department. Results from this study will determine whether increasing dietary fibre is realistic and safe to achieve in this setting, precluding any adverse effect on radiation treatment delivery.
Intervention code [1] 319892 0
Treatment: Other
Intervention code [2] 320189 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326728 0
Adherence (70%) as per screen fail rates determined by audit of study database.
Timepoint [1] 326728 0
Upon commencement of intervention and during (i.e. weekly throughout radiation treatment), with the primary endpoint being at the end of the last week of radiation treatment,
Primary outcome [2] 327094 0
Adherence (70%) as per proportion of participants adhering (defined as achieving 80% of goal) to dietary intervention assessed using 3-day food diary (designed specifically for this study).
Timepoint [2] 327094 0
Upon commencement of intervention and during (i.e. weekly throughout radiation treatment), with the primary endpoint being at the end of the last week of radiation treatment,
Secondary outcome [1] 392487 0
Rate of adverse events affecting radiation treatment delivery as measured by:
-Qualitative evaluation using a visual analog scale (developed for this study) of pre-treatment cone-beam CT (CBCT) scan compared to baseline CT scan performed at weekly intervals throughout radiation treatment - noting changes in gas production, bowel filling and acceptability for treatment or requiring alterations to treatment plan
Timepoint [1] 392487 0
Weekly throughout radiation treatment.
Secondary outcome [2] 392488 0
Proportion of patients with GI toxicity symptoms, particularly diarrhoea as measured by the:
a. IBD-Q32 (Modified Inflammatory bowel disease questionnaire)
Timepoint [2] 392488 0
Upon commencement of radiation treatment and weekly during treatment until end of radiation treatment.


Secondary outcome [3] 392489 0
Changes in nutrition status as measured by the:
-PG-SGA (Patient generated- subjective global assessment)
Timepoint [3] 392489 0
-Upon commencement of radiation treatment and end of radiation treatment for nutrition status.
-Weekly throughout radiation treatment for weight measurements.
Secondary outcome [4] 392490 0
Changes in Quality of Life as measured by the:
- EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer quality of life questionnaire) & subsets specific to diagnosis
Timepoint [4] 392490 0
Upon commencement of radiation treatment and end of radiation treatment.
Secondary outcome [5] 393766 0
Changes in weight - assessed using digital standing scale,
Timepoint [5] 393766 0
Upon commencement of radiation treatment, weekly during treatment until end of radiation treatment.
Secondary outcome [6] 393767 0
Proportion of patients with GI toxicity symptoms, particularly diarrhoea as measured by the:
b. Stool diary including the Bristol stool chart (stool consistency/ stool form and frequency/ output)
Timepoint [6] 393767 0
Upon commencement of radiation treatment, weekly during treatment until end of radiation treatment.
Secondary outcome [7] 393768 0
Proportion of patients with GI toxicity symptoms, particularly diarrhoea as measured by the:
c. PRO-CTCAE Grading (gas, bloating, constipation, diarrhoea, abdominal pain, faecal incontinence)
Timepoint [7] 393768 0
Upon commencement of radiation treatment, weekly during treatment until end of radiation treatment.

Eligibility
Key inclusion criteria
1. Female diagnosed with gynaecological cancer attending the Royal Brisbane and Women’s Hospital (RBWH) for definitive or adjuvant pelvic radiotherapy- with curative intent (may or may not be undergoing sequential or concurrent chemotherapy).
2. Aged 18 years or older
3. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
4. Able to provide signed, written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients undergoing palliative-intent treatment
2. Patients undergoing extended field radiation treatment or has completed previous pelvic radiotherapy
3. Involvement in any other clinical trials and/or on immunotherapy
4. Other GI disease - i.e. Crohn’s disease, ulcerative colitis, bowel inflammation, irritable bowel syndrome (IBS), diverticulitis, high risk of small bowel obstruction
5. Cognitive function impairment
6. Inability to speak/ understand English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size: ~40
Sample size calculation: One arm binomial (Type 1 error/ alpha 0.05) (Power 80%) - one sided test - null proportion 50%; alternative proportion 70%
=37 participants required

Descriptive statistics will be used to describe adverse events affecting radiation treatment delivery, GI toxicity symptoms, nutrition status and quality of life pre- and post-radiation treatment completion.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/05/2021
Actual
Date of last participant enrolment
Anticipated
5/04/2022
Actual
Date of last data collection
Anticipated
20/05/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18852 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 33353 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 308022 0
University
Name [1] 308022 0
University of Queensland
Country [1] 308022 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Level 2, Connell Building
School of Human Movement and Nutrition Sciences
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 309073 0
None
Name [1] 309073 0
Address [1] 309073 0
Country [1] 309073 0
Other collaborator category [1] 281680 0
Hospital
Name [1] 281680 0
Royal Brisbane and Women's Hospital
Address [1] 281680 0
Butterfield St, Herston QLD 4029
Country [1] 281680 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308012 0
The Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC) (EC00172)
Ethics committee address [1] 308012 0
Ethics committee country [1] 308012 0
Australia
Date submitted for ethics approval [1] 308012 0
30/11/2020
Approval date [1] 308012 0
03/02/2021
Ethics approval number [1] 308012 0
HREC/2021/QRBW/70042
Ethics committee name [2] 308019 0
Research Ethics and Integrity The University of Queensland
Ethics committee address [2] 308019 0
Ethics committee country [2] 308019 0
Australia
Date submitted for ethics approval [2] 308019 0
19/02/2021
Approval date [2] 308019 0
23/02/2021
Ethics approval number [2] 308019 0
2021/HE000163

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109230 0
Miss Emilie Croisier
Address 109230 0
Level 2, Connell Building
School of Human Movement and Nutrition Sciences University of Queensland St Lucia
QLD 4072
Country 109230 0
Australia
Phone 109230 0
+61 7 3365 6313
Fax 109230 0
Email 109230 0
[email protected]
Contact person for public queries
Name 109231 0
Emilie Croisier
Address 109231 0
Level 2, Connell Building
School of Human Movement and Nutrition Sciences University of Queensland St Lucia
QLD 4072
Country 109231 0
Australia
Phone 109231 0
+61 7 3365 6313
Fax 109231 0
Email 109231 0
[email protected]
Contact person for scientific queries
Name 109232 0
Emilie Croisier
Address 109232 0
Level 2, Connell Building
School of Human Movement and Nutrition Sciences University of Queensland St Lucia
QLD 4072
Country 109232 0
Australia
Phone 109232 0
+61 7 3365 6313
Fax 109232 0
Email 109232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All individual participant data collected and de-identified during the trial will not be shared to members outside of the research team. Analysis of results will be completed by the principal investigator of the study. The findings will collectively be published in a journal and shared at relevant conferences.


What supporting documents are/will be available?




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.