Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001172695
Ethics application status
Approved
Date submitted
23/01/2023
Date registered
14/11/2023
Date last updated
14/11/2023
Date data sharing statement initially provided
14/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
HYPO-BL: Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial –
Ultra versus Moderate Breast Hypofractionation Radiation Treatment
Scientific title
Breast Lymphoedema and Radiation Treatment Randomised Controlled Trial –
Ultra versus Moderate Breast Hypofractionation Radiation Treatment (HYPO-BL)
Secondary ID [1] 308795 0
None
Universal Trial Number (UTN)
Trial acronym
HYPO-BL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Lymphoedema in Breast cancer patients receiving radiotherapy 328743 0
Breast Cancer 328744 0
Condition category
Condition code
Cancer 325748 325748 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is enrolling 200 patients.
If the patient meets the inclusion criteria of the study as per radiation oncologist they can be randomised onto the study via an electronic system.

There is a 50/50 chance of being randomised into either arm of the study. Radiotherapy treatment could either be 5-9 or 15-19 days.

In the shorter course arm, patients will receive radiotherapy delivered by radiation therapists at Gosford Hospital at a dose of 26.0Gy in five fractions with an optional tumour bed boost (This optional boost is decided by the Radiation Oncologist).

This tumour bed boost can be given simultaneously as 30Gy in five fractions or sequentially as 10Gy in four fractions.


The overall duration of the intervention is over 5-9 days.
Intervention code [1] 325247 0
Treatment: Other
Comparator / control treatment
In the longer course arm, patients will receive radiotherapy delivered by radiation therapists at Gosford Hospital at a dose of 40.05Gy in 15 fractions daily with an optional tumour bed boost (This optional boost is decided by the Radiation Oncologist) .

This tumour bed boost is given given simultaneously as 45.75Gy in fifteen fractions or sequentially as 10Gy in four fractions.

The overall duration of the intervention is over 15-19 days.
Control group
Active

Outcomes
Primary outcome [1] 333599 0
To determine the incidence of breast oedema when treating with a moderately hypofractionated radiation schedule compared to an accelerated ultra-hypofractionated schedule. Breast oedema defined as Tissue dielectric constant (TDC) ratio greater than or equal to 1..40.
Timepoint [1] 333599 0
Whole breast TDC ratio based on measurements prior to commencing radiotherapy, then at 3, 6, 12 and 24 months after breast radiotherapy
Secondary outcome [1] 417696 0
To determine the longitudinal incidence of breast oedema based on Tissue dielectric constant (TDC) ratio,
Timepoint [1] 417696 0
Timepoints for measurement are at baseline prior to radiotherapy, 3, 6, 12, and 24 months after radiotherapy.
Secondary outcome [2] 419068 0
Clinician-reported outcomes (CRO) - composite outcome.
Rates of moderate and marked clinician-reported outcomes using the IMPORT-LOW protocol specific questionnaire items. A four-point scale of none, a little, quite a bit, very much will be interpreted as none, mild, moderate, marked.
Timepoint [2] 419068 0
CRO questionnaire items will be completed at baseline prior to radiotherapy, 3, 6, 12, and 24 months after radiotherapy.
Secondary outcome [3] 419289 0
Rates of moderate and marked patient-reported outcomes using the EORTC QLQ-BR45 questions related to breast and body image. A four-point scale of none, a little, quite a bit, very much, which will be interpreted as none, mild, moderate, marked.
The patient questionnaires will be sent electronically to the patient (via text or email). If this is not possible then they will be completed during clinic visits.
Timepoint [3] 419289 0
Timepoints for measurement are at baseline prior to radiotherapy, 3, 6, 12, 24 and 60 months after radiotherapy.
Secondary outcome [4] 425445 0
Rates of moderate and marked patient-reported outcomes using BCTOS-22.
A four-point scale of none, slight, moderate, large, which will be interpreted as none, mild, moderate, marked.
The patient questionnaires will be sent electronically to the patient (via text or email). If this is not possible then they will be completed during clinic visits.
Timepoint [4] 425445 0
Timepoints for measurement are at baseline prior to radiotherapy, 3, 6, 12, 24 and 60 months after radiotherapy.
Secondary outcome [5] 425446 0
A protocol-specific PRO questionnaire related to post-radiotherapy breast changes will be assessed using a four-point scale of none, a little, quite a bit, very much, which will be interpreted as none, mild, moderate, marked.
The patient questionnaires will be sent electronically to the patient (via text or email). If this is not possible then they will be completed during clinic visits.
Timepoint [5] 425446 0
Timepoints for measurement are at baseline prior to radiotherapy, 3, 6, 12, 24 and 60 months after radiotherapy

Eligibility
Key inclusion criteria
1.Women aged 50 years or older
2. Unilateral DCIS or early-stage invasive breast cancer (Stage Tis-T3, N0, M0)
3. Breast conservation surgery
4. Complete microscopic resection i.e. negative margins
5. Neoadjuvant systemic therapy to downstage cT3-T4 breast cancer is accepted if there is not an indication to irradiate the lymph nodes or treat with bolus
6. Ability to understand and willingness to sign written informed consent
7. Available for 2 years of face-to face follow-up
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior history of breast cancer or DCIS
2. Bilateral breast cancer or bilateral breast surgery (e.g. symmetrising surgery)
3. History of breast implants or breast reconstructive surgery in either breast
4. Use of bolus during radiotherapy
5. Prone breast radiation treatment
6. Conditions where the patient cannot complete radiation treatment or attend follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial e.g. language problems.
7. Unwilling or unable to give 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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2024
Actual
Date of last participant enrolment
Anticipated
2/01/2026
Actual
Date of last data collection
Anticipated
2/01/2033
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23856 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 39315 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 313011 0
Hospital
Name [1] 313011 0
Gosford Hospital
Country [1] 313011 0
Australia
Primary sponsor type
Hospital
Name
Gosford Hospital
Address
Central Coast Cancer Centre Radiation Oncology Gosford HospitalHolden Street Gosford NSW 2250
Country
Australia
Secondary sponsor category [1] 314700 0
None
Name [1] 314700 0
None
Address [1] 314700 0
None
Country [1] 314700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312274 0
Northern Sydney Local Health District
Ethics committee address [1] 312274 0
Ethics committee country [1] 312274 0
Australia
Date submitted for ethics approval [1] 312274 0
30/01/2023
Approval date [1] 312274 0
04/04/2023
Ethics approval number [1] 312274 0
2023/ETH00014

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

Contacts
Principal investigator
Name 124070 0
Dr Hester Lieng
Address 124070 0
Central Coast Cancer CentreGosford HospitalHolden St, Gosford, NSW 2250
Country 124070 0
Australia
Phone 124070 0
+61 2 4320 9813
Fax 124070 0
+61 2 4320 9789
Email 124070 0
hester.lieng@health.nsw.gov.au
Contact person for public queries
Name 124071 0
Michelle Dixon
Address 124071 0
Central Coast Cancer CentreGosford HospitalHolden St, Gosford, NSW 2250
Country 124071 0
Australia
Phone 124071 0
+61 2 4320 9854
Fax 124071 0
+61 2 4320 9789
Email 124071 0
michelle.dixon@health.nsw.gov.au
Contact person for scientific queries
Name 124072 0
Hester Lieng
Address 124072 0
Central Coast Cancer CentreGosford HospitalHolden St, Gosford, NSW 2250
Country 124072 0
Australia
Phone 124072 0
+61 2 4320 9888
Fax 124072 0
Email 124072 0
hester.lieng@health.nsw.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
data will not be shared and only for use at site


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.