Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000342910
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
11/03/2020
Date last updated
13/07/2022
Date data sharing statement initially provided
11/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
BaROQUE: RCT - Breast Oedema: Quantify and Improve: Assessment and treatment of breast oedema in women following breast cancer treatment - A randomised controlled trial
Scientific title
BaROQUE: RCT - Breast Oedema: Quantify and Improve: Effect of treatment of breast oedema on self reported symptoms and objective measures in women following breast cancer treatment - A randomised controlled trial
Secondary ID [1] 298264 0
None
Universal Trial Number (UTN)
U111-1233-6411
Trial acronym
BaROQUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 312881 0
Lymphoedema - Breast 312882 0
Condition category
Condition code
Cancer 311373 311373 0 0
Breast
Cardiovascular 311374 311374 0 0
Diseases of the vasculature and circulation including the lymphatic system
Physical Medicine / Rehabilitation 311375 311375 0 0
Occupational therapy
Physical Medicine / Rehabilitation 311376 311376 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 hour long individual face to face treatment sessions will be completed twice per week for 3 weeks (6 sessions in total) at the Westmead Hospital Breast Cancer Institute. Treatment includes Manual lymphatic drainage which is a technique performed by a trained lymphoedema therapist to move fluid from the swollen area (breast/arm area) to an area that has normal lymphatic drainage. It involves the therapist applying very gentle pressure to the skin in slow rhythmic movements. Participants will also receive verbal and written instruction on caring for their skin (using moisturiser) and be provided with 2 compression bras to wear 12 hours daily for 3 weeks (Bellisse bra - Jobst). Women will be asked to complete a daily diary of how long they wore the bra for and any issues with comfort.
Intervention code [1] 316442 0
Treatment: Devices
Intervention code [2] 316443 0
Treatment: Other
Comparator / control treatment
Waitlist control group - Skin care and wearing of supportive bra for 21 days.
Women in the waitlist control group will commence intervention through a lymphoedema clinic/therapist of their choice following the final measures for the trial (i.e 3 weeks after the baseline measures).
Control group
Active

Outcomes
Primary outcome [1] 322740 0
Change in patient reported outcome measures (composite primary outcome).
Four patient reported questionnaires will be completed to ensure all symptoms/experiences of breast oedema are examined:
- European Organisation for Research and Treatment of Cancer Breast (EORTC) QLQ-BR23
- Lymphoedema Symptom Intensity and Distress Survey –midline (LSIDS-M)
- Breast Oedema Bother Scale (BOB).
- Breast Lymphoedema Severity Symptom (BLYSS) questionnaire
Timepoint [1] 322740 0
Baseline and end of treatment (3 weeks)
Those in the treatment arm will also be asked to complete the questionnaires at each treatment visit to assess for any fluctuations in symptoms with treatment.
Secondary outcome [1] 379507 0
Volume of extracellular fluid, assessed with bioimpedance spectroscopy
Timepoint [1] 379507 0
Baseline and end of treatment (3 weeks)
Secondary outcome [2] 379508 0
Dermal thickness assessed by ultrasound
Timepoint [2] 379508 0
Baseline and end of treatment (3 weeks)
Secondary outcome [3] 379509 0
Breast Volume assessed using 3D Surface imagery Photography (Vectra)
Timepoint [3] 379509 0
Baseline and end of treatment (3 weeks)
Secondary outcome [4] 380808 0
Dermal thickness assessed by mammogram
Timepoint [4] 380808 0
Routine mammogram taken at 12 months post surgery
Secondary outcome [5] 380809 0
Breast Symmetry assessed using 3D Surface imagery Photography (Vectra)
Timepoint [5] 380809 0
Baseline and end of treatment (3 weeks)
Secondary outcome [6] 380810 0
Subdermal thickness assessed by ultrasound
Timepoint [6] 380810 0
Baseline and end of treatment (3 weeks)
Secondary outcome [7] 380811 0
Dermal thickness assessed by MRI.
Timepoint [7] 380811 0
Baseline and end of treatment (3 weeks)
Secondary outcome [8] 380812 0
Subdermal thickness assessed by MRI.
Timepoint [8] 380812 0
Baseline and end of treatment (3weeks)

Eligibility
Key inclusion criteria
• Women aged 18 years old or older.
• Early breast cancer diagnosis (T0is-T3, N0-3, M0), Stage I-III ipsilateral breast cancer treated with BCS
• RT delivered following BCS
• RT completed 3 months to 3 years ago
• completed any adjuvant therapy (excluding hormone treatments) at least 6 months previously;
• Bothersome breast oedema (score of equal or greater than 3 on BOB visual analogue scale)
• Available for initial breast oedema assessment, treatment (six treatments over 3 weeks)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Aged <18 years old
• Currently receiving lymphoedema treatment for breast lymphoedema
• Breast implants – prior or current
• Previous RT treatment to either breast, contralateral chest wall or thoracic region
• Pregnant
• Metastatic disease
• Mastectomy +/- reconstruction,
• Previous contralateral breast cancer treatment
• Bilateral breast cancer
• Unable to attend for breast oedema assessment and treatment
• have a pacemaker, metal implant, suffer from claustrophobia, are unable to lie on their stomach with arms above their head or any other MRI-incompatible implant;
• Skin concerns limiting suitability to receive treatment

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 will occur after the baseline measures are completed by a person not involved with the project who will prepare sequentially numbered opaque envelopes with the group allocation sealed inside.
.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be computer generated by a person not involved with the project following the baseline measurements
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary aim (PROM change), with two groups of 20 patients in each group (40 patients in total), there is a 80% power of detecting a statistically significant difference between the treatment arm and the non treatment arm with an effect size of 0.74 using a 5% significance level (2 sided t test). We will comparing change at baseline and end of treat and between the intervention and non intervention arms accounting for 10% drop out.
• Null hypothesis:
Change in PROM in non intervention group = Change in the intervention group
• Alternative hypothesis:
Change in PROM in non intervention group does not equal Change in the intervention group
Statistical Analysis Plan
Primary Outcome:
The 2 sided t test (5% significance level) will be used to analyse the primary outcome of PROM change.
Secondary Outcomes:
Spearman rank correlations will be used to look at associations between MRI and the other measurement techniques. Logistic regression analysis will be used for the patient report outcome measures and determing the strength of association in any of the scales.
Changes will be analysed using descriptive analysis including means/standard deviations or median and interquartile range. Data extracted from the different imaging approaches will be compared using paired t-tests and 95% confidence intervals if data are normally distributed otherwise using non-parametric methods.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
29/01/2021
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
22/12/2022
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15770 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 29203 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 302809 0
Charities/Societies/Foundations
Name [1] 302809 0
Westmead Medical Research Foundation
Country [1] 302809 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Cnr Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 305194 0
None
Name [1] 305194 0
Address [1] 305194 0
Country [1] 305194 0
Other collaborator category [1] 281160 0
University
Name [1] 281160 0
University of Sydney
Address [1] 281160 0
The University of Sydney
NSW 2006
Australia
Country [1] 281160 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303393 0
Western Sydney Local Health District
Ethics committee address [1] 303393 0
Ethics committee country [1] 303393 0
Australia
Date submitted for ethics approval [1] 303393 0
06/03/2020
Approval date [1] 303393 0
13/07/2020
Ethics approval number [1] 303393 0
2020/ETH00258

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

Contacts
Principal investigator
Name 93522 0
Dr Kirsty Stuart
Address 93522 0
Westmead Breast Cancer Institute
Block F/189 Cnr Hawkesbury & Darcy Rd,
Westmead NSW 2145
Country 93522 0
Australia
Phone 93522 0
+61417 864 100
Fax 93522 0
Email 93522 0
[email protected]
Contact person for public queries
Name 93523 0
Nicola Fearn
Address 93523 0
University of Sydney
Sydney School of Health Sciences, Faculty of Medicine and Health, PO Box 170 (75 East St)| Lidcombe NSW 1825
Country 93523 0
Australia
Phone 93523 0
+61 435625365
Fax 93523 0
Email 93523 0
[email protected]
Contact person for scientific queries
Name 93524 0
Nicola Fearn
Address 93524 0
University of Sydney
Sydney School of Health Sciences, Faculty of Medicine and Health, PO Box 170 (75 East St)| Lidcombe NSW 1825
Country 93524 0
Australia
Phone 93524 0
+61 435625365
Fax 93524 0
Email 93524 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


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.