Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000629538
Ethics application status
Approved
Date submitted
27/05/2015
Date registered
17/06/2015
Date last updated
5/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low level laser treatment for women showing signs and symptoms of capsular contracture following implant-based breast reconstruction for breast cancer (LaTCon study)
Scientific title
A double blinded randomized controlled trial of women with breast cancer who have had mastectomy followed by implant based reconstruction to assess signs and symptoms of capsular contracture following treatment with laser therapy.
Secondary ID [1] 286799 0
Nil
Universal Trial Number (UTN)
U1111-1170-5760
Trial acronym
LaTCon
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 295176 0
Capsular Contracture 295293 0
Condition category
Condition code
Cancer 295420 295420 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is laser therapy using Riancorp LTU-904 a class 1 low level laser, the participants will undergo 6 sixteen minute sessions spread over 6 weeks. This will be administered by either the Principal Investigator Dr Farhad Azimi, or the Research Nurse Rebecca Karantonis. The laser has a wavelength of 900nm and an output power of 5.0mW. There are 16x1cm diameter spots spaced 2cm apart in a square formation. The dose equals 1.5 Joules per cm2 per spot.
Intervention code [1] 291957 0
Treatment: Devices
Comparator / control treatment
The control device is a placebo using a deactivated Riancorp LTU-904. Neither the Prinicipal Investigator or the Research Nurse will know which laser has been activated. The devices are identical and sound the same when in use. The participants in the control group will also undergo 6 sixteen minute sessions spread over 6 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 295157 0
This is a composite primary outcome to determine if treatment with low level laser can improve the symptoms and signs of capsular contracture following expander/implant reconstruction, namely: -pain -tightness -limited arm movement -cosmesis (appearance) The following validating tools will be used: Participants will complete the PROCCON questionnaire (Patient Reported Outcomes of Capsular CONtracture). Clinicians will complete the BRASS questionnaire.
Timepoint [1] 295157 0
Baseline, 6 weeks prior to treatment, and at 1 and 6 months post end of treatment.
Secondary outcome [1] 314891 0
To determine if LLL can improve capsular contracture to the extent that it negates the need for revision surgery.
The validating tools for this would be:
BRASS assessment form and a clinical examination by the clinician.
Timepoint [1] 314891 0
12 months post end of treatment.

Eligibility
Key inclusion criteria
Previous recruitment to either the:
“Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic and quality of life outcomes” study (the RT Study) (ACTRN12614000078651).

OR

“A pilot study to assess the feasibility of prospective assessment of a comprehensive set of patient-reported outcomes that impact on Quality of Life of women undergoing Immediate, Delayed and no breast reconstruction following mastectomy and adjuvant radiotherapy for breast cancer (the QoLID Study). (ACTRN 12614000045617).

OR

Non-trial patients, identified through clinic records, who meet the following criteria:
1. Undergone mastectomy for breast cancer
2. Completed their definitive implant-based reconstruction at least six months ago
3. Willing to complete a pre-treatment patient questionnaire to assess their degree of capsular contracture
4. Have clinically detectible capsular contracture based on the score derived from the pre-treatment questionnaire
5. Able to read and write English to a level required for completion of informed consent and questionnaires.
6. Willing to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Any metastatic disease other than stable bone metastases.
3. Unable to read and write English to a level required for consent and completion of written questionnaires.
4. Unwilling to provide 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)
All potential participants will be asked to complete a printed or electronic pre-treatment questionnaire which will identify if they have capsular contracture or not. This screening email/letter will contain a consent form to obtain their permission to collect their clinical information.
Those who do have significant capsular contracture will be sent a second email/letter, asking them if they are interested in participating in a trial of a non-surgical intervention that may improve their condition.
Women who would like to participate in the trial will be asked to contact the research nurse who will arrange an initial appointment with the doctor.
Written consent will be obtained at this appointment prior to any clinical examination or treatment commencing.
The results of this initial examination will be recorded on the BRASS post-operative questionnaire.
Consenting participants will be randomised to two groups: Laser A or Laser B. Block randomisation will be done using excel by a person off site not directly involved with the trial. Women in one group will receive treatment with an activated LLL (Riancorp LTU-904) while those in the other group will receive treatment with a deactivated LLL (Riancorp LTU-904). The hand held laser devices will appear and sound identical and neither the participant nor the investigators will know whether the Laser being used is activated (a double blinded methodology). The supplier will only inform the investigators about which laser was active once the data collection is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using excel will be conducted via a person off site who is not directly involved in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An estimated 40 patients (20 intervention, 20 control) will need to be recruited in order to detect a clinically significant improvement in symptoms (defined as a score difference of 2.3 out of 10), to a 2 sided significance level of 95%.

If a variable is approximately normally distributed, then the range is approximately +/- 2 standard deviations. Given the range of the rating scales’ score is 1 to 10, then an approximation of the standard deviation is range/4 = 2.5. While this calculation is approximate, it is a reasonable estimate given there is nothing available in the literature to suggest a better alternative. With this standard deviation and 20 participants per arm, the study would detect a difference in mean scores of 2.3 (out of 10). In other words, this sample size would detect an effect size of 0.9 (effect size = mean difference /standard deviation) with 80% power and significance level of 0.05. A difference of 2.3 should be clinically significant, as an effect size of 0.5 has been suggested as clinically meaningful for quality of life outcomes.

Comparative statistics will be used to identify significant differences in results with treatment with laser A or laser B. Descriptive statistics will be used to analyse and describe the data obtained from questionnaires and surgeon aesthetic ratings, which will be scored according to standard scoring criteria published in the literature. Cross tabulations of major variables will be conducted to identify any correlations between treatment and improvement of particular signs or symptoms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2015
Actual
4/06/2015
Date of last participant enrolment
Anticipated
3/02/2016
Actual
10/02/2016
Date of last data collection
Anticipated
Actual
9/09/2016
Sample size
Target
40
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3846 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 9731 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 291362 0
Hospital
Name [1] 291362 0
Mater Hospital
Country [1] 291362 0
Australia
Primary sponsor type
Other
Name
Breast & Surgical Oncology at The Poche Centre
Address
40 Rocklands Rd, North Sydney, NSW, 2060
Country
Australia
Secondary sponsor category [1] 290042 0
None
Name [1] 290042 0
Address [1] 290042 0
Country [1] 290042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292923 0
St Vincents Hospital
Ethics committee address [1] 292923 0
390 Victoria St, Darlinghurst, NSW, 2010
Ethics committee country [1] 292923 0
Australia
Date submitted for ethics approval [1] 292923 0
27/03/2015
Approval date [1] 292923 0
07/04/2015
Ethics approval number [1] 292923 0
15/027

Summary
Brief summary
The study is investigating if treatment with a low level laser can help improve the signs and symptoms of capsular contracture: chest pain, chest tightness, limited arm movement and unsatisfactory appearance of the affected breast(s).

Who is it for?
Potential participants who have undergone mastectomy and breast reconstruction (with tissue expander/implant) will be identified from the databases of the RT and QoLID studies as well as from participating surgeons’ patient files.

Study Details
All participants will complete a pre-treatment questionnaire to determine if they have significant capsular contracture, those who do and have consented to participating in the trial will then be randomly assigned to a group (A or B). They will then undergo an initial clinical examination by a Clinician followed by 6x16min low level laser therapy sessions at weekly intervals. One of the groups will receive the laser therapy while the other group will be treated with a deactivated laser. Neither the clinician administering the treatment or the participant will know which group is receiving the active therapy. At the conclusion of the treatment participants will undergo clinical and aesthetic assessments as well as complete the initial questionnaire at the 1 and 6 month post treatment mark.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57570 0
Dr Farhad Azimi
Address 57570 0
Breast & Surgical Oncology at The Poche Centre, 40 Rocklands Rd, North Sydney, NSW, 2060.
Country 57570 0
Australia
Phone 57570 0
+61 2 9911 7312
Fax 57570 0
Email 57570 0
fred.azimi.54@gmail.com
Contact person for public queries
Name 57571 0
Dr Kathy Flitcroft
Address 57571 0
Breast & Surgical Oncology at The Poche Centre, 40 Rocklands Rd, North Sydney, NSW, 2060.
Country 57571 0
Australia
Phone 57571 0
+61 2 9911 7312
Fax 57571 0
Email 57571 0
kathy.flitcroft@melanoma.org.au
Contact person for scientific queries
Name 57572 0
Dr Farhad Azimi
Address 57572 0
Breast & Surgical Oncology at The Poche Centre, 40 Rocklands Rd, North Sydney, NSW, 2060.
Country 57572 0
Australia
Phone 57572 0
+61 2 9911 7312
Fax 57572 0
Email 57572 0
fred.azimi.54@gmail.com

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseLow-Level Laser Treatment Is Ineffective for Capsular Contracture: Results of the LaTCon Randomized Controlled Trial.2018https://dx.doi.org/10.1097/PRS.0000000000004826
N.B. These documents automatically identified may not have been verified by the study sponsor.