ow level laser treatment for women showing signs and symptoms of capsular contracture following implant-based breast reconstruction for breast cancer (LaTCon study)

Not Applicable

Completed

• Conditions: Breast Cancer; Capsular Contracture; Cancer - Breast

• Registration Number: ACTRN12615000629538
• Lead Sponsor: Breast & Surgical Oncology at The Poche Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Baseline, 6 weeks prior to treatment, and at 1 and 6 months post end of treatment.]

Secondary Outcome Measures

Name	Time	Method
To determine if LLL can improve capsular contracture to the extent that it negates the need for revision surgery.<br>The validating tools for this would be:<br>BRASS assessment form and a clinical examination by the clinician.[12 months post end of treatment.]