None listed
Conditions
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.
Interventions
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.
Sponsors
Breast & Surgical Oncology at The Poche Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed