None listed
Conditions
Brief summary
This study will assess the feasibility of a fully-powered randomized controlled trial of Low Level Laser Therapy photobiomodulation (LLLT) as an adjunct treatment for management of breast cancer-related lymphedema. We will recruit 20 participants attending for treatment of breast cancer-related lymphedema at the Dunedin Hospital. Patient participants will be recruited over a 6 month window, and subject to informed consent, will be offered LLLT in addition to regular treatment. Twelve treatment with laser will continue for up to 6 weeks (twice weekly), based upon current evidence. We will assess outcome measures at baseline, 6 weeks post randomization, and at 12 weeks post randomization. Primary outcome measures include the feasibility of the recruitment approaches, the acceptability of and adherence to the LLLT for patients with breast cancer-related lymphedema, and the follow-up rates. Secondary outcome measures include limb circumference, participant’s perceptual symptoms, psychological impacts, and activity disability.
Interventions
For those participants randomized to receive Low Level Laser Therapy (LLLT), in addition to usual care as described below, participants will receive 12 sessions of LLLT over a six-week period (twice per week) at the School of Physiotherapy Clinic, University of Otago. Treatment will be performed by a trained registered physiotherapist (Lesley Inglis (LI)) holding a current practising certificate. LI has forty years clinical experience in Physiotherapy (expertise in rehabilitation, neurobiology,
For those participants randomized to receive Low Level Laser Therapy (LLLT), in addition to usual care as described below, participants will receive 12 sessions of LLLT over a six-week period (twice per week) at the School of Physiotherapy Clinic, University of Otago. Treatment will be performed by a trained registered physiotherapist (Lesley Inglis (LI)) holding a current practising certificate. LI has forty years clinical experience in Physiotherapy (expertise in rehabilitation, neurobiology, and management of musculoskeletal disorders), and two years clinical experience in using LLLT to treat patients with musculoskeletal disorders. The parameters for laser therapy treatment are standardised as follows: wavelength 980/810nm (80:20 ratio); output power 500mW; treatment head of 5cm2; irradiance of 100mW/cm2; treatment time per area 1 minute; dosage per area treated 30J (6J/cm2); 10 points of treatment from axilla to wrist; total laser therapy treatment time of 10 minutes; total dosage delivered 300J. A total of 12 treatments will be performed, twice weekly, across a six week period. The latter may be extended to ensure all 12 treatments are provided. LI will be present throughout the treatment, and monitor the participant’s response to LLLT. All the costs relevant to the treatment (e.g. therapist consultation, treatment materials and administration) will be covered by the funding support.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants are eligible if they (1) are women over 18 years old; (2) are referred/attending for breast cancer-related lymphedema treatment at the Department of Physiotherapy in Dunedin Hospital; (3) are able to communicate in English/Mandarin.
Exclusion criteria
Exclusion criteria include: (1) presence of active or suspected metastases; (2) previous attendance for intravenous chemotherapy or radiation therapy in the last 3 months; (3) history of severe trauma/surgery to the arms; (4) occurrence of any acute infection in the arms (e.g. cellulitis) in the last 3 months; (5) photosensitivity; (6) use of laser therapy for lymphedema in the last 3 months; (7) use of medications that affect body fluid (e.g. diuretics) in the last 3 months; (8) postpartum, pregnancy or intended pregnancy; (9) severe psychological disorder or dementia.
Outcome results
None listed