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Trial registered on ANZCTR


Registration number
ACTRN12616001126404
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
18/08/2016
Date last updated
23/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Laser Therapy for Lymphedema: Feasibility Trial
Scientific title
Low Level Laser Therapy (Photobiomodulation) in the Management of Breast Cancer-Related Lymphedema: A Randomized Controlled Feasibility Trial
Secondary ID [1] 288547 0
None
Universal Trial Number (UTN)
U1111-1179-7060
Trial acronym
LaserLymph
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer-Related Lymphedema 297653 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297839 297839 0 0
Other physical medicine / rehabilitation
Cancer 297859 297859 0 0
Breast
Cardiovascular 299836 299836 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293927 0
Treatment: Devices
Comparator / control treatment
All participants will be advised to continue their usual care management for breast cancer-related lymphedema during the course of the study. This may include any pragmatic management as directed by lymphedema physiotherapists (e.g. massage and compression garments.) at the Department of Physiotherapy in Dunedin Hospital. Data on usual care treatments received by participants throughout the study will be collected at baseline (Week 0), and at 6 (Week 6) and 12 weeks post randomization (Week 12).
Control group
Active

Outcomes
Primary outcome [1] 297366 0
Feasibility of the recruitment process
i. Number of participants showing interest in joining the trial
ii. Number of participants eligible after completing telephone screening
iii. Number of participants willing to be randomized into the trial from amongst those eligible
iv. Reasons for non-participation and ineligibility
Timepoint [1] 297366 0
Before intervention
Primary outcome [2] 299274 0
Acceptability of the LLLT treatment to participants who are randomized into the usual care plus LLLT group
i. Number of treatment sessions attended (measured by review of participant's treatment log)
ii. Frequency of treatment sessions attended per week (measured by review of participant's treatment log)
iii. Reasons for non-attendance or early withdraw from treatment (measured by review of participant's treatment log)
iv. Adherence to treatment protocol (measured by review of participant's treatment log)
v. Participants feedback on the LLLT treatment: for those participants receive LLLT in addition to usual care for lymphedema, a questionnaire of seven separate questions about participant’s impressions and comments on LLLT treatment will be obtained.
Timepoint [2] 299274 0
During intervention and at discharge
Primary outcome [3] 299275 0
Follow-up rates (measured by review of research assistant's study follow-up log)
Timepoint [3] 299275 0
6 weeks post randomization, and 12 weeks post randomization
Secondary outcome [1] 320829 0
Limb circumference: limb circumference will be measured using a tape measure at five anatomical based points on both arms, including 10cm and 20cm proximal to and 10cm distal to the antecubital fossa, ulnar styloid, and web space. Differences between both arms at each anatomical point will be recorded as delta circumference (delta C): delta C0 at baseline, delta C6 at 6 weeks post randomization, and delta C12 at 12 weeks post randomization.
Timepoint [1] 320829 0
baseline, 6 weeks post randomization, and 12 weeks post randomization
Secondary outcome [2] 326704 0
Perceptual symptoms: participant’s perceptual pain and heaviness in the affected limb over the past week will be self-assessed by two 10-cm Visual Analogue Scale (VAS) scales, where 0 represent no pain/heaviness and 10 are the worst imaginable pain/heaviness ever.
Timepoint [2] 326704 0
baseline, 6 weeks post randomization, and 12 weeks post randomization
Secondary outcome [3] 326705 0
Psychological impacts: participants will be asked to rate the impact of lymphedema on their psychological wellbeing over the past week (e.g. self-consciousness, perception of symptoms, anxiety, and emotions). Response for each item will range from 0 – 10, where 0 indicates ‘not at all affect’ and 10 ‘extremely affect’. Scores for each item will be summed for the total score of psychological impacts.
Timepoint [3] 326705 0
baseline, 6 weeks post randomization, and 12 weeks post randomization
Secondary outcome [4] 326706 0
Activity disability: difficulty for doing specific daily activities due to lymphedema over the past week (i.e. put on bra, tie shoes, wash hair, and hang out washing) will be scored from 0 (no difficulty) to 10 (most difficulty ever).
Timepoint [4] 326706 0
baseline, 6 weeks post randomization, and 12 weeks post randomization

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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.

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 be through contacting the holder of the allocation schedule (clinical research administrator).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data analyses will be conducted at the end of study when all data collection, entry and validation is completed. The analysis will be descriptive in nature and provide estimates of key trial elements to determine whether to proceed a larger definitive randomized controlled trial (RCT). Demographic data and primary outcomes will be classified as continuous or categorical, and appropriate descriptive statistics and percentages will be calculated.

Secondary outcomes will be analysed using SPSS (version 22.0) on a modified intention-to-treat basis excluding participants who have no post-randomization data. Since this is a feasibility study, tests for significance will not be performed. Descriptive statistics will be applied, and focused on confidence interval (CI) estimation. Data will be reported as mean +/- standard deviation, together with 95%CIs. Differences from baseline to the interim (6 weeks post randomization), and the primary endpoint (12 weeks post randomization) will be calculated by subtracting the mean at baseline from that at the relevant time-points, and descriptively compared between groups for the primary endpoint.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7594 0
New Zealand
State/province [1] 7594 0
Otago

Funding & Sponsors
Funding source category [1] 292894 0
Charities/Societies/Foundations
Name [1] 292894 0
The New Zealand Breast Cancer Foundation
Address [1] 292894 0
11 York Street,
Parnell,
Auckland.
PO Box 99 650
Newmarket, Auckland 1149
Country [1] 292894 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith St, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 291638 0
Hospital
Name [1] 291638 0
Dunedin Hospital
Address [1] 291638 0
201 Great King Street, Dunedin 9016
Country [1] 291638 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294394 0
Health & Disability Ethics Committee
Ethics committee address [1] 294394 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294394 0
New Zealand
Date submitted for ethics approval [1] 294394 0
11/07/2016
Approval date [1] 294394 0
28/07/2016
Ethics approval number [1] 294394 0
16/NTA/101

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63566 0
Prof David Baxter
Address 63566 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street, PO Box 56
Dunedin 9054
Country 63566 0
New Zealand
Phone 63566 0
+6434797411
Fax 63566 0
+6434797184
Email 63566 0
david.baxter@otago.ac.nz
Contact person for public queries
Name 63567 0
Prof David Baxter
Address 63567 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street, PO Box 56
Dunedin 9054
Country 63567 0
New Zealand
Phone 63567 0
+6434797411
Fax 63567 0
+6434797184
Email 63567 0
david.baxter@otago.ac.nz
Contact person for scientific queries
Name 63568 0
Prof David Baxter
Address 63568 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
325 Great King Street, PO Box 56
Dunedin 9054
Country 63568 0
New Zealand
Phone 63568 0
+6434797411
Fax 63568 0
+6434797184
Email 63568 0
david.baxter@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary