Low level laser therapy in the management of breast cancer-related lymphedema: protocol for a randomized controlled feasibility trial

Abstract

Background: Breast cancer-related lymphedema (BCRL) is a prevalent long-term condition secondary to cancer treatment. BCRL impacts physical function, psychological health, and quality of life for patients who have survived breast cancer.

Objectives: This study will assess the feasibility of a fully-powered randomized controlled trial investigating the effectiveness of low level laser therapy (LLLT), also known as photobiomodulation (PBM) therapy, as an adjunct treatment for managing BCRL.

Methods: This study will be a pragmatic two-armed randomized controlled feasibility trial. Twenty female participants being treated for BCRL at the Dunedin Hospital, New Zealand, will be recruited over a 6-month window. Subject to informed consent, participants will be offered LLLT (PBM) in addition to their regular treatment for BCRL. Twelve treatments with laser therapy will continue for 6 weeks (twice weekly). Feasibility outcomes (recruitment rate, randomization rate, participant’s adherence to the LLLT (PBM) treatment protocol, and participant retention rates) will be collected during the recruitment and intervention period. Participant satisfaction will be collected on completion of treatment intervention. Safety outcomes of LLLT (PBM) will be collected at each treatment visit. Clinical outcome measures (limb circumference, participant’s perceived symptoms, psychological impacts, and activity disability) will be assessed at baseline, 6 and 12 weeks post-randomization.

Conclusions: Results of this feasibility trial will inform the design and implementation of a future definitive randomized controlled trial, which will investigate the effectiveness of LLLT (PBM) for women with BCRL.

Keywords:

• Photobiomodulation therapy
• women
• limb
• parameters
• New Zealand

Acknowledgements

Members of the Laser Lymphedema Trial Team: G David Baxter, Lizhou Liu, Simone Petrich, Cathy Chapple, Juanita J Anders, Steve Tumilty, Andrew Gray, Jane Rankin, Deb Handcock, Olivia Shirley, Lesley Inglis, Kate Jerram, Evelyn Tulloch, Marina Moss, Karen Taylor, Fay Devlin, Zoe Cook, and Sarah Byrnes.

Disclosure statement

The authors declare that they have no conflicts of interests.

Additional information

Funding

This project is funded by the New Zealand Breast Cancer Foundation, the support of which is gratefully acknowledged. This funding source has no role in this study other than providing funding support. LiteCure (250 Corporate Blvd Ste B, Newark, DE 19702, USA) has provided the loan of the laser therapy unit for this trial; this company has no role in the study other than providing loan of the equipment.

Notes on contributors

G. David Baxter

GDB is the Principal Investigator, responsible for the design, implementing and overall supervision of the trial, and drafting and revising this paper. LL is the Research Trial Manager, participates in the design and implementing of the trial, responsible for trial coordination and data collection, and drafting and revising this paper. SP is a Co-investigator and a Breast Surgeon, participates in the design and implementing of the trial, and revising of this paper. CC, JJA, and ST are Co-investigators, participate in the design and implementing of the trial, and assist in revising this paper. JR is the Lead for the Lymphedema Network Northern Ireland, and is an international adviser to the laser treatment protocol of the trial. AG is a biostatistician, responsible for sample size estimates and statistics methodology. DH and OS are lymphedema physiotherapists, and contribute to participant recruitment. LI, KJ, and ET are the laser physiotherapists, delivering the laser treatment. MM is the Clinical Research Administrator, who completes participant screening, and developing and implementing of the randomization procedures. KT is the Clinic Director, and contributes to the overall management of the clinical activity within the trial. FD, ZC, and SB are the Clinic Administrators, who schedule laser treatment bookings for participants. All named authors read and approved the final manuscript.

Lizhou Liu

GDB is the Principal Investigator, responsible for the design, implementing and overall supervision of the trial, and drafting and revising this paper. LL is the Research Trial Manager, participates in the design and implementing of the trial, responsible for trial coordination and data collection, and drafting and revising this paper. SP is a Co-investigator and a Breast Surgeon, participates in the design and implementing of the trial, and revising of this paper. CC, JJA, and ST are Co-investigators, participate in the design and implementing of the trial, and assist in revising this paper. JR is the Lead for the Lymphedema Network Northern Ireland, and is an international adviser to the laser treatment protocol of the trial. AG is a biostatistician, responsible for sample size estimates and statistics methodology. DH and OS are lymphedema physiotherapists, and contribute to participant recruitment. LI, KJ, and ET are the laser physiotherapists, delivering the laser treatment. MM is the Clinical Research Administrator, who completes participant screening, and developing and implementing of the randomization procedures. KT is the Clinic Director, and contributes to the overall management of the clinical activity within the trial. FD, ZC, and SB are the Clinic Administrators, who schedule laser treatment bookings for participants. All named authors read and approved the final manuscript.

Simone Petrich

GDB is the Principal Investigator, responsible for the design, implementing and overall supervision of the trial, and drafting and revising this paper. LL is the Research Trial Manager, participates in the design and implementing of the trial, responsible for trial coordination and data collection, and drafting and revising this paper. SP is a Co-investigator and a Breast Surgeon, participates in the design and implementing of the trial, and revising of this paper. CC, JJA, and ST are Co-investigators, participate in the design and implementing of the trial, and assist in revising this paper. JR is the Lead for the Lymphedema Network Northern Ireland, and is an international adviser to the laser treatment protocol of the trial. AG is a biostatistician, responsible for sample size estimates and statistics methodology. DH and OS are lymphedema physiotherapists, and contribute to participant recruitment. LI, KJ, and ET are the laser physiotherapists, delivering the laser treatment. MM is the Clinical Research Administrator, who completes participant screening, and developing and implementing of the randomization procedures. KT is the Clinic Director, and contributes to the overall management of the clinical activity within the trial. FD, ZC, and SB are the Clinic Administrators, who schedule laser treatment bookings for participants. All named authors read and approved the final manuscript.

Cathy Chapple

GDB is the Principal Investigator, responsible for the design, implementing and overall supervision of the trial, and drafting and revising this paper. LL is the Research Trial Manager, participates in the design and implementing of the trial, responsible for trial coordination and data collection, and drafting and revising this paper. SP is a Co-investigator and a Breast Surgeon, participates in the design and implementing of the trial, and revising of this paper. CC, JJA, and ST are Co-investigators, participate in the design and implementing of the trial, and assist in revising this paper. JR is the Lead for the Lymphedema Network Northern Ireland, and is an international adviser to the laser treatment protocol of the trial. AG is a biostatistician, responsible for sample size estimates and statistics methodology. DH and OS are lymphedema physiotherapists, and contribute to participant recruitment. LI, KJ, and ET are the laser physiotherapists, delivering the laser treatment. MM is the Clinical Research Administrator, who completes participant screening, and developing and implementing of the randomization procedures. KT is the Clinic Director, and contributes to the overall management of the clinical activity within the trial. FD, ZC, and SB are the Clinic Administrators, who schedule laser treatment bookings for participants. All named authors read and approved the final manuscript.

Juanita J. Anders

GDB is the Principal Investigator, responsible for the design, implementing and overall supervision of the trial, and drafting and revising this paper. LL is the Research Trial Manager, participates in the design and implementing of the trial, responsible for trial coordination and data collection, and drafting and revising this paper. SP is a Co-investigator and a Breast Surgeon, participates in the design and implementing of the trial, and revising of this paper. CC, JJA, and ST are Co-investigators, participate in the design and implementing of the trial, and assist in revising this paper. JR is the Lead for the Lymphedema Network Northern Ireland, and is an international adviser to the laser treatment protocol of the trial. AG is a biostatistician, responsible for sample size estimates and statistics methodology. DH and OS are lymphedema physiotherapists, and contribute to participant recruitment. LI, KJ, and ET are the laser physiotherapists, delivering the laser treatment. MM is the Clinical Research Administrator, who completes participant screening, and developing and implementing of the randomization procedures. KT is the Clinic Director, and contributes to the overall management of the clinical activity within the trial. FD, ZC, and SB are the Clinic Administrators, who schedule laser treatment bookings for participants. All named authors read and approved the final manuscript.

Steve Tumilty

GDB is the Principal Investigator, responsible for the design, implementing and overall supervision of the trial, and drafting and revising this paper. LL is the Research Trial Manager, participates in the design and implementing of the trial, responsible for trial coordination and data collection, and drafting and revising this paper. SP is a Co-investigator and a Breast Surgeon, participates in the design and implementing of the trial, and revising of this paper. CC, JJA, and ST are Co-investigators, participate in the design and implementing of the trial, and assist in revising this paper. JR is the Lead for the Lymphedema Network Northern Ireland, and is an international adviser to the laser treatment protocol of the trial. AG is a biostatistician, responsible for sample size estimates and statistics methodology. DH and OS are lymphedema physiotherapists, and contribute to participant recruitment. LI, KJ, and ET are the laser physiotherapists, delivering the laser treatment. MM is the Clinical Research Administrator, who completes participant screening, and developing and implementing of the randomization procedures. KT is the Clinic Director, and contributes to the overall management of the clinical activity within the trial. FD, ZC, and SB are the Clinic Administrators, who schedule laser treatment bookings for participants. All named authors read and approved the final manuscript.