Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

NCT ID: NCT04690439

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2028-02-29

Brief Summary

Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

Detailed Description

This aim of this study is to determine the efficacy of PBMT in combination with the institutional therapy on the management of BCRL. Therefore, we hypothesize that PBMT in combination with manual lymphatic drainage is able to reduce the limb circumference and the associated pain and improve the QoL of patients with BCRL during treatment and up to 12 months post-treatment.

Primary Objective 1: Arm circumference

The study seeks primarily to determine the effectiveness PBMT and manual lymphatic drainage in reducing the arm circumference in patients with established BCRL during PBM treatment and up to 12 months post-PBMT.

Primary Objective 2: Activity and participation

Another primary aim of this study is to evaluate the effectiveness of PBMT and manual lymphatic drainage in the enhancement of the patients' activity and participation status.

Secondary Objective 1: Pain

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can reduce the BCRL-related pain during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' QoL during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 3: Depression

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' mental status during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 4: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT and manual lymphatic drainage as a treatment for BCRL during the treatment sessions and up to 12 months post-therapy.

Secondary Objective 5: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Conditions

Breast Cancer; Breast Cancer Related Lymphedema; Lymphedema of Upper Arm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions/week), followed by 9 weeks only manual lymphatic drainage.

Group Type: EXPERIMENTAL

Photobiomodulation therapy (PBMT)

Intervention Type: DEVICE

The MLS M6 laser from ASA will be used to apply the laser therapy.

Manual Lymphatic drainage

Intervention Type: PROCEDURE

Patients will receive twice weekly MLT executed by trained physiotherapist

Group B

Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x/week).

Group Type: ACTIVE_COMPARATOR

Photobiomodulation therapy (PBMT)

Intervention Type: DEVICE

The MLS M6 laser from ASA will be used to apply the laser therapy.

Manual Lymphatic drainage

Intervention Type: PROCEDURE

Patients will receive twice weekly MLT executed by trained physiotherapist

Interventions

Photobiomodulation therapy (PBMT)

The MLS M6 laser from ASA will be used to apply the laser therapy.

Intervention Type: DEVICE

Manual Lymphatic drainage

Patients will receive twice weekly MLT executed by trained physiotherapist

Intervention Type: PROCEDURE

Other Intervention Names

LLLT; MLT

Eligibility Criteria

Inclusion Criteria

• Diagnosed with breast cancer
• Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection
• Underwent radiotherapy with or without chemotherapy
• Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)
• Age ≥ 18 years
• Able to comply to the study protocol
• Able to sign written informed consent

Exclusion Criteria

• Metastatic disease
• Pregnancy
• History of surgery or trauma to the arm
• History of arm infection in the past 3 months
• Use of medications that affect body fluid (e.g., diuretics) in the last 3 months
• Severe psychological disorder or dementia
• Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen Mebis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Hasselt University

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jolien Robijns, PhD

Role: CONTACT

jolien.robijns@jessazh.be

011337229

Facility Contacts

Jolien Robijns, PhD

Role: primary

jolien.robijns@uhasselt.be

Jolien Robijns, PhD

Role: primary

Other Identifiers

B2342020000029

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-154

Identifier Type: -

Identifier Source: org_study_id