NCT04690439

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
22mo left

Started Feb 2021

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2021Feb 2028

First Submitted

Initial submission to the registry

December 3, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

6.9 years

First QC Date

December 3, 2020

Last Update Submit

February 27, 2023

Conditions

Breast CancerBreast Cancer Related LymphedemaLymphedema of Upper Arm

Keywords

LymphedemaBreast cancerPhotobiomodulation

Outcome Measures

Primary Outcomes (34)

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    Baseline

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    week 5

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    week 9

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    Week 14

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    Week 18

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    3 month follow-up

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    6 month follow-up

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    9 month follow-up

  • Arm circumference and volume

    The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter

    12 month follow-up

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    Baseline

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    week 5

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    week 9

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    week 14

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    week 18

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    3 month follow-up

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    6 month follow-up

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    9 month follow-up

  • Arm mobility measurement

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

    12 month follow-up

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.

    Baseline

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    week 5

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    week 9

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    week 14

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    week 18

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    3 month follow-up

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    6 month follow-up

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    9 month follow-up

  • Activity and participation

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).

    12 month follow-up

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    Baseline

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    Week 9

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    Week 18

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    3 month follow-up

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    6 month follow-up

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    9 month follow-up

  • ISL classification

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

    12 month follow-up

Secondary Outcomes (33)

  • Pain assessment

    Baseline

  • Pain assessment

    week 5

  • Pain assessment

    week 9

  • Pain assessment

    week 14

  • Pain assessment

    week 18

  • +28 more secondary outcomes

Other Outcomes (25)

  • General patient-, disease-, and treatment-related information

    Baseline

  • General patient-, disease-, and treatment-related information

    3 month follow-up

  • General patient-, disease-, and treatment-related information

    6 month follow-up

  • +22 more other outcomes

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: Photobiomodulation therapy (PBMT)Procedure: Manual Lymphatic drainage

Group B

ACTIVE COMPARATOR

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).

Device: Photobiomodulation therapy (PBMT)Procedure: Manual Lymphatic drainage

Interventions

Photobiomodulation therapy (PBMT)DEVICE

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

Also known as: LLLT
Group AGroup B
Manual Lymphatic drainagePROCEDURE

Patients will receive twice weekly MLT executed by trained physiotherapist

Also known as: MLT
Group AGroup B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasselt University

Hasselt, Limburg, 3500, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsBreast Cancer LymphedemaLymphedema

Interventions

Low-Level Light TherapyManual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Jeroen Mebis, MD, PhD

    Jessa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolien Robijns, PhD

CONTACT

011337229jolien.robijns@jessazh.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single : outcome assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized, controlled cross-over trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 30, 2020

Study Start

February 22, 2021

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)