Breast Cancer LymphedemaNCT05725265
LLLT for BCRL: a Randomized, Placebo-controlled Study
A study testing Large-area low-level laser therapy(Venusure) and Conventional low-level laser therapy in people with Breast Cancer Lymphedema, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Large-area low-level laser therapy(Venusure) and Conventional low-level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Oct 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects, 20 years age or older, suffered from unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
- Stage I or II unilateral secondary upper extremity lymphedema(as defined by the International Society of Lymphology)
- Girth≥ 2 cm circumferential difference compared with the uninvolved upper extremity at any 4 cm segment
- Able to commit to a long-term follow-up schedule
Who cannot join
- Metastatic cancer(stage IV)
- Pregnancy
- Presence of other extremity lymphedema (primary or secondary)
- History of deep vein thrombosis
- Pacemaker
- Artificial joints, implant or tattoo(area≥4 cm2) at the involved upper extremity
Show all 10Show fewer
- Previous treatment with low-level laser therapy (within 3 months)
- Body mass index (BMI) > 35 (morbid obesity)
- High bleeding tendency(hemophilia)
- Receiving long-term steroid treatment (oral or systemic)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ying-Chun Chen, MD, 23123456 ext. 55177, yasandy2000@gmail.com
About this study
Official title: Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study
This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.
Read the detailed description
Breast cancer-related lymphedema (BCRL) is common complication after cancer treatment. The incidence of BCRL around is 16.6% (95% CI 13·6-20·2) after the diagnosis and higher among the group receiving the sentinel biopsy or axillary lymph dissection. The lymphedema arises from the accumulation of protein-rich lymph fluid in the interstitial spaces then results in chronic inflammation with symptoms of fibrosis, pain, limited range of motion or paresthesia. The BRCL is chronic and progressive condition, and the severity also changes over time. The definition and cut points of BCRL using inter-limb volume or arm circumference varied across the studies by different measure method. Currently, the International Society of Lymphology suggests calculating arm volume from circumferences through the truncated cone formula to qualify the severity. On the other hand, previous research found the skin and subcutis were thickened in the ipsilateral arm of patients with BCRL. Thus, the measurement of skin thickness using ultrasound may also practical to detect the progression of lymphedema. Except for physical change of upper limb, the symptoms of BCRL are also concerned. One of the most common morbidity is pain, mostly presenting 1 month after surgery (56.6%). Furthermore, BCRL might decrease shoulder range of motion. Previous study demonstrated that shoulder mobility was usually restricted at 1 month postoperatively and abduction and forward flexion were limited at first. Thus, functional disability may occurred and life of quality may be influenced. To evaluate the ability to perform functional activities, the Disability of Arm, Shoulder, and Hand Questionnaire (DASH) is an useful tool to assess the patients with BCRL.
Currently, although complete decongestive therapy (CDT) has been the standard therapy, there is still various type of noninvasive treatment on BCRL, for example, low-level laser therapy (LLLT). Low-level laser therapy (LLLT), also named photobiomodulation therapy (PBMT), is a conservative therapy through utilizing wave lengths of red or near infrared light between 650 and 1000 nm to stimulate wound healing and reduce inflammation, edema, and pain. Moreover, the Food and Drug Administration (FDA) approved the use of the LLLT for treatment of postmastectomy lymphedema in November 2006. Previous studies have demonstrated the effect of LLLT on BCRL with comparison to physical therapy or placebo. However, there is still limited data about the LLLT with different light area on improvement of severity and symptoms of BCRL. Therefore, this study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Large-area low-level laser therapy(Venusure), Conventional low-level laser therapy
- Keywords
- Breast Cancer Lymphedema, Lymphedema, Breast cancer, Low level laser therapy
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large-area low-level laser therapy(Venusure)Device
The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions
Conventional low-level laser therapyDevice
The wavelength was 808 nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Large-area low-level laser therapy | Experimental | Large-area low-level laser therapy(Venusure) was administered at proximal forearm, upper arm and axillary region of affected side. The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks. Receives: Device: Large-area low-level laser therapy(Venusure) |
| Conventional low-level laser therapy | Placebo comparator | Conventional low-level laser therapy was administrated on antecubital fossa and the axilla of affected side. The wavelength was 808nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks. Receives: Device: Conventional low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumference discrepancy of bilateral upper arm
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Measured: Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
Circumference discrepancy of bilateral upper arm
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Measured: Day 60 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
Circumference discrepancy of bilateral upper arm
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Measured: Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
Secondary outcomes (4)
visual analogue scale (VAS)
Record visual analogue scale (VAS) to rate the severity of pain. The total score ranges from 0 to 10. Higher score indicates greater pain intensity.
Measured: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Range of motion of involved shoulder
involved upper extremity.
Measured: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Skin thickness
Use ultrasound to measure the skin thickness of arm and forearm of involved upper extremity.
Measured: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
QuickDASH
QuickDASH(Quick Disabilities of Arm, Shoulder \& Hand) is a questionnaire for patients presenting with self-reported disabilities of the arm, shoulder and hand. The QuickDASH contains 11-items; the score of each item ranges from 1 to 5 and total score ranges from 0 to 100. Higher score indicates greater level of disability and severity.
Measured: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start24 Oct 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chueh-Hung Wu, PHD, Study chair, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725265
- Sponsor's protocol ID
- 202210064DIPD
- Status last verified
- Oct 2024
- First submitted
- 8 Jan 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
PubMed 23540561Grada AA, Phillips TJ. Lymphedema: Pathophysiology and clinical manifestations. J Am Acad Dermatol. 2017 Dec;77(6):1009-1020. doi: 10.1016/j.jaad.2017.03.022.
PubMed 29132848Eyigor S, Cinar E, Caramat I, Unlu BK. Factors influencing response to lymphedema treatment in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Sep;23(9):2705-10. doi: 10.1007/s00520-015-2633-9. Epub 2015 Feb 8.
PubMed 25663541Mellor RH, Bush NL, Stanton AW, Bamber JC, Levick JR, Mortimer PS. Dual-frequency ultrasound examination of skin and subcutis thickness in breast cancer-related lymphedema. Breast J. 2004 Nov-Dec;10(6):496-503. doi: 10.1111/j.1075-122X.2004.21458.x.
PubMed 15569205Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol. 2002 Oct;9(8):745-53. doi: 10.1007/BF02574496.
PubMed 12374657Verbelen H, Gebruers N, Eeckhout FM, Verlinden K, Tjalma W. Shoulder and arm morbidity in sentinel node-negative breast cancer patients: a systematic review. Breast Cancer Res Treat. 2014 Feb;144(1):21-31. doi: 10.1007/s10549-014-2846-5. Epub 2014 Feb 5.
PubMed 24496928Lee D, Hwang JH, Chu I, Chang HJ, Shim YH, Kim JH. Analysis of factors related to arm weakness in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Aug;23(8):2297-304. doi: 10.1007/s00520-014-2584-6. Epub 2015 Jan 10.
PubMed 25576430Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355.
PubMed 28009597Robijns J, Censabella S, Bulens P, Maes A, Mebis J. The use of low-level light therapy in supportive care for patients with breast cancer: review of the literature. Lasers Med Sci. 2017 Jan;32(1):229-242. doi: 10.1007/s10103-016-2056-y. Epub 2016 Aug 19.
PubMed 27539464Wang Y, Ge Y, Xing W, Liu J, Wu J, Lin H, Lu Y. The effectiveness and safety of low-level laser therapy on breast cancer-related lymphedema: An overview and update of systematic reviews. Lasers Med Sci. 2022 Apr;37(3):1389-1413. doi: 10.1007/s10103-021-03446-3. Epub 2021 Nov 15.
PubMed 34779937Levenhagen K, Davies C, Perdomo M, Ryans K, Gilchrist L. Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association. Phys Ther. 2017 Jul 1;97(7):729-745. doi: 10.1093/ptj/pzx050.
PubMed 28838217
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05725265
- Acronym / sponsor ID
- 202210064DIPD
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Breast Cancer Lymphedema, Lymphedema, Breast cancer, Low level laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.
Detailed description
Breast cancer-related lymphedema (BCRL) is common complication after cancer treatment. The incidence of BCRL around is 16.6% (95% CI 13·6-20·2) after the diagnosis and higher among the group receiving the sentinel biopsy or axillary lymph dissection. The lymphedema arises from the accumulation of protein-rich lymph fluid in the interstitial spaces then results in chronic inflammation with symptoms of fibrosis, pain, limited range of motion or paresthesia. The BRCL is chronic and progressive condition, and the severity also changes over time. The definition and cut points of BCRL using inter-limb volume or arm circumference varied across the studies by different measure method. Currently, the International Society of Lymphology suggests calculating arm volume from circumferences through the truncated cone formula to qualify the severity. On the other hand, previous research found the skin and subcutis were thickened in the ipsilateral arm of patients with BCRL. Thus, the measurement of skin thickness using ultrasound may also practical to detect the progression of lymphedema. Except for physical change of upper limb, the symptoms of BCRL are also concerned. One of the most common morbidity is pain, mostly presenting 1 month after surgery (56.6%). Furthermore, BCRL might decrease shoulder range of motion. Previous study demonstrated that shoulder mobility was usually restricted at 1 month postoperatively and abduction and forward flexion were limited at first. Thus, functional disability may occurred and life of quality may be influenced. To evaluate the ability to perform functional activities, the Disability of Arm, Shoulder, and Hand Questionnaire (DASH) is an useful tool to assess the patients with BCRL.
Currently, although complete decongestive therapy (CDT) has been the standard therapy, there is still various type of noninvasive treatment on BCRL, for example, low-level laser therapy (LLLT). Low-level laser therapy (LLLT), also named photobiomodulation therapy (PBMT), is a conservative therapy through utilizing wave lengths of red or near infrared light between 650 and 1000 nm to stimulate wound healing and reduce inflammation, edema, and pain. Moreover, the Food and Drug Administration (FDA) approved the use of the LLLT for treatment of postmastectomy lymphedema in November 2006. Previous studies have demonstrated the effect of LLLT on BCRL with comparison to physical therapy or placebo. However, there is still limited data about the LLLT with different light area on improvement of severity and symptoms of BCRL. Therefore, this study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large-area low-level laser therapy | Experimental | Device: Large-area low-level laser therapy(Venusure)Large-area low-level laser therapy(Venusure) was administered at proximal forearm, upper arm and axillary region of affected side. The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks. |
| Conventional low-level laser therapy | Placebo comparator | Device: Conventional low-level laser therapyConventional low-level laser therapy was administrated on antecubital fossa and the axilla of affected side. The wavelength was 808nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female subjects, 20 years age or older, suffered from unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
- Stage I or II unilateral secondary upper extremity lymphedema(as defined by the International Society of Lymphology)
- Girth≥ 2 cm circumferential difference compared with the uninvolved upper extremity at any 4 cm segment
- Able to commit to a long-term follow-up schedule
Key exclusion criteria (10 listed)
- Metastatic cancer(stage IV)
- Pregnancy
- Presence of other extremity lymphedema (primary or secondary)
- History of deep vein thrombosis
- Pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Large-area low-level laser therapy(Venusure)The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions | Device | Large-area low-level laser therapy |
| Conventional low-level laser therapyThe wavelength was 808 nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions. | Device | Conventional low-level laser therapy |
Primary outcome
Circumference discrepancy of bilateral upper arm
Time frame: Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Circumference discrepancy of bilateral upper arm
Time frame: Day 60 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Circumference discrepancy of bilateral upper arm
Time frame: Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
4 secondary outcomes
visual analogue scale (VAS)
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Range of motion of involved shoulder
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Skin thickness
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
QuickDASH
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 23540561DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
- Background: PubMed 29132848Grada AA, Phillips TJ. Lymphedema: Pathophysiology and clinical manifestations. J Am Acad Dermatol. 2017 Dec;77(6):1009-1020. doi: 10.1016/j.jaad.2017.03.022.
- Background: PubMed 25663541Eyigor S, Cinar E, Caramat I, Unlu BK. Factors influencing response to lymphedema treatment in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Sep;23(9):2705-10. doi: 10.1007/s00520-015-2633-9. Epub 2015 Feb 8.
- Background: PubMed 15569205Mellor RH, Bush NL, Stanton AW, Bamber JC, Levick JR, Mortimer PS. Dual-frequency ultrasound examination of skin and subcutis thickness in breast cancer-related lymphedema. Breast J. 2004 Nov-Dec;10(6):496-503. doi: 10.1111/j.1075-122X.2004.21458.x.
- Background: PubMed 12374657Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol. 2002 Oct;9(8):745-53. doi: 10.1007/BF02574496.
- Background: PubMed 24496928Verbelen H, Gebruers N, Eeckhout FM, Verlinden K, Tjalma W. Shoulder and arm morbidity in sentinel node-negative breast cancer patients: a systematic review. Breast Cancer Res Treat. 2014 Feb;144(1):21-31. doi: 10.1007/s10549-014-2846-5. Epub 2014 Feb 5.
- Background: PubMed 25576430Lee D, Hwang JH, Chu I, Chang HJ, Shim YH, Kim JH. Analysis of factors related to arm weakness in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Aug;23(8):2297-304. doi: 10.1007/s00520-014-2584-6. Epub 2015 Jan 10.
- Background: PubMed 28009597Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355.
- Background: PubMed 27539464Robijns J, Censabella S, Bulens P, Maes A, Mebis J. The use of low-level light therapy in supportive care for patients with breast cancer: review of the literature. Lasers Med Sci. 2017 Jan;32(1):229-242. doi: 10.1007/s10103-016-2056-y. Epub 2016 Aug 19.
- Background: PubMed 34779937Wang Y, Ge Y, Xing W, Liu J, Wu J, Lin H, Lu Y. The effectiveness and safety of low-level laser therapy on breast cancer-related lymphedema: An overview and update of systematic reviews. Lasers Med Sci. 2022 Apr;37(3):1389-1413. doi: 10.1007/s10103-021-03446-3. Epub 2021 Nov 15.
- Background: PubMed 28838217Levenhagen K, Davies C, Perdomo M, Ryans K, Gilchrist L. Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association. Phys Ther. 2017 Jul 1;97(7):729-745. doi: 10.1093/ptj/pzx050.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chueh-Hung Wu, PHD study chair
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large-area low-level laser therapy(Venusure) and Conventional low-level laser therapy in people with Breast Cancer Lymphedema, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Chun Chen, MD (23123456 ext. 55177, yasandy2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circumference discrepancy of bilateral upper arm (time frame: Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05725265, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.