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Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Study acronym: LymphLight
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary endpoints: 27 to 34
    • Interventions: Photobiomodulation therapy (PBMT) (Device), Sham PBMT (Device) to Manual Lymphatic drainage (Procedure), Photobiomodulation therapy (PBMT) (Device)
    • Secondary endpoints: 26 to 33
    v5
  3. Notable Primary endpoints: 26 to 27v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2028 to Feb 2028
    • Start date changed from estimate of Jan 2021 to Feb 22, 2021
    • Site details revised at 2 of 2 sites
    v3
  5. Minor Start date: Dec 2020 to Jan 2021v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04690439
Lead Sponsor Jessa Hospital
Collaborators: Hasselt University
Conditions
(from sponsor)
Breast Cancer, Breast Cancer Related Lymphedema, Lymphedema of Upper Arm
Related terms Breast Cancer Lymphedema, Breast Neoplasms, Lymphedema
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov