UPCC 01325 Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors with Chronic Lymphedema
Study on Photobiomodulation Therapy for Chronic Lymphedema in Head and Neck Cancer Survivors
Brief description of study
The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Head and Neck Cancer, Lymphedema of the Head and Neck
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
>18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.
Exclusion Criteria:
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:
Women of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases
This study investigates the effects of photobiomodulation therapy (PBMT) on chronic lymphedema in survivors of head and neck cancer. PBMT is a type of light therapy that has been approved by the U.S. Food and Drug Administration for treating arm lymphedema related to breast cancer. This study aims to confirm the positive effects of PBMT on lymphedema that persists after head and neck cancer treatment.
Participants in the study will receive either the investigational PBMT or a placebo. The placebo is an inactive substance that looks like the investigational therapy but does not contain any active treatment. The study will assess the effectiveness of PBMT in reducing lymphedema symptoms by comparing it to the placebo treatment. Participants will undergo regular assessments to monitor their condition throughout the study.
- Who can participate: Adults over 18 with chronic lymphedema post head and neck cancer treatment can participate. They must have completed treatment 12 to 60 months ago, have moderate lymphedema at two or more sites, and understand English.
- Study details: Participants will be randomly assigned to receive either photobiomodulation therapy or a placebo, completing questionnaires and attending regular assessments.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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