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New treatment option for Radiation Lymphedema
Official title Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
ClinicalTrials.gov ID: NCT06708754
What this study is testing
- What it's testing
- Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients treated with radiation for head and neck cancer who are ≥ 3 months \< 36 months post-RT (last RT).
- Patients who received at least 50Gy of bilateral neck RT. people who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible.
- No evidence of disease as documented by imaging 3 months after completion of RT.
- Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.
- Patient who has body mass index (BMI) \>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas...
You likely can't join if
- Woman who are pregnant or planning to become pregnant or breast-feeding.
- Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
- Patients deprived of freedom, under supervision or guardianship.
- Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
- Patients who received prior PBM therapy for RT toxicities in the last year;
- Patients who report being photosensitive.
See the full eligibility criteria
- Patients treated with radiation for head and neck cancer who are ≥ 3 months \< 36 months post-RT (last RT).
- Patients who received at least 50Gy of bilateral neck RT. people who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible.
- No evidence of disease as documented by imaging 3 months after completion of RT.
- Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.
- Patient who has body mass index (BMI) \>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.
- Willing to comply with all study procedures and be available for the duration of the study.
- Woman who are pregnant or planning to become pregnant or breast-feeding.
- Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
- Patients deprived of freedom, under supervision or guardianship.
- Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
- Patients who received prior PBM therapy for RT toxicities in the last year;
- Patients who report being photosensitive.
- Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
- Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.