NCT06708754Toboroz
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 30.
Rövid összefoglaló (regiszter, angolul)
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. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact. This is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2024. nov. 26.
- Kezdés
- 2025. febr. 13.
- Elsődleges befejezés
- 2028. febr. 13.
- Fő szponzor
- NYU Langone Health
- Betegségek
- Fej-nyaki daganatok
- NCT-szám
- NCT06708754
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 60
- 2025. febr. 13. és az elsődleges befejezés (2028. febr. 13.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
- Patients who received prior PBM therapy for RT toxicities in the last year;
- Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
Egyéb
- Woman who are pregnant or planning to become pregnant or breast-feeding.
- Patients deprived of freedom, under supervision or guardianship.
- Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
- Patients who report being photosensitive.
- 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.
Kiket keres a vizsgálat
- 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. Subjects 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| NYU Langone Health | New York | Egyesült Államok | Toboroz |
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