Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial

Обзор

This feasibility trial will test the use of photo-biomodulation (PBM) therapy, predominantly self-delivered in the patient's home for 12-weeks, following completion of radiotherapy treatment for head and neck cancer. The primary objective is to establish feasibility of recruitment (uptake). Secondary objectives are to assess safety, additional elements of feasibility (adherence to the intervention, return of the device and attrition at the 3-month follow-up appointment) and acceptability of the trial to patients. Secondary measures will be performed to assess trends in effects of the intervention (pre-post intervention, within-group measures) for managing lymphoedema and radiation fibrosis.

Вмешательства

• Устройство Riancorp LTU-904 Laser and Handycure® (Medical Quant)
  Riancorp: At the first intervention session the therapist will apply the device for 60 secs each at 14 - 25 points on the face and neck. Most patients will need application of the device at 15 to 20 points The Riancorp runs for 60 seconds, providing 1.5 j/cm2 in 60 seconds. Handycure: used by patients at home once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk) 1. Patients will apply the device for 5 minutes at each point as instructed by the physiotherapist.

Первичные конечные точки

• Uptake (trial consent rate) [Срок оценки: Throughout the trial for 12-months of recruitment]

Вторичные конечные точки (12)

• Adverse events [Срок оценки: Throughout the trial for 12-months of recruitment]
• Acceptability [Срок оценки: Three months post baseline]
• Program adherence [Срок оценки: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up]
• Program adherence [Срок оценки: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up]
• Retention [Срок оценки: 3-months post-baseline]
• Neck circumference [Срок оценки: Baseline and 3-months post-baseline]
• Lymphoedema [Срок оценки: Baseline and 3-months post-baseline]
• Percentage water content (PWC) of skin [Срок оценки: Baseline and 3-months post-baseline]
• Cervical spine range of motion [Срок оценки: Baseline and 3-months post-baseline]
• Shoulder range of motion [Срок оценки: Baseline and 3-months post-baseline]
• Trismus [Срок оценки: Baseline and 3-months post-baseline]
• Health-related quality of life [Срок оценки: Baseline and 3-months post-baseline]

Критерии участия

Критерии включения

• Patient has provided written informed consent using the HOME-PBM patient information and consent form
• Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and/or radiation fibrosis
• Previously received curative-intent treatment (surgery and/or \[chemo\]radiotherapy) for mucosal head and neck cancer
• Patient is able to attend appointments in person
• Adults aged 18 years or older at Screening
• Patient able to speak and read English

Критерии исключения

• Patient has cognitive impairment that in the opinion of the Investigator would interfere with their ability to participate in the trial (e.g., complete outcome measures, perform the intervention)
• Residual or recurrent disease within the head and neck
• Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.)
• Patient has tuberculosis or another form of virulent bacteria
• Patient has a contraindication to receiving PBM treatment
• Patient has no internet enabled device for telehealth video follow-up appointment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Австралия · 1 центр

• Peter MacCallum Cancer Centre — Melbourne

Идентификаторы

NCT: NCT07139782 · 115976

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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