Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Uptake (trial consent rate)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
RIANCORP
- The therapist will complete 5 minutes of manual lymphatic drainage (MLD) prior to photo-biomodulation (PBM)
- 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. The Riancorp has an in-built timer that signals the end of 60 seconds.
HANDYCURE PROTOCOL The Handycure device will be used at home by the patients, in addition to the usual care. Education, including written instruction sheets in how patients are to perform MLD, and use of the device will be provided.
The device is to be used once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk)
- Patients will complete 5 min of MLD prior to PBM
- They will then apply the device for 5 minutes at each point.
Telehealth physio (wks 1, 6 and 9) post baseline will check usage, adherence and monitor safety.
干预措施: Riancorp LTU-904 Laser and Handycure® (Medical Quant) (Device)
结局指标
主要结局
Uptake (trial consent rate)
时间窗: Throughout the trial for 12-months of recruitment
Consent rate and reasons for declining trial participation
次要结局
- Program adherence(Throughout the trial for 12-months of recruitment and completion of 3-month follow-up)
- Adverse events(Throughout the trial for 12-months of recruitment)
- Retention(3-months post-baseline)
- Shoulder range of motion(Baseline and 3-months post-baseline)
- Acceptability(Three months post baseline)
- Lymphoedema(Baseline and 3-months post-baseline)
- Cervical spine range of motion(Baseline and 3-months post-baseline)
- Percentage water content (PWC) of skin(Baseline and 3-months post-baseline)
- Trismus(Baseline and 3-months post-baseline)
- Neck circumference(Baseline and 3-months post-baseline)
- Health-related quality of life(Baseline and 3-months post-baseline)