A study on use of photobiomodulation for mitigating radiation induced neck fibrosis among patients with head and neck cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Fibrosis severity
研究概览
简要总结
Lay summary: Radiation therapy can cause long-term neck stiffness and scarring, known as neck fibrosis, which affects movement and quality of life. A treatment called photobiomodulation therapy (PBMT) uses low-level laser light to reduce side effects of radiation therapy, but most studies only track short-term results (4–6 weeks). This study aims to test if PBMT can help prevent or reduce neck fibrosis over a longer period (12 months).
The study will include patients receiving radiation therapy for head and neck cancer. Participants will be randomly divided into two groups: one receiving standard care (neck, mouth exercises and education booklet) and the other receiving standard care plus PBMT. PBMT will be applied to neck muscles during radiation therapy, and participants will be assessed before treatment and at 3, 6, 9, and 12 months after radiation therapy.
Researchers will measure neck movement, scarring severity, and quality of life to compare the two groups. This study could provide valuable evidence about the long-term benefits of PBMT for managing neck fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Patients diagnosed with head and cancer • Patients planned for radiotherapy (radical/ concurrent/ adjuvant) • Patients consenting for participation in the study.
排除标准
- •â€¢ Patients with recurrent disease • Patients with surgical resection of sternocleidomastoid muscle • Patients with active disease in the area exposed to PBMT delivery • Patients planned for palliative radiotherapy • Patients with tattoos in the region of Photobiomodulation therapy.
结局指标
主要结局
1. Fibrosis severity
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
• Shear wave elastography of the bilateral sternocleidomastoid muscle
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
• LENT SOMA Scale
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
2. Neck range of motion assessment
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
• Goniometry (Angles)
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
• Tape measurements (Distance)
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
3. Quality of life
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
• Functional Assessment of Cancer Therapy- Head and Neck Questionnaire
时间窗: 1. At baseline | 2. Follow up: three, six, nine and 12 months post completion of radiation therapy
次要结局
- Radiation dermatitis (CTCAE)(At the last day of radiation therapy)
研究者
Rachita Gururaj
M. S. Ramaiah College of Physiotherapy