A Pilot Study to Describe the Effect of Photobiomodulation in Reducing the Severity and Incidence of Oral Mucositis in Oral Cancer Patients Undergoing Radiation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cumulative incidence and severity of acute oral mucositis
研究概览
简要总结
The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +/- chemotherapy.
Participants will receive PBM treatment five times a week throughout the course of their radiotherapy.
The main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.
详细描述
BACKGROUND: Strong evidence exists within the literature regarding the effectiveness and safety of PBM in preventing oral mucositis in head and neck cancer patients. PBM is recommended in the Multinational Association of Supportive Care in Cancer and National Institute of Health and Care Excellence oral mucositis prevention guidelines, as a treatment modality for oral mucositis prevention in H&N cancer patients. PBM using the THOR laser has received TGA approval for use in prevention and treatment of oral mucositis in Australia.
PARTICIPANTS: post operative oral cancer patients, with clear margins, planned for radiotherapy (50Gy or greater) +/- chemotherapy.
METHODS: participants will receive PBM treatment five times a week throughout the course of their radiotherapy.
EXPECTED OUTCOMES: decrease in incidence and severity of oral mucositis, decrease in pain levels and improved quality of life, less need for analgesia, increased ability to maintain oral intake, less severe trismus, lower rates of hospitalization
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient has provided written informed consent using the PBM PICF
- •Age ≥ 18 years of age at Screening
- •Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological confirmation and no gross residual lymphadenopathy in the planned PBM treatment area
- •Planned treatment with RT or chemoradiotherapy to a dose of ≥ 50 Gy Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1)
- •Intact oral mucosa (no visible ulceration, dehiscence, or active infection)
排除标准
- •Gross macroscopic and/or microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
- •Prior RT to the head and neck including the oral or oropharyngeal mucosa
- •Prior cytotoxic chemotherapy in the last 3 months
- •Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
- •Concurrent administration of cetuximab
- •Known to be pregnant or planning to become pregnant within the trial period
- •Diagnosis of epilepsy
研究组 & 干预措施
Photobiomodulation
Participants will receive photobiomodulation therapy five times a week during the course of their radiation treatment. Upon completion of radiotherapy, if oral mucositis is still present, participants can choose to continue photobiomodulation treatment until oral mucositis has resolved. The frequency of photobiomodulation will be conducted at the discretion of the investigator.
干预措施: photobiomodulation (Device)
结局指标
主要结局
Cumulative incidence and severity of acute oral mucositis
时间窗: Through study completion, an average of 1 year
To describe the effect of PBM on the cumulative incidence and severity of acute OM as defined by the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) for radiation induced mucositis during RT and for 8 weeks following RT.
次要结局
- Function and quality of life (QoL)(Through study completion, an average of 1 year)
- Pain in the oral cavity and throat(Through study completion, an average of 1 year)
- Analgesia intake(Through study completion, an average of 1 year)
- Need for enteral feeding(Through study completion, an average of 1 year)
- Hospitalisation rates(Through study completion, an average of 1 year)
- Trismus(Through study completion, an average of 1 year)