Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Xerostomia severity.
研究概览
简要总结
Patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month Photobiomodulation (PBM) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands).
详细描述
The use of PBM therapy in survivors with head and neck cancer may be an effective treatment to improve xerostomia and hyposalivation as side effects of radiotherapy. Although there is some scientific evidence on its benefits during or after radiotherapy, it is not sufficient to establish it as an effective treatment. For these reasons, studies of higher methodological quality such as randomized controlled trials, are needed. This study aims to demonstrate the benefits of PBM therapy on xerostomia and hyposalivation in survivors with head and neck cancer undergone radiotherapy, and whether the effects are maintained after a follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants who meet the inclusion and exclusion criteria will be randomized to one of the two study groups using a random number generation program (www.randomizer.org). The randomization sequence will be prepared by a member external to the investigation to respect the masking in terms of randomization of the participants, thus reducing the risk of bias during the evaluations. Therefore both patients and evaluator will be masked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with head and neck cancer
- •Persistent xerostomia after radiotherapy
- •≥18 years
- •Irradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual)
- •Grade 3 for dry mouth in Common Terminology Criteria for Adverse Events, CTCAE (version 5.0)
- •Have completed medical treatment with full response (complete remission) and receive medical clearance for participation.
- •At least one month after radiotherapy completion, to reflect the possible presence of oral mucositis (sores) and/or radiodermatitis (inflammation) that limits adherence to treatment
- •No use of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers or herbs) to prevent or treat xerostomia before inclusion in the study, OR constant usage (do not change type and dosage) during 2 months before inclusion in the study
排除标准
- •Relapse or metastasis
- •Karnofsky activity scale <60
- •Contraindications to PBM therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy)
- •Patients with other comorbidities such as diabetes o polymedication
结局指标
主要结局
Xerostomia severity.
时间窗: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Xerostomia Inventory consists of 11 items, the total score ranges from 11 to 55 points, and represents the severity of chronic xerostomia. Higher scores mean a worse outcome.
Nutritional and oral status.
时间窗: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome.
Salivary flow rate.
时间窗: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Determines the amount of unstimulated saliva (ml) produced in 3 minutes. Higher amount means less hyposalivation.
General and specific quality of life in patients with head and neck cancer.
时间窗: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 assesses overall quality of life. It is a valid questionnaire and widely used in cancer population. High score for functional scales and global health status represents better outcomes. Higher symptom scales/items scores mean a worse outcome. In addition, its specific head and neck module (EORTC QLQ-H\&N35) where higher symptom scales/items scores mean a worse outcome.
Maximum mouth opening.
时间窗: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility.
次要结局
- Fitness Scale.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
- Physical activity level.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
- Pressure pain threshold.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
- Mood status.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
- Functional capacity.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
- Quality of sleep.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
- Risk of falls.(Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).)
研究者
Noelia Galiano-Castillo
Principal Investigator
Universidad de Granada