Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- General and specific quality of life.
研究概览
简要总结
The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.
详细描述
Many experts advocate the use of Photobiomodulation (PBM) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. However, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. Finally, recent reviews highlight the importance of determining whether or not the effects of Photobiomodulation therapy 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 three 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the study if they meet the following inclusion criteria:
- •men or women aged 18 years or older and were diagnosed with HNC.
- •chronic xerostomia.
- •received RT in the parotid, submandibular and/or sublingual salivary glands.
- •grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).
- •medical treatment completed and in complete remission.
- •received medical clearance for participation in this study.
- •at least one month passed since the end of RT to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months.
- •no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.
- •and able to access mobile applications or living with someone who has this ability.
排除标准
- •will be as follows:
- •patients with metastases.
- •a score <60 on the Karnofsky Performance Status Scale.
- •contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).
- •other comorbidities such as diabetes and polypharmacy.
- •and retraction of the declaration of consent.
研究组 & 干预措施
Group PBM_1
Energy density 7.5 J / cm2 for group PBM_1
干预措施: Energy density photobiomodulation (7.5) (Device)
Group PBM_2
Energy density 3 J / cm2 for group PBM_2
干预措施: Energy density photobiomodulation (3) (Device)
Placebo Control
The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective glasses) using the same laser device to imitate a real irradiation; however, the device will be turned off and a recording of the emission sounds will be used to give the patient the hearing sensation of the laser therapy.
干预措施: Sham placebo (Device)
结局指标
主要结局
General and specific quality of life.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) 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 comprises 30 items on 5 functional scales, 3 symptom scales, 6 single items and a global health scale measured by a 4-point Likert scale with a total score ranging from 0 to 100. Higher scores on the functional and global health scales indicate better functioning or QoL, respectively, but higher scores on the symptom scales or single items indicate a high level of symptoms. In addition, the specific head and neck module (EORTC QLQ-H\&N35) will be used; this module comprises 35 items on 7 multi-item scales and 11 single items scored from 0 to 100. Higher scores indicate more symptoms.
Oral Health. Severity of xerostomia.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Xerostomia Inventory consists of 11 items (score range 1-5) with a total score ranging from 11 to 55 points to rate the severity of chronic xerostomia. A higher score indicates more severe xerostomia.
Oral Health. Dysphagia.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Eating Assessment Tool questionnaire (EAT-10) consists of 10 items related to swallowing difficulties (score range 0-4, 0=no problem, 4=severe problem), with a total score of 3 or higher indicating dysphagia.
Oral Health. Clinical physical findings (dryness in the mouth).
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
A total of 10 examples of clinical physical findings where each one represents a feature of dryness in the mouth will be administered through the Clinical Oral Dryness Score (CODS). A score of 2 or more indicates significant oral dryness.
Oral Health. Perceived xerostomia.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
A numeric visual analog scale (VAS) will be used with with a grade ranging from 0 (no symptoms) to 10 (the worst possible symptoms).
Oral Health. Degree of mouth opening.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The degree of mouth opening will be determined by the range of motion (ROM) using a sliding caliper, which will measure the maximal interincisal distance in millimeters.
Oral Health. Regional oral dryness.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
Regional Oral Dryness Inventory (RODI) quantifies the severity of dryness at 9 different locations in the oral cavity and is represented by 9 illustrations. Patients will indicate the severity of perceived oral dryness using a 5-point Likert scale (1=none, 5=severe).
Salivary secretion.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The 5-min unstimulated and 5-min stimulated salivary flow rates (SFRs) will be calculated (ml/min) and the volume of each sample will be also calculated (in microlitres). Samples from unstimulated saliva will be used to analyse salivary biomarkers, such as proteins (e.g., antibodies), calcium concentration and pH, using commercial kits.
Salivary gland ultrasound assessment.
时间窗: Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).
The morphology of the parotid and submandibular glands will be assessed using 2D echography (Samsung HM70A echograph) to quantify changes in size in three dimensions.
次要结局
- Functional Performance. Functional capacity.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
- Functional Performance. Mobility/fall risk.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
- Functional Performance. Physical activity level.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
- Mood.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
- Pressure pain threshold.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
- Functional Performance. Perceived fitness status.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
- Sleep quality.(Change from Baseline (at the beginning of the study) to 12 weeks (postintervention) and to 6 months (follow-up).)
研究者
Noelia Galiano-Castillo
Principal Investigator
Universidad de Granada