PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 952
- 试验地点
- 24
- 主要终点
- Duration of feeding tube dependence
研究概览
简要总结
Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT.
Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective.
To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.
详细描述
Swallowing therapy is commonly provided as a behavioral treatment to lessen the risk or severity of dysphagia in head and neck cancer (HNC) patients; however, best practice is not established. This multi-site, international randomized clinical trial (RCT) will compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing interventions in 952 HNC patients undergoing radiotherapy (RT). The 3 study arms represent alternate timing and intensity of swallowing therapy delivered by a speech language pathologist: 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, and 3) PRO-ACTIVE EAT + EXERCISE.
The primary aim of the PRO-ACTIVE trial is to compare the effectiveness of PRO-ACTIVE versus RE-ACTIVE swallowing interventions among patients with HNC planned to undergo RT. We hypothesize that the combined PRO-ACTIVE therapies are more effective than RE-ACTIVE therapy; and, if so, that more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Effectiveness will be measured based on reduced duration of feeding tube dependency as the primary endpoint, an outcome valued equally by patients, caregivers and clinicians.
The secondary aim of the PRO-ACTIVE trial is to compare the relative benefit or harm of swallowing therapy arms on secondary outcomes including videofluoroscopic swallowing evaluations, functional status measures, health status measures, and patient-reported outcomes.
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
- Single (Outcomes Assessor)
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
- •Adults ≥ 18 years of age diagnosed with head and neck malignancy;
- •RT treatment planned for curative intent;
- •Dispositioned to receive external beam radiotherapy dose ≥60 gray to bilateral fields at participating institution;
- •Sufficient fluency in written English, French, Spanish or Simplified Chinese to be able to complete the study patient reported outcome questionnaires
排除标准
- •Distant metastasis at enrollment; or
- •Prior or planned total laryngectomy; or
- •Moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade ≥2 (as graded per central laboratory review)
- •Previously seen by speech language pathologist for swallowing therapy for the current head and neck cancer
- •Diagnosis of second primary non-head and neck cancers in the thorax or the central nervous system at enrollment
- •Head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields
结局指标
主要结局
Duration of feeding tube dependence
时间窗: Baseline - 12 months
Effectiveness will be measured based on duration of feeding tube dependency (count of days from end of radiotherapy to last feeding tube use within the 12-month study period)
次要结局
- The MD Anderson Dysphagia Inventory (MDADI)(Baseline, Week 6/7, 3 months, 12 months)
- Pharyngeal Constriction Ratio (PCR)(Baseline, 3 months, 12 months)
- Medical Outcome of Dysphagia (MOD)(Baseline, 3 months, 12 months)
- EQ-5D-5L(Baseline, 3 months, 12 months)
- Pain Medications(Baseline; Week 6/7, 3 Month, and 12 Months)
- Mouth Opening/Trismus(Baseline; 3 Month and 12 Months)
- Hospitalization/Emergency Department (ED) Presentation(Baseline, Week 6/7, 3 months, 12 months)
- The MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)(Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months)
- Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)(Baseline, 3 months, 12 months)
- Performance Status Scale Head and Neck (PSS-HN)(Baseline, Week 2, Week 4, Week 6/7, 3 months, 12 months)
- Medical History(Baseline, Week 6/7, 3 months, 12 months)
- Penetration-Aspiration Scale (PAS)(Baseline, 3 months, 12 months)
- Peak esophageal opening(Baseline, 3 months, 12 months)
- Cancer Behavior Inventory (CBI-V3)(Baseline, 3 months, 12 months)