Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors.
SECONDARY OBJECTIVES:
I.To estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia.
II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors.
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
- 否
入选标准
- •Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade >= 2 dysphagia on Modified Barium Swallow (MBS) >= 2 years after curative-intent radiotherapy for head and neck cancer
- •Grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) fibrosis
- •Willing and able to return for 10 sessions over 6 weeks of therapy
排除标准
- •Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment
- •Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment
- •History of subtotal or total glossectomy or total laryngectomy
- •Functionally limiting cardiac, pulmonary, or neuromuscular disease
- •Current tracheostomy
研究组 & 干预措施
Supportive Care (manual therapy)
Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.
干预措施: Manual Therapy (Procedure)
结局指标
主要结局
Feasibility
时间窗: Up to 12 weeks
Will be determined by completion rate. Completion rate will be defined by completion of the 6 week clinical manual therapy (MT) program without withdrawing and attending a minimum of 2 sessions and the post-treatment assessment. Session attendance will be monitored separately to assess adherence and fidelity. Will summarize fidelity and adherence to the standard MT protocol using quantitative and qualitative methods.
Incidence of adverse events
时间窗: Up to 12 weeks
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events will be tabulated and will be monitored by the trial Data Safety Monitoring Board.
Feasibility Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
时间窗: 6 weeks of MT
To determine feasibility of Manual Therapy (MT). Participants successfully completing the full 6 weeks of MT therapy.
Safety of Manual Therapy for Treatment of Fibrosis-related Dysphagia in Head and Neck Cancer Survivors
时间窗: 6 weeks of MT
To determine safety of Manual Therapy (MT). Participants who did not experience any adverse event while on study.
次要结局
- Lingual and jaw range of motion (ROM)(Up to 12 weeks)
- Symptom burden(Up to 12 weeks)
- Lymphedema/fibrosis staging(Up to 12 weeks)
- Performance status(Up to 12 weeks)
- Soft tissue fibrosis(Up to 12 weeks)
- Efficacy and durability of response(Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks))
- Swallowing function and physiology(Baseline to 6 weeks (after manual therapy))
- Swallowing-related quality of life(Up to 12 weeks)
- Improvement in tongue innervation on Electromyography (EMG) findings(Baseline to 6 weeks (after manual therapy))
- Efficacy and Durability of Response(Up to 12 weeks; baseline, after manual therapy (6 weeks), and after home program wash-out period (6 weeks))
- Soft Tissue Fibrosis(Up to 12 weeks)
- Swallowing Function and Physiology(Baseline to 6 weeks (after manual therapy))
- Lingual and Jaw Range of Motion (ROM)(Up to 12 weeks)
- Swallowing-related Quality of Life(Up to 12 weeks)
- Symptom Burden(Up to 12 weeks)
- Lymphedema/Fibrosis Staging(Up to 12 weeks)
- Performance Status(Up to 12 weeks)
- Improvement in Tongue Innervation on Electromyography (EMG) Findings(Baseline to 6 weeks (after manual therapy))