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临床试验/NCT02385929
NCT02385929已完成不适用

Bimodal Pre-habilitation Program to Improve Symptom Control After Treatment for Head and Neck Cancer

Irene Wessel4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
4
主要终点
Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES).

研究概览

简要总结

The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.

详细描述

Although the potential negative impact of head and neck cancer (HNC) and its treatment on eating ability and quality of life is well documented there is no evidence based and standardized rehabilitation program available for Danish patients affected by HNC while going through radiotherapy (with or without concurrent chemotherapy). This study proposal is based on a thorough literature review on HNC treatment and late effects, and interventions targeting dysphagia and physical functioning.

Traditionally, rehabilitation is initiated when loss of function is already established. Emerging evidence suggests, however, that it can be of benefit to the patient to initiate an early rehabilitation process (prehabilitation) starting before initiation of treatment and during treatment. Prehabilitation aims to enhance pre-treatment functional capacity for better tolerance of treatment, facilitate general recovery, and prevent development of functional impairment or reduce the extent of these problems in a long-term perspective. HNC patients have a unique set of functional challenges such as pre- and post-treatment dysphagia, pain, and weight loss and often also high baseline levels of alcohol and tobacco consumption. In addition, studies have shown that only 31 % and 9 % of HNC patients are meeting public health guidelines for physical activity before and after diagnosis, respectively, and that weight loss in HNC patients treated with chemoradiation begin after only 1 week of therapy. Most of the weight loss was lean body mass (LBM) rather than fat loss. Loss of LBM is significantly associated with physical performance and increased functional dependence. The level of physical activity typically decreases significantly during treatment.

Dysphagia is considered the most prominent complication to HNC and its treatment, affecting physical function and quality of life. Post treatment dysphagia occurs in a significant proportion of patients and results from multiple factors such as xerostomia, taste loss, decreased sensory function, fibrosis and trismus. Disuse of swallowing muscles due to acute radiation effects or tube feeding can contribute to decline in swallowing function. Often, difficulties in swallowing and mouth opening are presenting features of HNC even at the time of diagnosis. To reduce these problems, patients may do a series of exercises before and during treatment to promote strength, mobility, and endurance of base of tongue, pharyngeal constrictors, and suprahyoid strap muscles. Although no definitive trials have yet been carried out, small randomized controlled trials (RCTs) and observational studies investigating pre-treatment swallowing and/or mouth opening exercise programs show promising benefits. Further, the few studies of resistance and cardio training on functional capacity in HNC patients are generally promising with medium to large effects on fatigue and physical function measures. For weight loss it seems as if progressive resistance training (PRT) is able to almost reverse the loss of LBM in HNC patients.

Generally studies on swallowing therapy for HNC patients have relied greatly on self-practice, and thus report low compliance. In view of this knowledge the investigators determine that there is a need for studies that include patients with HNC undergoing (chemo)radiation therapy focusing on i) prevention of dysphagia and loss of muscle strength and ii) improvement of compliance to mouth opening and swallowing exercises.

The purpose of the SYNK study is a randomized design to test the effect of theory based intervention on eating dysfunctions secondary to radiation treatment for HNC. The SYNK intervention consists of: i) individual instructions in swallowing and mouth opening exercises 3 days per week by occupational therapist throughout radiotherapy, ii) progressive resistance training twice weekly by physiotherapist, either individually or group based, throughout radiotherapy, iii) daily home-based swallowing and mouth opening exercises from beginning of treatment until 2 months after end-of-treatment (self-practice), and iv) weekly follow-up phone contacts with occupational therapists from end-of-treatment and 2 months onwards.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Histological proven cancer in one or more of the following areas: larynx, hypopharynx, oropharynx, cavi oris, or unknown primary tumor
  • Set to curative radiotherapy with or without concurrent chemotherapy for treatment of cancer in the head and neck region in accordance with the Danish Head and Neck Cancer Group (DAHANCA) guidelines
  • Fully self-reliant
  • Danish skills, oral and written
  • Informed consent

排除标准

  • Previously received treatment for head and neck cancer (radiotherapy, chemotherapy and/or surgery).
  • Pregnancy
  • ECOG performance status > 2
  • Presence of psychological-, family-, sociological- or geographical issues that could prevent the patient from completing the intervention
  • Simultaneous or previous illness or conditions that could prevent the patient's ability to complete the intervention.

结局指标

主要结局

Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES).

时间窗: Baseline, 14 weeks and 58 weeks. Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.

To investigate the change in swallowing function among patients in intervention- and the control group from baseline to 14 and 58 weeks follow up and the difference in change between intervention - and the control group.

次要结局

  • Pain by numerical rating scale (NRS)(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Level of oral intake by Functional Oral Intake Scale (FOIS)(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Weight loss by body weight(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Depression by Major Depression Inventory (MDI)(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Anxiety by Symptom Check List (SCL-92) Anxiety subscale(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Level of fatigue by the EORCT QLQ-C30 3-point fatigue subscale.(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Subjective symptoms of dysphagia by Eating Assessment Tool (EAT-10)(Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.)
  • Dysphagia related quality of life by M.D. Anderson Dysphagia Inventory (MDADI)(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Physical strength by 30 seconds Sit to Stand (STS) test.(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Maximal Interincisal Distance (MID) by Therabite Range of Motion (ROM) scale(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Performance Status by Eastern Cooperative Oncology Group (ECOG) performance scale(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)
  • Health related quality of Life by the European Organisation for Research and Treatment of Cancer (EORCT) Quality if Life Questionnaire (QLQ)-30 and EORCT QLQ - H&N35(baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.)

研究者

发起方
Irene Wessel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Irene Wessel

Consultant, ph.d., associate professor

Rigshospitalet, Denmark

研究点 (4)

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