Clinical trial NCT02850172: Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer
Official title: Effects of a "Walk, Eat, & Breathe" Nursing Intervention For Patients With Esophageal Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: nutrition
exercise
inspiratory muscle training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 144
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this stratified randomized controlled trial (RCT) is to test the effects of Walk, Eat, \& Breathe on preserving patients' nutritional status, functional walking capacity, pulmonary function, and emotional well-being during the CCRT and surgery course.Additionally, effects to reduce treatment-related complications and length of hospital stay for esophagectomy will be evaluated between experimental and control groups.

Detailed description: Esophageal cancer is a devastating disease with poor prognosis. This is largely due to its rather insidious progression, so most patients were diagnosed with advanced cancer stage. Patients with advanced stage therefore have to be treated with neoadjuvant chemoradiotherapy (CCRT) to shrink the tumor and followed by a curative surgery (i.e., esophagectomy). Patients' nutritional status, functional walking capacity, and emotional well-being are substantially deteriorated, which often increase the incidence of postoperative pulmonary complications, thus the risk of surgical death is greatly increased. To better support patients with esophageal cancer, during this critical treatment course (approximate 4 months in length), we develop a "Walk, Eat, \& Breathe" nursing intervention consisting of nutritional advice, walking exercise, and inspiratory muscle training. The purpose of this stratified randomized controlled trial (RCT) is to test the effects of Walk, Eat, \& Breathe on preserving patients' nutritional status, functional walking capacity, pulmonary function, and emotional well-being during the CCRT and surgery course. Additionally, effects to reduce treatment-related complications and length of hospital stay for esophagectomy will be evaluated between experimental and control groups.

For this three-year stratified RCT, a total of 144 consecutive patients will be enrolled to ensure the power of study. Patients will be eligible for the study if they had histologically documented, locally advanced tumors of the esophagus, defined as American Joint Committee on Cancer (AJCC) stage IIB or higher, were scheduled for neoadjuvant chemoradiotherapy and subsequent curative surgery, and had no contraindication precluding walking. After obtaining the consent, participants will be first stratified by two important covariates \[intake status (oral intake or tube feeding) and tumor location (upper third or middle \& lower third of esophagus)\] and then randomized separately into the experimental or control group, according to computer-generated randomization tables.

Participants in the experimental group will receive "Walk, Eat, \& Breathe" at initiation of CCRT and ends before curative surgery. Participants in the control group received usual care. Participants will undergo measurements at four points in time: before CCRT, after CCRT, before surgery, and 1-month after surgery. Primary endpoints include nutritional status (body weight, lean muscle mass), functional walking capacity (hand-grip strength, 6-min walking distance), pulmonary function (forced vital capacity, forced expiratory volume in 1 second, maximal inspiratory pressure), and emotional well-being (anxiety/depression, quality of life). Secondary endpoints include treatment-related complications and length of hospital stay for esophagectomy. The treatment-related complications will include chemoradiotherapy-related toxicity (i.e., neutropenia, esophagitis), rates of interruptions (i.e., discontinuation, reduction) in chemotherapy or radiotherapy, unplanned hospital admission, incidence of postoperative pulmonary complications, and length of mechanical ventilation for surgery.

Eligibility criteria: Inclusion Criteria:

1. the patient is cognitively capable to understand the trial;
2. locally advanced tumors of the esophagus, defined as American Joint Committee on Cancer (AJCC) stage IIB or higher, were scheduled for neoadjuvant chemoradiotherapy and subsequent curative surgery;
3. the patient is willing to sign the informed consent form.

Exclusion Criteria:

1. age \<20 years;
2. the patient is unable to communicate in the Chinese language; and
3. the patient has contraindications that limit physical activity such as severe cardiac disease, recent myocardial infarction or uncontrolled hypertension.

Primary outcomes:
measure: Body weight
timeFrame: 5 months
measure: Lean muscle mass
timeFrame: 5 months
measure: functional walking capacity
timeFrame: 5 months
measure: hand-grip strength
timeFrame: 5 months
measure: pulmonary function
timeFrame: 5 months
measure: maximal inspiratory pressure
timeFrame: 5 months
measure: anxiety and depression (HADS questionnaire)
timeFrame: 5 months
measure: quality of life (EORTC-QLQ-C30 questionnaire)
timeFrame: 5 months
measure: severity of symptom (QLQ-OES18 questionnaire)
timeFrame: 5 months
Secondary outcomes:
measure: chemoradiotherapy-related toxicity (CTCAE grading system)
timeFrame: 5 months
measure: length of hospital stay
timeFrame: 5 months
measure: treatment interruptions
timeFrame: 5 months
measure: unplanned hospital admission
timeFrame: 5 months
measure: postoperative pulmonary complications
timeFrame: 30 days
measure: length of mechanical ventilation
timeFrame: 30 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Cheryl Chia-Hui Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: