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NCT Number: NCT01952210

Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient

In this randomized pilot study, a nutritional consultation combining exercise program is planned for 25 locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation. The purpose of this study is to determine the effects of nutritional and exercise intervention in locally advanced esophageal cancer patients undergoing neoadjuvant chemoradiation.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

Patients with esophageal cancer are often malnourished at presentation due to the primary symptom of dysphagia. Treatments for esophageal cancer are commonly multimodal, incorporating polychemotherapy, radiotherapy and surgery. These treatments frequently cause or exacerbate poor nutritional status. Recent literature has proved that malnutrition is associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, worse quality of life and lower survival rate. The aim of this study was to investigate the effectiveness of an intensive nutritional consultation and exercise program on nutritional status and outcomes in patients undergoing chemoradiation for esophageal cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of locally advanced esophageal cancer, neoadjuvant chemoradiation is indicated
  • Informed consent signed

Exclusion criteria

  • stage IV, underwent palliative chemotherapy or radiotherapy patient
  • clinically significant cardiac or pulmonary disease
  • Unable to walk or exercise

Treatment and study plan

nutritional consultation and exercise program

Behavioral

The protocol involved 20-30 minutes of individual-based nutrition consultation every week during the 8-week chemoradiation therapy. The exercise program consisted of upper extremity muscle training and walking exercise at 45%-65% of maximal heart rate reserve, 3 times per week, 20-30 minutes per session.

Other names: nutritional consultation

Usual Care

Behavioral

pre-CCRT education included self-care during CCRT and body weight maintenance

Other names: pre-CCRT education

Primary outcomes

  1. General nutritional status

    Time frame: 10 weeks

    Measure tools included patient-generated-subjective global assessment score, hand-grip strength, body weight, body composition analysis, and 6-mim walk test were used to define the general nutritional status of esophageal cancer patient. The study measures were chosen on the basis that they had been utilized in previous cancer trials examining the effects of various interventions on weight loss, endurance and strength, and simple enough to be administered in the clinical setting.

Secondary outcomes

  1. Treatment tolerance

    Time frame: 10 weeks

    To evaluate the treatment tolerance, the following data were assessed: number of treatment breaks or delay for toxicity, grading of acute chemoradiation-related toxicity, number of unplanned hospitalization for adverse effects.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Effectiveness of a Nutritional Consultation and Exercise Program in Esophageal Cancer Patient Receiving Neoadjuvant Chemoradiation.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2013
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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