Skip to main content
Clinical Trials/NCT05329688
NCT05329688
Not Yet Recruiting
N/A

The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy

Taipei Medical University WanFang Hospital1 site in 1 country200 target enrollmentDecember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Radiotherapy Side Effect
Sponsor
Taipei Medical University WanFang Hospital
Enrollment
200
Locations
1
Primary Endpoint
BMI
Status
Not Yet Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

Detailed Description

Weight loss is common among cancer patients, and can be attributed to many causes, including mucositis, inability to ingest or absorb adequate calories because of a problem with the alimentary tract, loss of appetite, and metabolic aberrations. Unintentional weight loss may be associated with decreased quality of life (QOL) and a poorer prognosis. Furthermore, for patients who are already in a catabolic state, the increased metabolic demands associated with anticancer treatment (particularly surgery) further worsen the problem. The novel nutrition program might improve the nutrition status and QOL in cancer patients receiving radiotherapy.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 30, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer.
  • Patients need nutrition support treatment
  • Informed consent

Exclusion Criteria

  • Critical patients or life expectancy \< 12 weeks
  • Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
  • Unconscious or psychiatric patients
  • Patients with communication problems

Outcomes

Primary Outcomes

BMI

Time Frame: Week 0, 12

Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.

Quality of Life (QOL)

Time Frame: Week 0, 12

The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.

albumin

Time Frame: Week 0, 12

level of serum albumin

risk of malnutrition

Time Frame: Week 0, 12

Nutrition Risk Screening 2002 is used to assess the risk of malnutrition.

Secondary Outcomes

  • physical function status(Week 0, 12)
  • Knowledge-Attitude-Practice(Week 0, 12)

Study Sites (1)

Loading locations...

Similar Trials