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Clinical Trials/NCT05329688
NCT05329688Not yet recruitingNot Applicable

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 enrollmentStarted: December 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
200
Locations
1
Primary Endpoint
BMI

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

single blind (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Arm A

Experimental

Novel nutrition program :

Give nutrition health education every week and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.

Intervention: novel nutrition program (Procedure)

Arm B

Active Comparator

Routine nutrition education Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.

Intervention: novel nutrition program (Procedure)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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