Nutrition Education Program for Cancer Patients Receiving Radiotherapy

Radiotherapy Side Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05329688
• Other study ID #: IRB110-196-A
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2022
• Source: Taipei Medical University WanFang Hospital
• Contact: Szu-Yuan Wu
• Phone: +886910603955
• Email: szuyuanwu5399[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer.

2. Patients need nutrition support treatment

3. Informed consent

Exclusion Criteria:

1. Critical patients or life expectancy < 12 weeks

2. Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.

3. Unconscious or psychiatric patients

4. Patients with communication problems

Related Conditions & MeSH terms

• Nutrition Related Cancer
• Radiotherapy Side Effect

Intervention

Procedure:
• novel nutrition program
Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.

Locations

Country	Name	City	State
Taiwan	Szu-Yuan Wu	Taipei	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital	Asia University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of malnutrition	Nutrition Risk Screening 2002 is used to assess the risk of malnutrition.	Week 0, 12
Primary	BMI	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.	Week 0, 12
Primary	albumin	level of serum albumin	Week 0, 12
Primary	Quality of Life (QOL)	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.	Week 0, 12
Secondary	physical function status	Using Eastern Cooperative Oncology Group to assess the physical function.	Week 0, 12
Secondary	Knowledge-Attitude-Practice	Knowledge Scale composes of 10 questions and 10 scores for each question. Attitude and Practice Scale have 5 questions. Each question is rated as A?B?C. A represents 20 score and B is 10 score.	Week 0, 12