Nutrition Education Program for Cancer Patients Receiving Radiotherapy

Sponsor
Taipei Medical University WanFang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05329688
Collaborator
Asia University (Other)
200
1
2
35.9
5.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: novel nutrition program
N/A

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
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
single blind (Participant)single blind (Participant)
Masking:
Single (Participant)
Masking Description:
single blind (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

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.

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.

Active Comparator: Arm B

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

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.

Outcome Measures

Primary Outcome Measures

  1. risk of malnutrition [Week 0, 12]

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

  2. BMI [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.

  3. albumin [Week 0, 12]

    level of serum albumin

  4. Quality of Life (QOL) [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.

Secondary Outcome Measures

  1. physical function status [Week 0, 12]

    Using Eastern Cooperative Oncology Group to assess the physical function.

  2. Knowledge-Attitude-Practice [Week 0, 12]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Szu-Yuan Wu Taipei Please Select Taiwan 116

Sponsors and Collaborators

  • Taipei Medical University WanFang Hospital
  • Asia University

Investigators

  • Study Director: Szu-Yuan Wu, Asia University, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT05329688
Other Study ID Numbers:
  • IRB110-196-A
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Medical University WanFang Hospital

Study Results

No Results Posted as of Apr 15, 2022