Radiotherapy Side EffectNCT05329688
Nutrition Education Program for Cancer Patients Receiving Radiotherapy
A study testing novel nutrition program in people with Radiotherapy Side Effect and Nutrition Related Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiotherapy Side Effect, Nutrition Related Cancer
- What is being tested?
- novel nutrition program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Szu-Yuan Wu
Taipei, Please Select, 116
Szu-Yuan Wu, 0910603955, szuyuanwu5399@gmail.com
About this study
Official title: The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy
Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy
Read the 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.
- Conditions
- Radiotherapy Side Effect, Nutrition Related Cancer
- Being tested
- novel nutrition program
- Keywords
- nutrition, radiotherapy, cancer patients
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel nutrition programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: novel nutrition program |
| 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. Receives: Procedure: novel nutrition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of malnutrition
Nutrition Risk Screening 2002 is used to assess the risk of malnutrition.
Measured: Week 0, 12
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.
Measured: Week 0, 12
albumin
level of serum albumin
Measured: Week 0, 12
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.
Measured: Week 0, 12
Secondary outcomes (2)
physical function status
Using Eastern Cooperative Oncology Group to assess the physical function.
Measured: Week 0, 12
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.
Measured: Week 0, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind (Participant)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asia University
- Responsible party
- Sponsor
- Investigators
- Szu-Yuan Wu, Study director, Asia University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329688
- Sponsor's protocol ID
- IRB110-196-A
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study completed
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT05329688
- Acronym / sponsor ID
- IRB110-196-A
- Conditions
- Radiotherapy Side Effect, Nutrition Related Cancer
- Keywords
- nutrition, radiotherapy, cancer patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Collaborators
- Asia University
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blind (Participant)
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: novel nutrition programNovel 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. |
| Arm B | Active comparator | Procedure: novel nutrition programRoutine nutrition education Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novel nutrition programGive 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. | Procedure or surgery | Arm A, Arm B |
Primary outcome
risk of malnutrition
Time frame: Week 0, 12
Nutrition Risk Screening 2002 is used to assess the risk of malnutrition.
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.
albumin
Time frame: Week 0, 12
level of serum albumin
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.
2 secondary outcomes
physical function status
Time frame: Week 0, 12
Knowledge-Attitude-Practice
Time frame: Week 0, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Yes. study completed
Related trials for Radiotherapy Side Effect
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-Yuan Wu study director
Asia University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel nutrition program in people with Radiotherapy Side Effect and Nutrition Related Cancer, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Szu-Yuan Wu (+886910603955, szuyuanwu5399@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of malnutrition (time frame: Week 0, 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.