Nasopharyngeal CarcinomaNCT05834712
Patients With Stage III-IVa Nasopharyngeal Carcinoma With or Without a Mobile Medical Platform Full-course Nutritional Intervention
A study testing mobile platform or not mobile platform in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- mobile platform or not mobile platform
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2022to 24 Sep 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Voluntarily participate and sign the informed consent in writing.
- 2.Stage III-IVa (AJCC 8th edition staging) .
- 3.Received induction chemotherapy + concurrent chemoradiotherapy .
- 4.18-70 years old.
- 5.Pathologically diagnosed with non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, WHO type II or III).
- 6.No previous anti-tumor therapy .
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- 7.ECOG score 0-1.
- 8.Ensure contraception during the study period.
- 9.Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
- 10. Liver function: ALT, AST < 2.5 times the upper limit of normal (ULN), total bilirubin < 2.0 × ULN.
- 11. Renal function: serum creatinine <1.5×ULN.
- 12.Able and willing to use a mobile phone or tablet to fill in the electronic scale.
Who cannot join
- 1.Received antitumor therapy in the past.
- 2. The pathology was keratinizing squamous cell carcinoma (WHO type I).
- 3.Pregnant women who are in the reproductive period and have not taken effective contraceptive measures.
- 4. Has suffered from other malignant tumors (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
- 5.Patients with significantly low heart, liver, lung, kidney and bone marrow functions.
- 6.Serious, uncontrolled medical diseases and infections.
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- 7.Concurrent use of other experimental drugs or other clinical trials.
- 8. Refused or unable to sign the informed consent to participate in the trial.
- 9.Those who have other contraindications to treatment.
- 10.Persons with personality or mental disorders, no capacity for civil conduct or limited capacity for civil conduct.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: A Randomized, Controlled, Phase II Clinical Study on the Improvement of Malnutrition in Patients With Stage III-IVa Nasopharyngeal Carcinoma With or Without the Use of Mobile Medical Platform Full-course Nutritional Intervention
To study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional rehabilitation management.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- mobile platform or not mobile platform
- Keywords
- Nasopharyngeal Carcinoma, mobile platform, nutritional intervention, radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile platform or not mobile platformDevice
Intervention using WeChat
| Study group | Role | What they receive |
|---|---|---|
| Mobile Platform Intervention Group | Experimental | The mobile platform is used to evaluate the nutrition of patients 2 weeks after the first course of induction chemotherapy, before radiotherapy, during radiotherapy, after radiotherapy, and 1 month after radiotherapy. The doctor pushes individualized nutrition education, oral advice, medication advice, etc. . Receives: Device: mobile platform or not mobile platform |
| Non-mobile Platform Intervention Group | Active comparator | Nutritional assessment of patients was performed at 2 weeks after 1 course of induction chemotherapy, before radiotherapy, during radiotherapy, at the end of radiotherapy, and at 1 month after the end of radiotherapy. Receives: Device: mobile platform or not mobile platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Differences in the proportion of patients who lost >10% of their body weight at 1 month after chemoradiotherapy between experimental and control groups
Measured: 1 month after chemoradiotherapy
Secondary outcomes (5)
weight loss >10%
Differences in the proportion of patients who lost >10% of their body weight at the end of chemoradiotherapy between experimental and control groups
Measured: at the end of chemoradiotherapy
weight loss >20%
Differences in the proportion of patients who lost >20% of their body weight at the end of chemoradiotherapy between experimental and control groups
Measured: at the end of chemoradiotherapy
ncidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Measured: at the end of chemoradiotherapy
change of PG-SGA
Scored Patient-Generated Subjective Global Assessment (PG-SGA).It consists of two parts: the patient's self-assessment part and the medical staff's assessment part. The specific contents include seven aspects, including body weight, food intake, symptoms, activity and physical function, the relationship between disease and nutritional needs, metabolic needs, and physical examination. The first 4 Each aspect is evaluated by the patient himself, and the last three aspects are evaluated by the medical staff. The overall evaluation includes qualitative evaluation and quantitative evaluation.
Measured: 1 month after chemoradiotherapy
change of NRS2002
The outstanding advantage of NRS2002 is that it can predict the risk of malnutrition, and can proactively and dynamically judge the changes in the nutritional status of patients, which is convenient for timely feedback of the nutritional status of patients, and provides evidence for adjusting nutritional support programs. It is a better nutritional risk screening tool.
Measured: 1 month after chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start11 May 2022
- Primary completion24 Sep 2023
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834712
- Sponsor's protocol ID
- 2021-FXY-332
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase II Clinical Study on the Improvement of Malnutrition in Patients With Stage III-IVa Nasopharyngeal Carcinoma With or Without the Use of Mobile Medical Platform Full-course Nutritional Intervention
- ClinicalTrials.gov ID
- NCT05834712
- Acronym / sponsor ID
- 2021-FXY-332
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, mobile platform, nutritional intervention, radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 28 Apr 2023 (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.
To study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional rehabilitation management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Platform Intervention Group | Experimental | Device: mobile platform or not mobile platformThe mobile platform is used to evaluate the nutrition of patients 2 weeks after the first course of induction chemotherapy, before radiotherapy, during radiotherapy, after radiotherapy, and 1 month after radiotherapy. The doctor pushes individualized nutrition education, oral advice, medication advice, etc. . |
| Non-mobile Platform Intervention Group | Active comparator | Device: mobile platform or not mobile platformNutritional assessment of patients was performed at 2 weeks after 1 course of induction chemotherapy, before radiotherapy, during radiotherapy, at the end of radiotherapy, and at 1 month after the end of radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1.Voluntarily participate and sign the informed consent in writing.
- 2.Stage III-IVa (AJCC 8th edition staging) .
- 3.Received induction chemotherapy + concurrent chemoradiotherapy .
- 4.18-70 years old.
- 5.Pathologically diagnosed with non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, WHO type II or III).
Key exclusion criteria (10 listed)
- 1.Received antitumor therapy in the past.
- 2. The pathology was keratinizing squamous cell carcinoma (WHO type I).
- 3.Pregnant women who are in the reproductive period and have not taken effective contraceptive measures.
- 4. Has suffered from other malignant tumors (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
- 5.Patients with significantly low heart, liver, lung, kidney and bone marrow functions.
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 |
|---|---|---|
| mobile platform or not mobile platformIntervention using WeChat | Device | Mobile Platform Intervention Group, Non-mobile Platform Intervention Group |
Primary outcome
weight loss
Time frame: 1 month after chemoradiotherapy
Differences in the proportion of patients who lost >10% of their body weight at 1 month after chemoradiotherapy between experimental and control groups
5 secondary outcomes
weight loss >10%
Time frame: at the end of chemoradiotherapy
weight loss >20%
Time frame: at the end of chemoradiotherapy
ncidence rate of adverse events (AEs)
Time frame: at the end of chemoradiotherapy
change of PG-SGA
Time frame: 1 month after chemoradiotherapy
change of NRS2002
Time frame: 1 month after chemoradiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile platform or not mobile platform in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
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 12 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jan 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 1 month after chemoradiotherapy). 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 27 Jan 2025.