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Nasopharyngeal CarcinomaNCT05008471

Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study

A study testing Formula nutrition in people with Nasopharyngeal Carcinoma and Radiation Therapy Induced Change, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will present an advanced equipment of tumor nutrition diagnosis and assesment for nasopharyngeal cancer(NPC) radiotherapy patients in nutritional risk screening, evaluation, diagnosis and directing nutritional intervention, aiming to explore the advantages of the whole nutritional management in acute… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Formula nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
1 siteChina
Study dates
26 Apr 2021to 26 Apr 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with nasopharyngeal carcinoma confirmed by histopathology
  • Newly diagnosed patients without distant metastasis
  • Age >18
  • KPS ≥ 70
  • Nasopharyngeal radiotherapy alone or concurrent chemoradiotherapy was planned to be received, andIMRT was used for radiotherapy
  • The patient's blood counts，the lung, liver and renal functions were tolerant to radiotherapy/chemoradiotherapy（ WBC ≥ 4.0*109/L, NE ≥ 2.0*109/L, PLT 100*109/L and Hb≥ 10g/L. AST and ALT ≤ 2.5 *the upper limit（UL） ,TBIL≤1.2*the UL, CRE≤1.2* the UL, and ALP≤5* the UL）. And the ECG should be normal
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  • Good nutritional status,BMI:18~23Kg/ m2, PG-SGA ≤1,NRS 2002<3score
  • No other previous neoplastic diseases, except for cured cervical carcinoma in situ skin basal carcinoma
  • No serious gastrointestinal diseases (moderate and severe duodenal and gastric ulcer, ulcerative colitis, Crohn's disease, etc.)
  • No AIDS and no diabetes
  • Clear mind, no communication barriers, able to answer questions
  • Voluntarily participate and sign the informed consent in person.

Who cannot join

  • Patients with gastrointestinal dysfunction, intestinal obstruction, pyloric obstruction, Acute gastrointestinal bleeding
  • Patients who are allergic to nutritional therapy or have severe allergic constitution
  • Uncontrolled systemic diseases, such as severe liver disease (such as cirrhosis), kidney disease, respiratory diseases and so on.
  • Women who are pregnant or breastfeeding or no contraception and women with positive pregnancy test before receiving treatment
  • Special dietary requirements: such as no having a certain food or a vegetarian.

Trial locations and contacts

1 site in 1 country.

Yunfei Xia, MD contact

13602805461

xiayf@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou, 510000

    Yunfei Xia, MD, 13602805461, xiayf@sysucc.org.cn

    Recruiting

Other trials in China

About this study

This study will present an advanced equipment of tumor nutrition diagnosis and assesment for nasopharyngeal cancer(NPC) radiotherapy patients in nutritional risk screening, evaluation, diagnosis and directing nutritional intervention, aiming to explore the advantages of the whole nutritional management in acute radiation reaction rate, completion rate of radiotherapy, nutritional status, and quality of life for NPC patients.

Read the detailed description

In this study, nutrition intervention was performed in one group of nasopharyngeal carcinoma patients with no nutritional risk during the periperiod of radiotherapy , and the other group with no additional intervention when without nutritional risks, for evaluating the value of overall nutritional management in the periperiod radiotherapy.

Being tested
Formula nutrition
Medical subject headings
Nasopharyngeal Carcinoma, Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formula nutritionDietary supplement

    The target energy of radiotherapy patients is recommended to be 25-30kcal/(kg·d), and the target energy of the intervention group should be increased by an additional 50% daily from the beginning of radiotherapy. Specifically, under the condition of ensuring the daily target energy 14kcal/(kg·d), formula nutrition should be added daily.

Study groups in NCT05008471
Study groupRoleWhat they receive
Intervention groupExperimentalThe recommended target energy for NPC radiotherapy patients is 25-30kcal/(kg·d), in addition，the intervention group begins with an additional 50% daily energy increase during the peri-radiotherapy.
Receives: Dietary Supplement: Formula nutrition
Conventional groupNo interventionUnlike the intervention group,conventional group should be treated according to the consensus of experts on standardized nutrition management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute radiation reactions

    This study mainly includes oral mucosa mucositis, salivary glands injury induced by radiotherapy, laryngoesophageal mucositis referring to The 2020 Expert Consensus on the Standardized Management of Radiation Oncology for nutrition-related radiation injury responses.

    Measured: 12 months

Secondary outcomes (4)

  1. Incidence of decline in nutritional status

    analysis by the clinical nutrition detection analyzer

    Measured: 12 months

  2. Incidence of decline in quality of life scores（QOL）

    It is measured by a standard QOL table,including 12 questions.Each question is 5 points,so there are 60 points and 5 grades(51-60 points, 41-50 points, 31-40 points, 21-30 points,<20 points).A higher score is a better life.

    Measured: 12 months

  3. Self-rating Anxiety screening Scale（GAD-7)

    A GAD-7 table would estimate one's anxiety according to the emotion of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of anxiety, a LOWER score means a normal mind state. Actually,0-4 points is/are no anxiety.5-9 points represent slight anxiety .10-14 are in moderate anxiety.15-27 are severe anxiety,respectively.

    Measured: 12 months

  4. Self-rating Scale for Depression Screening (PHQ-9)

    A PHQ-9 table is a simplified Scale for Depression Screening,it would estimate one's depression emotion according to the mind of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of depression, a LOWER score is equal to a GOOD mind.Actually,0-4 points is/are no depression.5-9 are depressed but not obvious.10-14 are in obvious depression.15-27 are severe depression,respectively.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start26 Apr 2021
  3. Primary completion26 Apr 2022 (estimated)
  4. Study completion26 Apr 2022 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
388 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008471
Sponsor's protocol ID
2020-FXY-487
Status last verified
Aug 2021
First submitted
3 Aug 2021
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Formula nutrition in people with Nasopharyngeal Carcinoma and Radiation Therapy Induced Change, 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 5 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 17 Aug 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunfei Xia, MD (13602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute radiation reactions (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05008471.

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 17 Aug 2021.

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