MalnutritionNCT04810936
Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy
A study testing oral nutritional supplements in people with Malnutrition and Nasopharyngeal Carcinoma, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Malnutrition, Nasopharyngeal Carcinoma
- What is being tested?
- oral nutritional supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2019to 31 Dec 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed nasopharyngeal carcinoma (NPC).
- The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition).
- Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT).
- Age ≥ 18 years and < 75 years.
- Performance status (PS) score 0-1.
- NRS2002<3 .
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- Blood regular test should be satisfied the following conditions: white blood cell count ≥3.5×109/L， Neutrophil count ≥1.5×109/L，platelet count ≥100×109/L，hemoglobin ≥10g/L
- Liver and kidney functions test should be satisfied the following conditions: aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value, bilirubin < 1.2 times the upper limit of normal value, creatinine < 1.2 times the upper limit of normal value, and alkaline phosphatase < 5 times the upper limit of normal value.
- Could complete required oral nutrition, questionnaire survey and follow-up.
- Signed informed consent voluntarily.
Who cannot join
- Had a history of head and neck radiotherapy.
- Known allergic reaction to any component of ONS, or severe allergic constitution.
- With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on).
- Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction).
- Pregnancy and lactation.
- Other conditions that the investigators consider as inappropriate for enrolling into this study.
- Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yi Pan, Dr., +86-020-83827812, panyiff01@163.com
About this study
Official title: A Randomized Controlled Trial of an Early Oral Nutritional Supplements Intervention Versus a Conventional Nutritional Intervention in Patients With Locally Advanced Nasopharyngeal Carcinoma Undergoing Concurrent Chemoradiotherapy
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.
Read the detailed description
Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy.
Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy.
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.
- Conditions
- Malnutrition, Nasopharyngeal Carcinoma
- Being tested
- oral nutritional supplements
- Keywords
- Nasopharyngeal carcinoma, malnutrition, Early nutritional intervention, chemoradiotherapy
- Medical subject headings
- Malnutrition, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementsDietary supplement
Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Early ONS intervention group | Experimental | Patients in early ONS intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy) and ONS intervention in the beginning of radiotherapy. The ONS is prescribed to increase oral intake of patients and to ensure total energy supply is more than 30 kcal/kg/day and protein intake more than 1.2 g/kg/day. Receives: Dietary Supplement: oral nutritional supplements |
| Standard nutrition intervention group | No intervention | Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who lose >5% of initial body weight
Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy *100 %.
Measured: 7 weeks
Secondary outcomes (11)
Weight loss at the last day of radiotherapy
The changes of weight at the last day of radiotherapy
Measured: 7 weeks
Weight loss at the end of 4th week
The changes of weight at the end of 4th week
Measured: 11 weeks
Patient-generated Subjective Global Assessment (PG-SGA) at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy
PG-SGA at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy
Measured: 11 weeks
Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy
Incidence of radiation induced grade 3-4 mucositis at the end of 4th week and the last day of radiotherapy
Measured: 7 weeks
Incidence of any grade 3-4 side-effect (CTCAE 4.03).
Incidence of any grade 3-4 side-effect induced by radiotherapy or chemotherapy during chemoradiotherapy
Measured: 7 weeks
Incidence of prolonged radiation treatment time caused by side-effects
Incidence of prolonged radiation treatment time caused by chemoradiation related side-effects. Prolonged radiation treatment time is defined as the overall treatment time is longer than plan
Measured: 7 weeks
Days prolonged more than planed treatment time caused by side-effects
Days prolonged more than planed treatment time caused by chemoradiation related side-effects
Measured: 7 weeks
Incidence of unplanned hospitalization in 3 months after radiation
Incidence of unplanned hospitalization in 3 months after radiation. Unplanned hospitalization is defined as hospitalization caused by chemoradiotherapy related side effects
Measured: 5 months
The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
Measured: 5 months
The treatment time of parenteral nutrition (PN) treatment
PN should be started if enteral nutrition (EN) is anticipated (60% of estimated energy expenditure) for more than 10 days. The treatment time of PN should be recorded
Measured: 5 months
The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H\&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start26 Jul 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI PAN, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810936
- Sponsor's protocol ID
- GDREC2018296H(R1)
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Early Oral Nutritional Supplements Intervention Versus a Conventional Nutritional Intervention in Patients With Locally Advanced Nasopharyngeal Carcinoma Undergoing Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT04810936
- Acronym / sponsor ID
- GDREC2018296H(R1)
- Conditions
- Malnutrition, Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, malnutrition, Early nutritional intervention, chemoradiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Mar 2021 (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.
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.
Detailed description
Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy.
Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy.
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early ONS intervention group | Experimental | Dietary Supplement: oral nutritional supplementsPatients in early ONS intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy) and ONS intervention in the beginning of radiotherapy. The ONS is prescribed to increase oral intake of patients and to ensure total energy supply is more than 30 kcal/kg/day and protein intake more than 1.2 g/kg/day. |
| Standard nutrition intervention group | No intervention | –Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed nasopharyngeal carcinoma (NPC).
- The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition).
- Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT).
- Age ≥ 18 years and < 75 years.
- Performance status (PS) score 0-1.
Key exclusion criteria (7 listed)
- Had a history of head and neck radiotherapy.
- Known allergic reaction to any component of ONS, or severe allergic constitution.
- With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on).
- Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction).
- Pregnancy and lactation.
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 |
|---|---|---|
| oral nutritional supplementsOral nutritional supplements is usually administrated to improve nutritional status in cancer patients. | Dietary supplement | Early ONS intervention group |
Primary outcome
The percentage of patients who lose >5% of initial body weight
Time frame: 7 weeks
Assess body weight at the end of radiotherapy (the weight at the end of radiotherapy - the weight at the beginning of radiotherapy) / the weight at the beginning of radiotherapy *100 %.
11 secondary outcomes
Weight loss at the last day of radiotherapy
Time frame: 7 weeks
Weight loss at the end of 4th week
Time frame: 11 weeks
Patient-generated Subjective Global Assessment (PG-SGA) at the end of the 2nd week, 4th week, the last day of radiotherapy and 1 month after radiotherapy
Time frame: 11 weeks
Incidence of radiation induced grade 3-4 mucositis (CTCAE 4.03) at the end of 4th week and the last day of radiotherapy
Time frame: 7 weeks
Incidence of any grade 3-4 side-effect (CTCAE 4.03).
Time frame: 7 weeks
Incidence of prolonged radiation treatment time caused by side-effects
Time frame: 7 weeks
Days prolonged more than planed treatment time caused by side-effects
Time frame: 7 weeks
Incidence of unplanned hospitalization in 3 months after radiation
Time frame: 5 months
The changes of QOL-C30 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
Time frame: 5 months
The treatment time of parenteral nutrition (PN) treatment
Time frame: 5 months
The changes of EORTC Quality of LifeQuestionnaire (QLQ)-H&N35 at the end of radiation, the 1st and the 3rd month after radiation as compared with the beginning of radiation
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutritional supplements in people with Malnutrition and Nasopharyngeal Carcinoma, run by Guangdong Provincial People's Hospital 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 10 inclusion and 7 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 23 Mar 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 Yi Pan, Prof. (+86020-83827812, panyiff01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who lose >5% of initial body weight (time frame: 7 weeks). 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 23 Mar 2021.