Nasopharyngeal CarcinomaPhase 2/3NCT03344068
Early and Whole Course Nutritional Support by Nutren® Optimum During IMRT for Nasopharyngeal Carcinoma
A Phase 2/3 study testing Radiotherapy, Chemotherapy and Nutren® Optimum in people with Nasopharyngeal Carcinoma and Nutritional Support, run by Sun Yat-sen University at 1 site in China.
Trial summary
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Nutritional Support
- What is being tested?
- Radiotherapy, Chemotherapy and Nutren® Optimum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Mar 2021
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed and previously untreated nasopharyngeal carcinoma without distant metastasis.
- Age ≥ 18 years and < 65 years.
- Karnofsky performance status (KPS) score ≥ 70.
- Planned to receive radiotherapy alone or concurrent chemoradiotherapy, with intensity-modulated radiation therapy (IMRT).
- Adequate normal organ function.
- Well nutritional status, with PG-SGA≤1 score and NRS2002<3 scores.
- Without other severe diseases.
- Signed informed consent voluntarily, and could complete required oral nutrition, questionnaire survey and follow-up.
Who cannot join
- Known allergic reaction to any component of Nutren® Optimum, or severe allergic constitution.
- Poor compliance.
- Other conditions that the investigators consider as inappropriate for enrolling into this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: A Single Center, Open-label, Randomized Controlled Clinical Trial on the Early and Whole Course Nutritional Support by Nutren® Optimum During Intensity Modulated Radiation Therapy for Nasopharyngeal Carcinoma
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially combined with chemotherapy. Significant weight loss caused by Oral mucositis will keep patients in worse nutrition status and then to decline immune function, hematopoietic function and repair function, which will influence the patient's quality of life, reduce the tolerance of treatment, and affect treatment effect. At present, the guidelines at home and abroad more and more emphasize that early nutrition treatment and intervention before systemic malnutrition, also suggest nutrition treatment and intervention at the same time of anti-tumor treatment. First choice of nutritional intervention is oral nutrition supplement. Nutren® Optimum has a higher protein ratio and 50% of the protein sources were lactalbumin and 50% casein. Lactalbumin is a high-quality protein, with the highest nutritional value among a variety of proteins. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin. Nutren® Optimum also contains dietary fiber, vitamin E, monounsaturated fat, L-carnitine, 30 kinds of vitamins and minerals and other nutrients, which can provide a comprehensive and balanced nutrition. This single center, open-label, randomized controlled clinical trial selects Nutren® Optimum as oral nutritional support for interventional group while routine diet guidance for control group, aiming to evaluate the efficacy and safety of early and whole course nutritional support by Nutren® Optimum during intensity modulated radiation therapy for nasopharyngeal carcinoma which can improve patients' nutritional state and quality of life, reduce side effects and improve the tolerability and effectiveness of antitumor treatment.
Read the detailed description
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially combined with chemotherapy.
Oral mucositis is just the most common cause of significant weight loss for patients with nasopharyngeal carcinoma during treatment. Patients with oral mucositis will have restriction of normal food, and alternative to semi liquid or liquid diet, resulting in inadequate nutritional intake, malnutrition, weight loss. Furthermore, worse nutrition status will decline immune function, hematopoietic function and repair function, which will influence the patient's quality of life, reduce the tolerance of treatment, and affect treatment effect.
At present, the guidelines at home and abroad more and more emphasize that early nutrition treatment and intervention before systemic malnutrition, also suggest nutrition treatment and intervention at the same time of anti-tumor treatment. Therefore, the timing of nutritional intervention changes from ineffective antitumor therapy as a palliative treatment to the early start of antitumor therapy. For nasopharyngeal carcinoma, early and whole course nutritional intervention can prevent and treat malnutrition or cachexia; improve the treatment tolerance and compliance; control or improve certain adverse reactions of radiotherapy; improve the quality of life; and then improve the function and curative effect. First choice of nutritional intervention is oral nutrition supplement. For patients without gastrointestinal dysfunction, parenteral nutrition is not necessary, even harmful, increasing the risk of infection.
Nutren® Optimum has a higher protein ratio (P:F:C = 17:35:48), and 50% of the protein sources were lactalbumin and 50% casein. Lactalbumin is a high-quality protein, which dissolved and dispersed in the whey protein. Lactalbumin is easy digestion and absorption, with high bioavailability, and net protein utilization rate (NPU) is higher than that of casein and soy protein. Lactalbumin is rich in branched chain amino acids, which can be used as energy material for energy. Lactalbumin has a sulfur-containing amino acid, which can maintain the level of GSH and be in the role of antioxidation; containing glutamine, which contributes to muscle glycogen update and improves immune function. In addition, lactalbumin can also significantly reduce neutrophil apoptosis, enhance neutrophil migration and phagocytosis, and enhance the immune function. Therefore, lactalbumin has the highest nutritional value among a variety of proteins, known as protein king. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin.
Nutren® Optimum contains dietary fiber, which produces short chain fatty acids to promote the proliferation of intestinal probiotics, and play anti-inflammatory, pro-apoptotic, anti-tumor effect, and maintain intestinal health. At the same time, vitamin E is specially added in Nutren® Optimum to protect T lymphocytes, protect red blood cells, anti-oxidation, inhibit platelet aggregation, enhance immunity, and so on. In addition, 64% fat sources of Nutren® Optimum are monounsaturated fat, which conducive to the metabolism of glucose and lipid. Especially added L-carnitine can promote fat oxidation by using better fat for energy, without reducing water and muscle. Nutren® Optimum provides 30 kinds of vitamins and minerals and other nutrients, and can provide a comprehensive and balanced nutrition.
This single center, open-label, randomized controlled clinical trial selects Nutren® Optimum as oral nutritional support for interventional group while routine diet guidance for control group, aiming to evaluate the efficacy and safety of early and whole course nutritional support by Nutren® Optimum during intensity modulated radiation therapy for nasopharyngeal carcinoma, which can improve patients' nutritional state and quality of life, reduce side effects and improve the tolerability and effectiveness of antitumor treatment.
- Conditions
- Nasopharyngeal Carcinoma, Nutritional Support
- Being tested
- Radiotherapy, Chemotherapy, Nutren® Optimum
- Keywords
- nasopharyngeal carcinoma, nutritional support, early and whole course, efficacy and safety
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Intensity Modulated Radiation Therapy, Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
ChemotherapyDrug
Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
Nutren® OptimumDietary supplement
Nutren® Optimum, 7 scoops each time, three times a day, at begin of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The patients in the Experimental Group are allocated to receive radical radiotherapy with or without chemotherapy plus Nutren® Optimum of 7 scoops tid at begin of radiotherapy. Receives: Radiation: Radiotherapy; Drug: Chemotherapy; Dietary Supplement: Nutren® Optimum |
| Controlled Group | Active comparator | The patients in the Controlled Group are allocated to receive radical radiotherapy with or without chemotherapy plus routine diet guidance at begin of radiotherapy. Receives: Radiation: Radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in nutritional status needed upgrading nutritional intervention
The percentage of patients whose body weight decreased by 5% over baseline, or the PG-SGA score was more than 8, or the NRS2002 score was more than 3.
Measured: 3 months after radiotherapy
Secondary outcomes (5)
Quality of life
The standard scores assessed by EORTC QOL scale decreased by more than 10 points
Measured: 3 months after radiotherapy
Moderate and severe bone marrow depression and anemia
Incidence of 3-4 degrees bone marrow depression and anemia according to CTCAE (version 4)
Measured: 3 months after radiotherapy
Severe oral mucositis
Incidence of 3-4 degrees oral mucositis according to CTCAE (version 4)
Measured: 3 months after radiotherapy
Interruption rate of radiotherapy and/or chemotherapy caused by intolerance
The percentage of patients whose radiotherapy and/or chemotherapy were interrupted by treatment-related toxicity intolerance
Measured: 3 months after radiotherapy
Complete remission
The percentage of patients whose all the target lesions disappeared, no new lesions appeared according to RECIST
Measured: 3 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients eligible are divided randomly. All the patients will receive radical radiotherapy with or without chemotherapy. The cases in the Experimental Group will receive Nutren® Optimum of 7 scoops tid at begin of radiotherapy.
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Health Science
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, M.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344068
- Sponsor's protocol ID
- B2017-055-01
- Status last verified
- Nov 2017
- First submitted
- 25 Oct 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Randomized Controlled Clinical Trial on the Early and Whole Course Nutritional Support by Nutren® Optimum During Intensity Modulated Radiation Therapy for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03344068
- Acronym / sponsor ID
- B2017-055-01
- Conditions
- Nasopharyngeal Carcinoma, Nutritional Support
- Keywords
- nasopharyngeal carcinoma, nutritional support, early and whole course, efficacy and safety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Nestle Health Science
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 17 Nov 2017 (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.
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially combined with chemotherapy. Significant weight loss caused by Oral mucositis will keep patients in worse nutrition status and then to decline immune function, hematopoietic function and repair function, which will influence the patient's quality of life, reduce the tolerance of treatment, and affect treatment effect. At present, the guidelines at home and abroad more and more emphasize that early nutrition treatment and intervention before systemic malnutrition, also suggest nutrition treatment and intervention at the same time of anti-tumor treatment. First choice of nutritional intervention is oral nutrition supplement. Nutren® Optimum has a higher protein ratio and 50% of the protein sources were lactalbumin and 50% casein. Lactalbumin is a high-quality protein, with the highest nutritional value among a variety of proteins. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin. Nutren® Optimum also contains dietary fiber, vitamin E, monounsaturated fat, L-carnitine, 30 kinds of vitamins and minerals and other nutrients, which can provide a comprehensive and balanced nutrition. This single center, open-label, randomized controlled clinical trial selects Nutren® Optimum as oral nutritional support for interventional group while routine diet guidance for control group, aiming to evaluate the efficacy and safety of early and whole course nutritional support by Nutren® Optimum during intensity modulated radiation therapy for nasopharyngeal carcinoma which can improve patients' nutritional state and quality of life, reduce side effects and improve the tolerability and effectiveness of antitumor treatment.
Detailed description
Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially combined with chemotherapy.
Oral mucositis is just the most common cause of significant weight loss for patients with nasopharyngeal carcinoma during treatment. Patients with oral mucositis will have restriction of normal food, and alternative to semi liquid or liquid diet, resulting in inadequate nutritional intake, malnutrition, weight loss. Furthermore, worse nutrition status will decline immune function, hematopoietic function and repair function, which will influence the patient's quality of life, reduce the tolerance of treatment, and affect treatment effect.
At present, the guidelines at home and abroad more and more emphasize that early nutrition treatment and intervention before systemic malnutrition, also suggest nutrition treatment and intervention at the same time of anti-tumor treatment. Therefore, the timing of nutritional intervention changes from ineffective antitumor therapy as a palliative treatment to the early start of antitumor therapy. For nasopharyngeal carcinoma, early and whole course nutritional intervention can prevent and treat malnutrition or cachexia; improve the treatment tolerance and compliance; control or improve certain adverse reactions of radiotherapy; improve the quality of life; and then improve the function and curative effect. First choice of nutritional intervention is oral nutrition supplement. For patients without gastrointestinal dysfunction, parenteral nutrition is not necessary, even harmful, increasing the risk of infection.
Nutren® Optimum has a higher protein ratio (P:F:C = 17:35:48), and 50% of the protein sources were lactalbumin and 50% casein. Lactalbumin is a high-quality protein, which dissolved and dispersed in the whey protein. Lactalbumin is easy digestion and absorption, with high bioavailability, and net protein utilization rate (NPU) is higher than that of casein and soy protein. Lactalbumin is rich in branched chain amino acids, which can be used as energy material for energy. Lactalbumin has a sulfur-containing amino acid, which can maintain the level of GSH and be in the role of antioxidation; containing glutamine, which contributes to muscle glycogen update and improves immune function. In addition, lactalbumin can also significantly reduce neutrophil apoptosis, enhance neutrophil migration and phagocytosis, and enhance the immune function. Therefore, lactalbumin has the highest nutritional value among a variety of proteins, known as protein king. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin.
Nutren® Optimum contains dietary fiber, which produces short chain fatty acids to promote the proliferation of intestinal probiotics, and play anti-inflammatory, pro-apoptotic, anti-tumor effect, and maintain intestinal health. At the same time, vitamin E is specially added in Nutren® Optimum to protect T lymphocytes, protect red blood cells, anti-oxidation, inhibit platelet aggregation, enhance immunity, and so on. In addition, 64% fat sources of Nutren® Optimum are monounsaturated fat, which conducive to the metabolism of glucose and lipid. Especially added L-carnitine can promote fat oxidation by using better fat for energy, without reducing water and muscle. Nutren® Optimum provides 30 kinds of vitamins and minerals and other nutrients, and can provide a comprehensive and balanced nutrition.
This single center, open-label, randomized controlled clinical trial selects Nutren® Optimum as oral nutritional support for interventional group while routine diet guidance for control group, aiming to evaluate the efficacy and safety of early and whole course nutritional support by Nutren® Optimum during intensity modulated radiation therapy for nasopharyngeal carcinoma, which can improve patients' nutritional state and quality of life, reduce side effects and improve the tolerability and effectiveness of antitumor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients eligible are divided randomly. All the patients will receive radical radiotherapy with or without chemotherapy. The cases in the Experimental Group will receive Nutren® Optimum of 7 scoops tid at begin of radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Radiation: Radiotherapy, Drug: Chemotherapy, Dietary Supplement: Nutren® OptimumThe patients in the Experimental Group are allocated to receive radical radiotherapy with or without chemotherapy plus Nutren® Optimum of 7 scoops tid at begin of radiotherapy. |
| Controlled Group | Active comparator | Radiation: Radiotherapy, Drug: ChemotherapyThe patients in the Controlled Group are allocated to receive radical radiotherapy with or without chemotherapy plus routine diet guidance at begin of radiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed and previously untreated nasopharyngeal carcinoma without distant metastasis.
- Age ≥ 18 years and < 65 years.
- Karnofsky performance status (KPS) score ≥ 70.
- Planned to receive radiotherapy alone or concurrent chemoradiotherapy, with intensity-modulated radiation therapy (IMRT).
- Adequate normal organ function.
Key exclusion criteria (3 listed)
- Known allergic reaction to any component of Nutren® Optimum, or severe allergic constitution.
- Poor compliance.
- Other conditions that the investigators consider as inappropriate for enrolling into this study.
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 |
|---|---|---|
| RadiotherapyIntensity Modulated Radiation Therapy, Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy. | Radiation | Controlled Group, Experimental Group |
| ChemotherapyNedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles. | Drug | Controlled Group, Experimental Group |
| Nutren® OptimumNutren® Optimum, 7 scoops each time, three times a day, at begin of radiotherapy | Dietary supplement | Experimental Group |
Primary outcome
Decline in nutritional status needed upgrading nutritional intervention
Time frame: 3 months after radiotherapy
The percentage of patients whose body weight decreased by 5% over baseline, or the PG-SGA score was more than 8, or the NRS2002 score was more than 3.
5 secondary outcomes
Quality of life
Time frame: 3 months after radiotherapy
Moderate and severe bone marrow depression and anemia
Time frame: 3 months after radiotherapy
Severe oral mucositis
Time frame: 3 months after radiotherapy
Interruption rate of radiotherapy and/or chemotherapy caused by intolerance
Time frame: 3 months after radiotherapy
Complete remission
Time frame: 3 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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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.
Yun-fei Xia, M.D principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiotherapy, Chemotherapy and Nutren® Optimum in people with Nasopharyngeal Carcinoma and Nutritional Support, 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 8 inclusion and 3 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 22 Dec 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yun-fei Xia, M.D (86-13602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in nutritional status needed upgrading nutritional intervention (time frame: 3 months after radiotherapy). 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 22 Dec 2017; AzTrials last refreshed its copy on 6 Nov 2026.