Tumor, SolidNCT06730204
Standardized Nutritional Management of Pediatric Patients With Solid Tumors
A study testing Standardized nutritional management and Standardized nutritional management + short peptide ONS in people with Tumor, Solid and Children, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tumor, Solid, Children, Nutritional Intervention
- What is being tested?
- Standardized nutritional management and Standardized nutritional management + short peptide ONS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
- Male and female, age 0-18 years old
- Pathological diagnosis is malignant solid tumor with untreated initial onset
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Tian Qian, PhD, 021-64931913, drqiantian@fudan.edu.cn
About this study
Official title: Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study
The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.
After admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.
- Conditions
- Tumor, Solid, Children, Nutritional Intervention
- Being tested
- Standardized nutritional management, Standardized nutritional management + short peptide ONS
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized nutritional managementDietary supplement
The children will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.
Standardized nutritional management + short peptide ONSDietary supplement
During the study period, an additional 3 months of short peptide ONS enteral nutrition intervention is expected to be performed in children enrolled from Dec 1, 2024 to Feb 28, 2025 to explore the improvement of the nutritional status of the children. Short peptide type ONS 30ml/(kg.d) will be taken orally for children under 3 years old, and 20ml/(kg.d) for children over 3 years old. Due to conditional restrictions, standardized nutritional management + short peptide ONS intervention is only carried out in this subgroup.
Inclusion criteria for short peptide ONS enteral nutrition intervention:
- Male and female, age 1-10 years old
- Pathological diagnosis is malignant solid tumor with untreated initial onset
- It is expected to receive enteral nutrition intervention for 3 months
- Clear consciousness, willing to cooperate, no serious dysfunction of major organ functions
| Study group | Role | What they receive |
|---|---|---|
| Standardized nutrition management（+ short peptide ONS) Group | Experimental | The children in this group will be given standardized nutrition management after admission. They will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.
During the study period, an additional 3 months of short peptide oral nutritional supplements (ONS) is expected to be performed in children enrolled from December 1, 2024 to February 28, 2025 to explore the improvement of the nutritional status of the children. Receives: Dietary Supplement: Standardized nutritional management; Dietary Supplement: Standardized nutritional management + short peptide ONS |
| Control group | No intervention | Clinical variables, biochemical markers, dietary data, and physical activity data will be collected at baseline and at each visit (admission to hospital, 1, 2, 3, 6, 12, 18, and 24 months after diagnosis). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight for age Z score
Weight for age Z score = (Actual weight - reference population median) / reference population standard deviation
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
height/length for age Z score
Height/length for age Z score = (Actual height/length - reference population median) / reference population standard deviation
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
BMI for age Z score
BMI for age Z score = (Actual BMI - reference population median) / reference population standard deviation
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Secondary outcomes (5)
dietary intake
Unit: kcal/d A 24-hour dietary survey record will be conducted on the children to evaluate the quantity, type and energy of the food consumed.
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
serum albumin
Unit: g/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
serum prealbumin
Unit: mg/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
hemoglobin
Unit: g/L This indicator is measured by the hemocytometer XS800I in the hospital laboratory department.
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
electrolytes
Unit: mmol/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
Measured: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730204
- Sponsor's protocol ID
- (2023)136
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olveira G, Tapia MJ, Ocon J, Cabrejas-Gomez C, Ballesteros-Pomar MD, Vidal-Casariego A, Arraiza-Irigoyen C, Olivares J, Conde-Garcia MC, Garcia-Manzanares A, Botella-Romero F, Quilez-Toboso RP, Matia P, Rubio MA, Chicharro L, Burgos R, Pujante P, Ferrer M, Zugasti A, Petrina E, Manjon L, Dieguez M, Carrera MJ, Vila-Bundo A, Urgeles JR, Aragon-Valera C, Sanchez-Vilar O, Breton I, Garcia-Peris P, Munoz-Garach A, Marquez E, Del Olmo D, Pereira JL, Tous MC. Hypoglycemia in noncritically ill patients receiving total parenteral nutrition: a multicenter study. (Study group on the problem of hyperglycemia in parenteral nutrition; Nutrition area of the Spanish Society of Endocrinology and Nutrition). Nutrition. 2015 Jan;31(1):58-63. doi: 10.1016/j.nut.2014.04.023. Epub 2014 May 10.
PubMed 25441588White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). JPEN J Parenter Enteral Nutr. 2012 May;36(3):275-83. doi: 10.1177/0148607112440285.
PubMed 22535923Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.
PubMed 19682776Mohamed Elfadil O, Steien DB, Narasimhan R, Velapati SR, Epp L, Patel I, Patel J, Hurt RT, Mundi MS. Transition to peptide-based diet improved enteral nutrition tolerance and decreased healthcare utilization in pediatric home enteral nutrition. JPEN J Parenter Enteral Nutr. 2022 Mar;46(3):626-634. doi: 10.1002/jpen.2202. Epub 2021 Jul 19.
PubMed 34145597Leonard M, Caldari D, Mas E, Lambe C, Comte A, Ley D, Peretti N, Borderon C, Marinier E, Coste ME, Lamireau T, Rubio A, Turquet A, Dubern B, Dabadie A, Gautry J, Kyheng M, Guimber D, Gottrand F. Experience of Using a Semielemental Formula for Home Enteral Nutrition in Children: A Multicenter Cross-sectional Study. J Pediatr Gastroenterol Nutr. 2019 Apr;68(4):585-590. doi: 10.1097/MPG.0000000000002236.
PubMed 30896609Brinksma A, Sanderman R, Roodbol PF, Sulkers E, Burgerhof JG, de Bont ES, Tissing WJ. Malnutrition is associated with worse health-related quality of life in children with cancer. Support Care Cancer. 2015 Oct;23(10):3043-52. doi: 10.1007/s00520-015-2674-0. Epub 2015 Mar 10.
PubMed 25752883Becker P, Carney LN, Corkins MR, Monczka J, Smith E, Smith SE, Spear BA, White JV; Academy of Nutrition and Dietetics; American Society for Parenteral and Enteral Nutrition. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). Nutr Clin Pract. 2015 Feb;30(1):147-61. doi: 10.1177/0884533614557642. Epub 2014 Nov 24.
PubMed 25422273Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
PubMed 27637832Sasse P, Bergmann A, Afonso W, Ladas EJ, Ferman S. Malnutrition at diagnosis and throughout therapy in pediatric patients with solid tumors: A single-institution study in a developing country. Pediatr Blood Cancer. 2021 Nov;68(11):e29317. doi: 10.1002/pbc.29317. Epub 2021 Sep 7.
PubMed 34490992Runco DV, Stanek JR, Yeager ND, Belsky JA. Malnutrition identification and management variability: An administrative database study of children with solid tumors. JPEN J Parenter Enteral Nutr. 2022 Sep;46(7):1559-1567. doi: 10.1002/jpen.2329. Epub 2022 Feb 10.
PubMed 35040171Viana ECRM, Oliveira IDS, Rechinelli AB, Marques IL, Souza VF, Spexoto MCB, Pereira TSS, Guandalini VR. Malnutrition and nutrition impact symptoms (NIS) in surgical patients with cancer. PLoS One. 2020 Dec 15;15(12):e0241305. doi: 10.1371/journal.pone.0241305. eCollection 2020.
PubMed 33320857Bullock AF, Greenley SL, McKenzie GAG, Paton LW, Johnson MJ. Relationship between markers of malnutrition and clinical outcomes in older adults with cancer: systematic review, narrative synthesis and meta-analysis. Eur J Clin Nutr. 2020 Nov;74(11):1519-1535. doi: 10.1038/s41430-020-0629-0. Epub 2020 May 4.
PubMed 32366995Schoeman J. Nutritional assessment and intervention in a pediatric oncology unit. Indian J Cancer. 2015 Apr-Jun;52(2):186-90. doi: 10.4103/0019-509X.175832.
PubMed 26853397
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study
- ClinicalTrials.gov ID
- NCT06730204
- Acronym / sponsor ID
- (2023)136
- Conditions
- Tumor, Solid, Children, Nutritional Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2024 (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.
The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.
After admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized nutrition management（+ short peptide ONS) Group | Experimental | Dietary Supplement: Standardized nutritional management, Dietary Supplement: Standardized nutritional management + short peptide ONSThe children in this group will be given standardized nutrition management after admission. They will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected. During the study period, an additional 3 months of short peptide oral nutritional supplements (ONS) is expected to be performed in children enrolled from December 1, 2024 to February 28, 2025 to explore the improvement of the nutritional status of the children. |
| Control group | No intervention | –Clinical variables, biochemical markers, dietary data, and physical activity data will be collected at baseline and at each visit (admission to hospital, 1, 2, 3, 6, 12, 18, and 24 months after diagnosis). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Standardized nutritional managementThe children will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected. | Dietary supplement | Standardized nutrition management（+ short peptide ONS) Group |
| Standardized nutritional management + short peptide ONSDuring the study period, an additional 3 months of short peptide ONS enteral nutrition intervention is expected to be performed in children enrolled from Dec 1, 2024 to Feb 28, 2025 to explore the improvement of the nutritional status of the children. Short peptide type ONS 30ml/(kg.d) will be taken orally for children under 3 years old, and 20ml/(kg.d) for children over 3 years old. Due to conditional restrictions, standardized nutritional management + short peptide ONS intervention is only carried out in this subgroup. Inclusion criteria for short peptide ONS enteral nutrition intervention: 1. Male and female, age 1-10 years old 2. Pathological diagnosis is malignant solid tumor with untreated initial onset 3. It is expected to receive enteral nutrition intervention for 3 months 4. Clear consciousness, willing to cooperate, no serious dysfunction of major organ functions | Dietary supplement | Standardized nutrition management（+ short peptide ONS) Group |
Primary outcome
Weight for age Z score
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Weight for age Z score = (Actual weight - reference population median) / reference population standard deviation
height/length for age Z score
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Height/length for age Z score = (Actual height/length - reference population median) / reference population standard deviation
BMI for age Z score
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
BMI for age Z score = (Actual BMI - reference population median) / reference population standard deviation
5 secondary outcomes
dietary intake
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
serum albumin
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
serum prealbumin
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
hemoglobin
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
electrolytes
Time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 25441588Olveira G, Tapia MJ, Ocon J, Cabrejas-Gomez C, Ballesteros-Pomar MD, Vidal-Casariego A, Arraiza-Irigoyen C, Olivares J, Conde-Garcia MC, Garcia-Manzanares A, Botella-Romero F, Quilez-Toboso RP, Matia P, Rubio MA, Chicharro L, Burgos R, Pujante P, Ferrer M, Zugasti A, Petrina E, Manjon L, Dieguez M, Carrera MJ, Vila-Bundo A, Urgeles JR, Aragon-Valera C, Sanchez-Vilar O, Breton I, Garcia-Peris P, Munoz-Garach A, Marquez E, Del Olmo D, Pereira JL, Tous MC. Hypoglycemia in noncritically ill patients receiving total parenteral nutrition: a multicenter study. (Study group on the problem of hyperglycemia in parenteral nutrition; Nutrition area of the Spanish Society of Endocrinology and Nutrition). Nutrition. 2015 Jan;31(1):58-63. doi: 10.1016/j.nut.2014.04.023. Epub 2014 May 10.
- Results publication: PubMed 22535923White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). JPEN J Parenter Enteral Nutr. 2012 May;36(3):275-83. doi: 10.1177/0148607112440285.
- Results publication: PubMed 19682776Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.
- Results publication: PubMed 34145597Mohamed Elfadil O, Steien DB, Narasimhan R, Velapati SR, Epp L, Patel I, Patel J, Hurt RT, Mundi MS. Transition to peptide-based diet improved enteral nutrition tolerance and decreased healthcare utilization in pediatric home enteral nutrition. JPEN J Parenter Enteral Nutr. 2022 Mar;46(3):626-634. doi: 10.1002/jpen.2202. Epub 2021 Jul 19.
- Results publication: PubMed 30896609Leonard M, Caldari D, Mas E, Lambe C, Comte A, Ley D, Peretti N, Borderon C, Marinier E, Coste ME, Lamireau T, Rubio A, Turquet A, Dubern B, Dabadie A, Gautry J, Kyheng M, Guimber D, Gottrand F. Experience of Using a Semielemental Formula for Home Enteral Nutrition in Children: A Multicenter Cross-sectional Study. J Pediatr Gastroenterol Nutr. 2019 Apr;68(4):585-590. doi: 10.1097/MPG.0000000000002236.
- Results publication: PubMed 25752883Brinksma A, Sanderman R, Roodbol PF, Sulkers E, Burgerhof JG, de Bont ES, Tissing WJ. Malnutrition is associated with worse health-related quality of life in children with cancer. Support Care Cancer. 2015 Oct;23(10):3043-52. doi: 10.1007/s00520-015-2674-0. Epub 2015 Mar 10.
- Results publication: PubMed 25422273Becker P, Carney LN, Corkins MR, Monczka J, Smith E, Smith SE, Spear BA, White JV; Academy of Nutrition and Dietetics; American Society for Parenteral and Enteral Nutrition. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). Nutr Clin Pract. 2015 Feb;30(1):147-61. doi: 10.1177/0884533614557642. Epub 2014 Nov 24.
- Results publication: PubMed 27637832Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.
- Results publication: PubMed 34490992Sasse P, Bergmann A, Afonso W, Ladas EJ, Ferman S. Malnutrition at diagnosis and throughout therapy in pediatric patients with solid tumors: A single-institution study in a developing country. Pediatr Blood Cancer. 2021 Nov;68(11):e29317. doi: 10.1002/pbc.29317. Epub 2021 Sep 7.
- Results publication: PubMed 35040171Runco DV, Stanek JR, Yeager ND, Belsky JA. Malnutrition identification and management variability: An administrative database study of children with solid tumors. JPEN J Parenter Enteral Nutr. 2022 Sep;46(7):1559-1567. doi: 10.1002/jpen.2329. Epub 2022 Feb 10.
- Results publication: PubMed 33320857Viana ECRM, Oliveira IDS, Rechinelli AB, Marques IL, Souza VF, Spexoto MCB, Pereira TSS, Guandalini VR. Malnutrition and nutrition impact symptoms (NIS) in surgical patients with cancer. PLoS One. 2020 Dec 15;15(12):e0241305. doi: 10.1371/journal.pone.0241305. eCollection 2020.
- Results publication: PubMed 32366995Bullock AF, Greenley SL, McKenzie GAG, Paton LW, Johnson MJ. Relationship between markers of malnutrition and clinical outcomes in older adults with cancer: systematic review, narrative synthesis and meta-analysis. Eur J Clin Nutr. 2020 Nov;74(11):1519-1535. doi: 10.1038/s41430-020-0629-0. Epub 2020 May 4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized nutritional management and Standardized nutritional management + short peptide ONS in people with Tumor, Solid and Children, run by Children's Hospital of Fudan 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?
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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Qian, PhD (021-64931913, drqiantian@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight for age Z score (time frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment). The study lists 3 primary outcomes in all. 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 NCT06730204, which also lists 13 linked publications.
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 16 Mar 2026.