MalnutritionNSTBIPAGCNCT03631537
Nutrition-support-team Based Intervention in Patients With Advanced Gastrointestinal Cancer
A study testing NST group in people with Malnutrition and Gastrointestinal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malnutrition, Gastrointestinal Cancer, Nutrition Aspect of Cancer
- What is being tested?
- NST group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2018to 31 Dec 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced (recurrent or metastatic) gastrointestinal malignancies confirmed by pathology, plan to be treated with chemotherapy
- the expected life period is more than 3 months
- did not receive chemotherapy, radiotherapy, molecular targeted therapy or surgery in the last 4 weeks
- has been recovered from the acute toxicity of previous treatment (if patient received surgery, the wound must have completely healed)
- at least one measurable lesion according to RECIST 1.1 edition (the measurable lesion has not received radiotherapy)
- normal function of main organs:Blood routine examination needs to be met: Hb≥90g/L (without blood transfusions within 14 days); ANC≥1.5×109/L; PLT≥80×109/LBiochemical examination should conform to the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN (ALT and AST≤5×ULN, in case of liver metastasis); Serum creatinine ≤1×ULN, creatinine clearance rate >50ml/min (Cockcroft-Gault formula)
- volunteer to participate in the study, sign the informed consent, and cooperate with good compliance
Who cannot join
- pregnancy or lactation
- having a long-term unhealed wound, traumatic or pathological fracture
- urinary protein > 2+ or 24 hour urinary protein >1.0g
- suffering from mental illness
- with hypertension and fail to get good control through antihypertensive medication (systolic pressure >140mmHg and/or diastolic pressure >90mmHg)
- serious diabetes, heart disease (including but not limited to myocardial ischemia, myocardial infarction, cardiac insufficiency, congestive heart failure), thrombotic diseases (including but not limited to cerebral hemorrhage, deep venous thrombosis and pulmonary embolism)
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- long-term use of steroid for other medical reasons
- with diseases that may increasing the underlying research risk judged by researchers
- having a bleeding tendency or a great worry of gastrointestinal bleeding
- with infection requiring antibiotic treatment
- history of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders
- patients with Hepatitis B(except inactive carrier) or Hepatitis C
- took part in other clinical studies or is involved in other research projects at present
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Lingxiao Zhang, doctor, +8618066910386, 514324869@qq.com
About this study
Official title: Effect of Nutrition-support-team Based Intervention on Nutritional Status, Chemotherapy Tolerance and Prognosis in Patients With Advanced Gastrointestinal Cancer
The research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. All patients receive the nutritional risk assessment by the nutritional support team first, and patients with nutritional risk or malnutrition are randomly assigned to the study group and the control group. The study group receive nutritional intervention from the nutritional support team during the period of chemotherapy, while the control group receive routine nutritional support from their clinicians. In the control group, nurses execute the doctors' advice on nutrition, and the nutrition support team does not actively communicate with doctors about the nutritional risk of patients or interfere with it. The baseline characteristics, chemotherapy efficacy, adverse events and prognosis are collected in both groups. At last, data are analyzed to clarify the nutritional status and related factors of patients with advanced gastrointestinal cancer in our hospital, and most important to explore the effect of nutrition-support-team intervention on nutritional status, chemotherapy tolerance and prognosis of patients with advanced gastrointestinal cancer.
Read the detailed description
Baseline data include age, gender, pain, sleep condition, family care, tumor type, tumor stage, combined disease, chemotherapy regimen and concomitant medication.
Nutritional risk assessments are performed by the nutrition support team just after enrollment, every two cycles of chemotherapy and at the end of the study. The adverse events of chemotherapy are collected and recorded at the end of each cycle. CT or MRI is performed to evaluate efficacy of chemotherapy every two treatment cycles. Patient after one treatment cycle can receive CT or MRI in advance if the clinical condition is worsening.
- Being tested
- NST group
- Medical subject headings
- Malnutrition, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NST groupOther
Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education
| Study group | Role | What they receive |
|---|---|---|
| NST group | Experimental | Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy Receives: Other: NST group |
| routine group | No intervention | clinicians decide whether to give and how to give the dietary supplement and other nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional status
effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments
Measured: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
Secondary outcomes (4)
chemo-related adverse events
amount of chemo-related adverse events
Measured: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
total chemotherapy cycles
amount of total cycles of chemotherapy
Measured: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
progression-free survival
the survival time of patient without progression
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
adverse events
Amount of adverse events related to nutritional intervention
Measured: From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start20 Aug 2018 (estimated)
- Primary completion20 Aug 2020 (estimated)
- Study completion31 Dec 2020 (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.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study group: receive nutritional intervention from the nutritional support team; Control group: receive routine nutritional support from clinicians
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingxiao Zhang, doctor, Study director, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631537
- Sponsor's protocol ID
- XJTU1AF-CRF-2017-027
- Acronym
- NSTBIPAGC
- Status last verified
- Nov 2017
- First submitted
- 13 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition-support-team Based Intervention on Nutritional Status, Chemotherapy Tolerance and Prognosis in Patients With Advanced Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT03631537
- Acronym / sponsor ID
- NSTBIPAGC / XJTU1AF-CRF-2017-027
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (estimated)
- Primary completion
- 20 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Aug 2018 (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 research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. All patients receive the nutritional risk assessment by the nutritional support team first, and patients with nutritional risk or malnutrition are randomly assigned to the study group and the control group. The study group receive nutritional intervention from the nutritional support team during the period of chemotherapy, while the control group receive routine nutritional support from their clinicians. In the control group, nurses execute the doctors' advice on nutrition, and the nutrition support team does not actively communicate with doctors about the nutritional risk of patients or interfere with it. The baseline characteristics, chemotherapy efficacy, adverse events and prognosis are collected in both groups. At last, data are analyzed to clarify the nutritional status and related factors of patients with advanced gastrointestinal cancer in our hospital, and most important to explore the effect of nutrition-support-team intervention on nutritional status, chemotherapy tolerance and prognosis of patients with advanced gastrointestinal cancer.
Detailed description
Baseline data include age, gender, pain, sleep condition, family care, tumor type, tumor stage, combined disease, chemotherapy regimen and concomitant medication.
Nutritional risk assessments are performed by the nutrition support team just after enrollment, every two cycles of chemotherapy and at the end of the study. The adverse events of chemotherapy are collected and recorded at the end of each cycle. CT or MRI is performed to evaluate efficacy of chemotherapy every two treatment cycles. Patient after one treatment cycle can receive CT or MRI in advance if the clinical condition is worsening.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study group: receive nutritional intervention from the nutritional support team; Control group: receive routine nutritional support from clinicians
| Arm | Type | Receives |
|---|---|---|
| NST group | Experimental | Other: NST groupNutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy |
| routine group | No intervention | –clinicians decide whether to give and how to give the dietary supplement and other nutritional support |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- advanced (recurrent or metastatic) gastrointestinal malignancies confirmed by pathology, plan to be treated with chemotherapy
- the expected life period is more than 3 months
- did not receive chemotherapy, radiotherapy, molecular targeted therapy or surgery in the last 4 weeks
- has been recovered from the acute toxicity of previous treatment (if patient received surgery, the wound must have completely healed)
- at least one measurable lesion according to RECIST 1.1 edition (the measurable lesion has not received radiotherapy)
Key exclusion criteria (13 listed)
- pregnancy or lactation
- having a long-term unhealed wound, traumatic or pathological fracture
- urinary protein > 2+ or 24 hour urinary protein >1.0g
- suffering from mental illness
- with hypertension and fail to get good control through antihypertensive medication (systolic pressure >140mmHg and/or diastolic pressure >90mmHg)
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 |
|---|---|---|
| NST groupNutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education | Other | NST group |
Primary outcome
nutritional status
Time frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments
4 secondary outcomes
chemo-related adverse events
Time frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
total chemotherapy cycles
Time frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months
progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
adverse events
Time frame: From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
Lingxiao Zhang, doctor study director
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NST group in people with Malnutrition and Gastrointestinal Cancer, run by First Affiliated Hospital Xi'an Jiaotong 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 7 inclusion and 13 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 21 Aug 2018. 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 Lingxiao Zhang, doctor (+8618066910386, 514324869@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional status (time frame: From time of randomization to the date of chemotherapy ends or date of death from any cause, whichever came first, assessed up to 6 months). 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 21 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.