NCT03631537

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 21, 2018

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

August 13, 2018

Last Update Submit

August 19, 2018

Conditions

MalnutritionGastrointestinal CancerNutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (1)

  • nutritional status

    effect of nutrition-support-team intervention on nutritional status, nutritional risk assessments

    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

    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

    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

    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

    From time of randomization to one week of the ends of nutritional intervention，assessed up to 7 months

Study Arms (2)

NST group

EXPERIMENTAL

Nutrition support team gives the dietary supplement or other nutritional support during the period of chemotherapy

Other: NST group

routine group

NO INTERVENTION

clinicians decide whether to give and how to give the dietary supplement and other nutritional support

Interventions

NST groupOTHER

Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education

NST group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

MalnutritionGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Lingxiao Zhang, doctor

    First Affiliated Hospital of Xian Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

Lingxiao Zhang, doctor

CONTACT

+8618066910386514324869@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Study group: receive nutritional intervention from the nutritional support team; Control group: receive routine nutritional support from clinicians
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

August 20, 2018

Primary Completion

August 20, 2020

Study Completion

December 31, 2020

Last Updated

August 21, 2018

Record last verified: 2017-11

Locations

CN(1)