NCT02771756

Brief Summary

The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy.

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
300

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable breast-cancer

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

Study Start

First participant enrolled

May 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

April 18, 2016

Last Update Submit

May 12, 2016

Conditions

Breast CancerLung Cancer

Keywords

Breast cancerLung cancerNutritional supportSafetyEffectiveness

Outcome Measures

Primary Outcomes (5)

  • Weight change rate

    6 weeks and 9 weeks after baseline.

  • Siderophilin change status

    6 weeks and 9 weeks after baseline.

  • Interleukin 1 change status

    6 weeks and 9 weeks after baseline.

  • interleukin 6 change status

    6 weeks and 9 weeks after baseline.

  • Tumor Necrosis Factor α change status

    6 weeks and 9 weeks after baseline.

Secondary Outcomes (13)

  • Change status of the Gripping Power

    6 weeks and 9 weeks after baseline.

  • Prealbumin Blood Examination change status

    6 weeks and 9 weeks after baseline.

  • Albumin change status

    6 weeks and 9 weeks after baseline.

  • Total Bilirubin change status

    6 weeks and 9 weeks after baseline.

  • Bilirubin Direct change status

    6 weeks and 9 weeks after baseline.

  • +8 more secondary outcomes

Other Outcomes (2)

  • Quality of life questionnaire(QOL-C30)

    At baseline,6 weeks and 9 weeks after baseline.

  • Scored Patient-Generated Subjective Global Assessment(PG-SGA)

    At baseline

Study Arms (2)

test group

EXPERIMENTAL

Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously.

Dietary Supplement: zhen qishen capsule and Oral Supplement of YuyikangRadiation: chemotherapyOther: nutrition education

placebo group

PLACEBO COMPARATOR

Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g,Bid), a total of 150 people, are used for 42 days continuously.

Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placeboRadiation: chemotherapyOther: nutrition education

Interventions

zhen qishen capsule and Oral Supplement of YuyikangDIETARY_SUPPLEMENT
test group
zhen qishen capsule placebo and Oral Supplement of Yuyikang placeboDIETARY_SUPPLEMENT
placebo group
chemotherapyRADIATION
placebo grouptest group
nutrition educationOTHER
placebo grouptest group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 70 years old
  • Breast or lung cancer was diagnosed by pathology or cytology
  • ECOG score: 0-2 points
  • PG-SGA: 2-8 points, while the weight loss within 3 months less than 5%
  • The organ function is good, with chemotherapy index. ANC is equal to or over 1.5 \* 10\^9/L, PLT is equal to or over 100\* 10\^9/L, HGB is equal to or over 90g/L
  • Bilirubin is equal to or less than 1.5 times of the normal upper limit, AP, AST, ALT is less than or equal to 2 times of normal upper limit
  • Ccr is equal to or over 50mL/min
  • Life expectancy is equal to or over 12 weeks

You may not qualify if:

  • Complete or incomplete intestinal obstruction
  • A severe infection or difficult to control diabetes
  • History of organ transplantation, or current use of immunosuppressive agents
  • An intervention in nutritional supplements, or a metabolic disorder
  • Parenteral nutrition must be applied
  • Alcoholism or drug addiction
  • Pregnancy or lactation, or women of childbearing age refuse contraception
  • There are potential factors that interfere with the mental, psychological, family, social or geographical and other factors of the research project
  • There are other diseases that may interfere with the results of this study, such as the second primary tumor
  • For any other reason, the researchers were unable to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLung Neoplasms

Interventions

Drug TherapyNutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Peng Yuan, MD

    Chief physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, MD

CONTACT

00861087788528Yuanpeng01@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 18, 2016

First Posted

May 13, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)