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Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

Primary Purpose

Lung Neoplasms, Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GLSE compound
Maitake mushroom extract compound
Ginseng compound
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Neoplasms focused on measuring Clinical Nutrition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lung cancer and breast cancer patients confirmed by surgery pathology;
  • ECOG physical stamina score of 0~3 points;
  • Expected lifetime > 3 months;
  • Need to receive radiation and chemotherapy;
  • Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
  • To follow-up, good adherence

Exclusion Criteria:

  • Allergic to text drug;
  • Pregnancy or lactation women;
  • Suffering from mental illness of not easy to control,
  • Have serious mental or cognitive dysfunction;
  • Can not comply with the experimental scheme or can't cooperate with the follow-up;
  • The patients who are unfavorable to the subject.

Sites / Locations

  • PLA general hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

GLSE compound group

Maitake mushroom extract compound group

Ginseng compound group

blank control group

Arm Description

GLSE compound 2g each time by mouth,twice a day for 42 days.

Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.

Ginseng compound 2 tables each time by mouth,twice a day for 42 days.

Take nothing.

Outcomes

Primary Outcome Measures

T-lymphocyte cell subsets
T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level

Secondary Outcome Measures

Full Information

First Posted
November 10, 2015
Last Updated
March 11, 2017
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02603016
Brief Title
Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Official Title
Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Detailed Description
GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Breast Neoplasms
Keywords
Clinical Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLSE compound group
Arm Type
Experimental
Arm Description
GLSE compound 2g each time by mouth,twice a day for 42 days.
Arm Title
Maitake mushroom extract compound group
Arm Type
Experimental
Arm Description
Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.
Arm Title
Ginseng compound group
Arm Type
Experimental
Arm Description
Ginseng compound 2 tables each time by mouth,twice a day for 42 days.
Arm Title
blank control group
Arm Type
No Intervention
Arm Description
Take nothing.
Intervention Type
Drug
Intervention Name(s)
GLSE compound
Intervention Type
Drug
Intervention Name(s)
Maitake mushroom extract compound
Intervention Type
Drug
Intervention Name(s)
Ginseng compound
Primary Outcome Measure Information:
Title
T-lymphocyte cell subsets
Description
T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level
Time Frame
three mouths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lung cancer and breast cancer patients confirmed by surgery pathology; ECOG physical stamina score of 0~3 points; Expected lifetime > 3 months; Need to receive radiation and chemotherapy; Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L; To follow-up, good adherence Exclusion Criteria: Allergic to text drug; Pregnancy or lactation women; Suffering from mental illness of not easy to control, Have serious mental or cognitive dysfunction; Can not comply with the experimental scheme or can't cooperate with the follow-up; The patients who are unfavorable to the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shunchang Jiao, Doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
PLA general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
1000853
Country
China

12. IPD Sharing Statement

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Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

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