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

March 11, 2017 updated by: Zhiyong Wu, Chinese PLA General Hospital

Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 1000853
        • PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GLSE compound group
GLSE compound 2g each time by mouth,twice a day for 42 days.
Drug: GLSE compound
EXPERIMENTAL: Maitake mushroom extract compound group
Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.
Drug: Maitake mushroom extract compound
EXPERIMENTAL: Ginseng compound group
Ginseng compound 2 tables each time by mouth,twice a day for 42 days.
Drug: Ginseng compound
NO_INTERVENTION: blank control group
Take nothing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-lymphocyte cell subsets
Time Frame: three mouths
T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level
three mouths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Shunchang Jiao, Doctor, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (ESTIMATE)

November 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 11, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGHS201503601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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