Fufang E'Jiao Jiang Intervening Cancer-related Fatigue

Last updated: February 21, 2020
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04147312
2018YFC1707406
  • Ages 18-75
  • All Genders

Study Summary

With the therapeutic tool of carcinoma increasing, life span extending, the solicitude for the patients'quality of life appear more important. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Our previous clinical experience have shown that traditional Chinese medicine（TCM） had a great effect on improving CRF, Several studies proven that its'mechanism were related to the regulation of immune function and endocrine hormones. Fufang E'Jiao Jiang (FFEJJICRF) is a commonly-used Chinese patent medicine and successfully marketed in China for many years, which are effective in improvement for TCM symptoms of deficiency with qi and blood. This proposal will investigate the effects of FFEJJICRF on CRF among non-small cell lung cancer, colorectal cancer, and gastric cancer, so as to find a new way for curing it in clinical.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The age of patients between 18 and 75，gender not limited.

  2. Patients that pathologically diagnosed with colorectal cancer, non-small cell lungcancer (NSCLC) or gastric cancer.

  3. The patients' TNM stage of NSCLC is IIIB-IV, colorectal cancer is IV, and gastriccancer is IV, in addition all of them should be with tumors that can not be radicallyresected.

  4. If patients have not received chemotherapy, they should be evaluated that tumor willnot progress within 30 days, and their bodies can tolerate intravenous targetedtherapy.

  5. Patients who meet the diagnostic criterion for cancer related fatigue with deficiencyof qi and blood.

  6. The expected survival period is more than 3 months.

  7. Fatigue score evaluated by visual analogue fatigue scale isn't lower than 4, andKarnofsky scale score isn't lower than 60.

  8. Good compliance and agreeable to sign an informed consent before test.

  9. Subjects agree not to participate in other intervention studies during test.

Exclusion

Exclusion Criteria:

  1. Those who need immunotherapy or radiotherapy during the test.

  2. Those who have significant trauma injuries in the past one month.

  3. Those who have severe bleeding or systemic infection diseases that had not beencompletely controlled.

  4. Those who have tangible proofs of marrow or central nervous system metastasis.

  5. Those who have received erythropoietin or blood transfusion within 1 month beforetest.

  6. Those who have hypersplenism, hyperthyroidism, desmosis, tuberculosis and otherdiseases that have not been completely controlled.

  7. Those who complicated with serious diseases such as cardiovascular or cerebrovascularsystem diseases, active hepatitis, disfunction of liver or kidney.

  8. Those who are known or suspected to be allergic to test drugs.

  9. Those who have eaten EJiao products in the past 2 weeks.

  10. Those who have occurred Ileus.

  11. Those suffering from severe malabsorption or other diseases that affectgastrointestinal absorption.

  12. Those who cannot understand, read and fill in the self-rating scale due to their levelof knowledge or intelligence.

  13. Those who may happen any unstable conditions or conditions that endanger the patient'ssafety or compliance, for example the spirits.

  14. Those who have been diagnosed with other malignant tumors (except fully treated cervixand skin carcinoma in situ, or other tumors that have been surgically cured and notrecurred for at least 5 years) .

  15. Those who participated in other therapeutic clinical trials within 30 days.

  16. Pregnant or nursing women, or childbearing female that are inadequate contraception.

  17. Those who are inappropriate to participate in the study determined by investigators.

Study Design

Total Participants: 600
Study Start date:
October 17, 2019
Estimated Completion Date:
December 31, 2021

Study Description

By conducting large sample, multicenter, double-blind, randomized comparison clinical research, this test will investigate the effects of fufang E'Jiao Jiang intervening cancer-related fatigue (CRF) with deficiency of qi and blood, under the guidance of its specification. This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators. And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of hormone, immune and metabonomics, so as to explore the advantages of traditional Chinese medicine（TCM） in the treatment of CRF and support some high quality, internationally recognized clinical evidence.

Connect with a study center

  • Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing 100091
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.