NCT04147312

Fufang E'Jiao Jiang Intervening Cancer-related Fatigue

The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer-related Fatigue

Interventions

Type	Name	Description
DRUG	Fufang E'Jiao Jiang	Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
DRUG	placebo containing low-dose fufang E'Jiao Jiang	placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles

Timeline

• Start date: 2019-10-17
• Primary completion: 2021-05-31
• Completion: 2021-12-31
• First posted: 2019-11-01
• Last updated: 2020-02-25

Locations

1 site across 1 country: China