A Multicenter, Randomized, Double-blind Clinical Trial of TCM in Reducing CRF Caused by Chemotherapy in Cancer Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Fatigue score
Study Overview
Brief Summary
This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.
Detailed Description
In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Malignant tumor patients with pathological diagnosis
- •Men and women aged 18-75
- •KPS score ≥ 70, expected survival time more than 6 months
- •The function of heart, lung, liver and kidney was normal
- •Hemoglobin ≥ 8g
- •Neuroendocrine function is normal
- •BMI ≥ 18.
- •Cancer pain, VAS score < 3
- •Fatigue score ≥ 4
- •syndrome differentiation is deficiency of Qi and blood
Exclusion Criteria
- •Brain metastases with Symptomatic
- •Mental disease
- •Severe infection
- •Insomniacs
- •Pregnant or lactating women
Arms & Interventions
TCM decoction
Compound granules of Traditional Chinese Medicine
Intervention: TCM Formula (Drug)
placebo
Placebo only
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Fatigue score
Time Frame: 21 days
Self-assessed 24-hour fatigue symptom score. According to the NCCN fatigue guide, the score is 0-10 points, 0 points means no fatigue, 10 points means the most serious fatigue that can be imagined.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sun Hong
Director
Peking University Cancer Hospital & Institute