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Trial Title:
Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules
NCT ID:
NCT06381557
Condition:
Cancer-related Fatigue
Conditions: Official terms:
Fatigue
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Zhengyuan Capsules
Description:
Zhengyuan capsules, 4 capsules at a time, 3 times per day;
Arm group label:
Experimental Group
Other name:
A listed Chinese Medicine
Intervention type:
Drug
Intervention name:
Placebo contains 5%-10% Zhengyuan Capsule total mixed powder
Description:
Zhengyuan capsules simulator（Placebo contains 5%-10% Zhengyuan Capsule total mixed
powder）, 4 capsules at a time, 3 times per day;
Arm group label:
Control Group
Other name:
Placebo
Summary:
Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the
symptoms and quality of life of cancer patients, but many research results need to be
further verified by clinical trials with larger samples and better design.This study aims
to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue
in patients with breast cancer.
Detailed description:
By conducting multi-center, randomized, double-blind, placebo-controlled clinical
research to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related
fatigue in patients with breast cancer.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
Cytokines and immunological indicators, 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histopathologically or cytologically confirmed as breast cancer; AJCC 8th edition
staging for breast cancer is stages I to III, clinically and radiologically
confirmed with no tumor recurrence or metastasis.
2. Completed anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeted
therapy) for at least 2 months, with no planned anti-tumor treatment during the
study period, excluding endocrine therapy.
3. Meets the diagnosis criteria for cancer-related fatigue.
4. Average score on the Brief Fatigue Inventory (BFI) in the 14 days preceding
enrollment is ≥4.
5. Life expectancy of at least 6 months.
6. Age between 18 and 70 years old.
7. Patients and their families understand the basic details of the study, agree to
cooperate in completing the relevant research; the patient can communicate verbally
and in writing; voluntary signing of the informed consent form.
Exclusion Criteria:
1. Presence of significant liver or kidney dysfunction (e.g., alanine transaminase,
aspartate transaminase greater than 3 times the upper limit of normal, blood
creatinine greater than 1.5 times the upper limit of normal, eGFR <60
mL/min/1.73m²) or abnormalities in the hematological system (platelet count
<75×10⁹/L, hemoglobin <100g/L, or neutrophil count
<1.5×10⁹/L);
2. Presence of severe primary diseases in the cardiovascular, cerebrovascular, immune
systems, or requiring treatment for mental illness;
3. Hypokalemia (blood potassium <3.0mmol/L) or electrolyte imbalance
with related symptoms or symptoms that may occur after enrollment;
4. Unimproved hypothyroidism;
5. Hypoalbuminemia (blood albumin <30g/L) or malnutrition (Body Mass
Index, BMI <18 kg/m²);
6. Traditional Chinese medicine syndrome pattern consistent with Yin deficiency and
internal heat;
7. Use of medications indicated in the instructions or with main functions that meet
the following conditions: other Western or Chinese medicine preparations that affect
the efficacy evaluation of cancer-related fatigue; undergoing treatment with
anti-anemia, anti-anxiety/depression, anti-insomnia, or other psychostimulant drugs;
use of drugs with leukocyte-increasing effects within the past week, such as
granulocyte colony-stimulating factor (G-CSF);
8. Known allergy to the investigational drug or its components;
9. Breastfeeding, pregnant, or planning to become pregnant within 3 months;
10. The investigator deems the individual unsuitable for participation in this clinical
trial.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Qiang Fu
Agency class:
Other
Collaborator:
Agency:
Yangtze River Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06381557
