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A prospective, multicenter, real world study of Yangzheng Xiaoji capsule in the treatment of cancer-related fatigue

A prospective, multicenter, real world study of Yangzheng Xiaoji capsule in the treatment of cancer-related fatigue

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004751
Enrollment
Unknown
Registered
2021-04-18
Start date
2021-05-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant solid tumor

Interventions

Sponsors

Department of Radiotherapy, the Second Affiliated Hospital, Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed as malignant tumor (solid tumor) by pathology or cytology; 2.Patients with moderate to severe fatigue (4-10 points); 3.Clear mind, can objectively cooperate with the doctor to complete the examination and evaluation; 4.ECoG score of physical condition was 0-3; 5.Expected survival >= 3 months; 6.Aged 18-75 years; 7.Voluntary participation, signing informed consent, good compliance and cooperation with follow-up.

Exclusion criteria

Exclusion criteria: 1.Patients with clinically significant liver dysfunction, i.e. glutamic oxaloacetic transaminase or alanine transaminase > 2.5 fold ULN, total serum bilirubin > 1.5 fold ULN; 2.Patients with clinically significant renal insufficiency, i.e. serum creatinine > 1.5 fold ULN; 3.Patients with severe heart disease, i.e. NYHA grade III-IV heart failure, unstable angina pectoris, myocardial infarction, underwent coronary artery reconstruction within 6 months before admission; 4.Patients with splenectomy or other serious hematopoietic system diseases; 5.Uncontrolled diabetes, hypertension (systolic blood pressure > 180mmhg and / or diastolic blood pressure > 120mmhg), uncontrollable infection, and severe peptic ulcer; 6.Mental patients without self-knowledge ability, those without legal capacity or limited legal capacity; 7.Patients who are pregnant, lactating or have the possibility of pregnancy and planned pregnancy; 8.Patients have participated in or are participating in other clinical studies in the past one month; 9.The researchers believe that there are any other unsuitable candidates. Determine other situations that may affect the clinical research and the interpretation of research results.

Design outcomes

Primary

MeasureTime frame
FACT-G scale;FACT-F scale;

Secondary

MeasureTime frame
Nutritional status (body mass index, hemoglobin, serum albumin, prealbumin, etc.);Physical condition (ECOG score);Therapeutic safety;

Countries

China

Contacts

Public ContactMa Hongbin

Department of Radiotherapy, the Second Affiliated Hospital, Xi'an Jiaotong University

mhbxian@126.com+86 13991845066

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026