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A real-world study of Shengbai oral liquid in the prevention and treatment of cancer-related fatigue after chemotherapy in patients with malignant tumor

A real-world study of Shengbai oral liquid in the prevention and treatment of cancer-related fatigue after chemotherapy in patients with malignant tumor

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2200006057
Enrollment
Unknown
Registered
2022-06-04
Start date
2022-06-09
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

Cancer-related fatigue

Interventions

Treatment group:Conventional treatment + Shengbai oral liquid
Control group:Conventional treatment

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.The estimated survival period is more than 3 months, aged =18 years old, male or female; 2.Patients with malignant tumor diagnosed by pathology or cytology, and have undergone =1 cycle of chemotherapy, targeted therapy, immunotherapy or radiation therapy; 3.Patients who meet the diagnostic criteria of cancer-related fatigue (refer to the diagnostic criteria of cancer-related fatigue proposed in 2018 NCCN Clinical Practice Guidelines), and Piper fatigue scale score=4 points; 4.Clear consciousness, can communicate normally, and can cooperate with medical staff to complete questionnaires and physical examinations and assessments; 5.Patients who voluntarily accept the treatment of this clinical trial, who can insist on follow-up visits as prescribed by the doctor, and have good compliance.

Exclusion criteria

Exclusion criteria: 1.Patients with severe primary diseases of heart, lung, liver, kidney, hematopoietic system, endocrine system, etc. and the condition is unstable [severe liver and kidney dysfunction (ALT and AST are 3 times higher than ULN, Cr and BUN are 1.5 times higher than ULN), hemoglobin <80 g/L or platelets <50×109/L or neutrophils <1.0×109/L, NYHA grade IV, multiple organ failure, cachexia, etc.] 2.Patients with other diseases that may cause fatigue, such as muscular dystrophy, muscle weakness caused by uncontrolled endocrine, metabolic diseases or neurological diseases; 3.Patients who use steroids systemically due to chronic skin rashes, autoimmune diseases, etc. (regular doses of dexamethasone are allowed for antiemetic and other treatments); 4.TCM syndrome differentiation are yin deficiency and fire exuberance syndrome and heat toxic syndrome, and those with bleeding tendency; 5.Patients who are unable to cooperate, such as those with neurological or psychiatric disorders, or those who are unwilling to cooperate; 6.Patients who have participated or currently participating in other clinical trials within 1 months; 7.People who are allergic to the drugs used in this clinical trial, or with allergic constitution, or allergic to multiple drugs; 8.Pregnant or breastfeeding women, or those of childbearing age (including men) who are unwilling to take contraceptive measures; 9.Patients who are judged by researchers to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Total score of Piper fatigue scale;

Secondary

MeasureTime frame
Total score of Piper fatigue scale;The number of chemotherapy cycles completed;Total number of white blood cells, neutrophils, platelets and red blood cells;Total score of traditional Chinese medicine symptoms (MDASI-TCM criteria);Subgroup analysis: (1) Patients with normal white blood cells. (2) Patients with leukopenia: ?patients who have previously received effective white blood cell count-increasing treatments; ?patients who have previously received ineffective white blood cell count-increasing treatments.;

Countries

China

Contacts

Public ContactLong Shunqin
thinkinglong@126.com13688896122

Outcome results

None listed

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