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Investigation of Moxibustion Combined with Invigorating Qi and Warming Yang Tincture in Cancer-Related Fatigue: A Study Based on Metabolomics and Transcriptomics for Clinical Effects and Mechanism of Action

Exploring the Role of Moxibustion in ICIs-Related Cancer-Related Fatigue (CRF) Through Hypothalamic-Pituitary-Adrenal Axis Regulation: A Clinical and Mechanistic Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002269
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Cancer-related fatigue

Interventions

Control Group:Conventional symptomatic treatment with integrated Traditional Chinese and Western medicine
Observation of Group A:Moxibustion + symptomatic supportive therapy
Observation of Group B:Adopting Traditional Chinese Medicine invigorating qi and warming yang Tincture+Thunder Fire Moxibustion+Symptomatic supportive treatment

Sponsors

Shenzhen Hospital (Longgang), Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for the subjects in both traditional Chinese medicine (TCM) and Western medicine 2) Karnofsky Performance Status (KPS) = 60 points 3) Aged between 18 and 80 years old 4) Has clear consciousness, fully understands the content of the study, and voluntarily agrees to participate in this research 5) Has basically normal immune function, bone marrow reserve, and heart, liver, and kidney functions, with no history of primary endocrine diseases 6) Has an expected survival period of at least 3 months 7) Has good compliance, can maintain an independent position, and has good follow-up

Exclusion criteria

Exclusion criteria: 1) Patients with severe primary diseases of the cardiovascular, cerebrovascular, hematopoietic, autoimmune, or neuropsychiatric systems 2) Patients with local skin ulceration, infection, high fever, or severe systemic infections, or those with uncontrollable organic diseases 3) Pregnant or breastfeeding women, those planning pregnancy in the near future, or patients with (functional uterine bleeding) 4) Patients with severe allergies, those with allergies to the adjuvants or components of traditional Chinese medicine tincture for external use, or those allergic to the drugs in (a type of moxibustion), or those who experience (fainting during moxibustion) 5) Patients with active bleeding or severe coagulation disorders (e.g., glaucoma, retinal hemorrhage, or ocular bleeding due to trauma) 6) Patients currently using immunosuppressive drugs or those who have undergone organ transplantation and are on long-term immunosuppressive therapy 7) Patients with severe liver or kidney dysfunction (serum creatinine =1.5×ULN; ALT or AST =5×ULN; bilirubin =1.5×ULN) or those currently taking cephalosporin antibiotics (potential interaction with tinctures)

Design outcomes

Primary

MeasureTime frame
Piper Fatigue Scale Score;Quality of Life Assessment;

Secondary

MeasureTime frame
Performance Status Score;The quality of life scores for cancer patients;Traditional Chinese Medicine Syndrome Integral Evaluation;

Countries

China

Contacts

Public ContactLIU PENG

Shenzhen Hospital (Longgang), Beijing University of Chinese Medicine

liupeng11-29@163.com+86 18819322450

Outcome results

None listed

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