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Explore the clinical effect and mechanism of thunder fire moxibustion on cancer-related fatigue caused by immune checkpoint inhibitors based on invigorating qi and warming yang theory from hypothalamic pituitary adrenal axis regulation

Explore the clinical effect and mechanism of thunder fire moxibustion on cancer-related fatigue caused by immune checkpoint inhibitors based on invigorating qi and warming yang theory from hypothalamic pituitary adrenal axis regulation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006558
Enrollment
Unknown
Registered
2022-09-03
Start date
2022-09-02
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

Observation group:Traditional Chinese medicine tincture + thunder fire moxibustion + symptomatic support treatment
Control group:Routine 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: ? Meet the above diagnostic criteria of Traditional Chinese and western medicine; ? KPS=50 points; ? Aged between 18 and 80 years old; ? Have a clear sense of autonomy, fully know the research content, and voluntarily agree to participate in the research; ?Immune function bone marrow reserve and thyroid function of heart, liver, kidney, adrenal gland were basically normal, and there was no history of endocrine diseases. ?Prior systemic treatment with checkpoint inhibitors (ICIs) for more than 4 cycles; ?The expected survival time is 3 months or more; ?With good compliance, can be placed independent posture, good follow-up

Exclusion criteria

Exclusion criteria: ?Complicated with serious primary diseases such as cardio-cerebrovascular system or hematopoietic system, autoimmune system and psycho-nervous system; ?Associated with local skin ulceration infection, high fever and serious systemic infectious diseases; ?Women who are pregnant or breast-feeding or have a recent pregnancy plan, patients with disintegration; ?Patients receiving specialized treatment such as chemoradiotherapy and targeted therapy during the same period, or the washout period is less than 30 days; ?Severe allergic constitution, or definite allergy to excipients/excipients related to Chinese medicine transdermal patch technology, or drug components in thunder and fire moxibustion, or dizzy moxibustion; ?Patients with recent active bleeding or severe coagulation abnormalities (glaucoma, fundus bleeding, traumatic eye bleeding); ?Patients who are using immunosuppressive drugs or long-term use of immunosuppressive drugs after organ transplantation; ?During the use of cephalosporin antibiotics.

Design outcomes

Primary

MeasureTime frame
Piper Fatigue Scale;

Secondary

MeasureTime frame
Quality of life score for cancer patients;EORTC-QLQ-C30-version3;??????;

Countries

China

Contacts

Public ContactLiu Peng

Shenzhen Hospital (Longgang), Beijing University of Chinese Medicine

liupeng11-29@163.com0755-28338833-6602

Outcome results

None listed

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