Skip to content

Clinical study of transcutaneous electrical stimulation of acupoints combined with intradermal needling for the prevention of acute moderate to severe radiation pneumonitis

Clinical study of transcutaneous electrical stimulation of acupoints combined with intradermal needling for the prevention of acute moderate to severe radiation pneumonitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000177
Enrollment
Unknown
Registered
2024-08-06
Start date
2022-10-31
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

radiation pneumonitis

Interventions

control subjects:Radiotherapy only
treatment group:Transcutaneous electrical stimulation of acupoints combined with intradermal needling

Sponsors

Tianjin Cancer Hospital Airport Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Age range: male and female patients between the ages of 18 and 80 years old who are ready to receive radiation therapy and meet the clinical diagnostic criteria for lung cancer; (2) Functional status score: patients need to have a Karnofsky Performance Status (KPS) score of 70 or more, indicating that the patient has a good ability to perform daily activities to live a better self-care; (3) Survival expectancy: based on the physician's assessment, the patient's expected survival needs to be at least 6 months to ensure that there is sufficient time to evaluate the treatment effect; (4) Dose of radiotherapy: The radiotherapy plan that the patient will receive should have a single irradiation dose range of DT1.5 to 3.0 Gy/day to lung tissue and a total dose between 45 Gy and 60 Gy; (4) Informed consent: patients must be willing and able to comply with the trial requirements, including signing an informed consent form indicating an understanding of the purpose, procedures, and possible risks and benefits of the trial, which ensures the ethical and compliant nature of the study; (5) Other clinical trials: participants were not involved in any other clinical trials prior to the start of this trial to avoid interfering with the accuracy of the results; (6) Ensuring the absence of major complications: the patient has no major complications such as severe heart disease, kidney disease or liver disease to minimize potential risks during treatment; (7) Specific lung cancer type and stage: all types of lung cancer with a clear diagnosis, without limiting the types of lung cancer (e.g. non-small cell lung cancer, small cell lung cancer) and their clinical stages.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Allergic exclusion: this includes those with known allergies to any materials used in the study, such as electrode pads and intradermal needles; (2) Prior treatment history: patients with a history of regional radiotherapy to the chest are excluded to prevent prior treatment from influencing the results of this study; (3) Serious comorbidities: patients with significant organ dysfunction such as pulmonary, cardiac, hepatic or renal dysfunction or with severe infections; (4) Contraindications to radiotherapy: the presence of acute infections, pregnancy, interstitial pneumonia or immunologic pneumonia, severe mental illness and other contraindications to radiotherapy; (5) Inability (refusal) to participate in follow-up visits; (6) Patients with low compliance and non-adherence to the trial protocol.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation pneumonitis;

Secondary

MeasureTime frame
Radiation Pneumonia Classification;Chinese Medicine Symptom Scale Score;KPS scale scores;QLQ-LC43 scale score;ZPS scale score;

Countries

China

Contacts

Public ContactYuanyuan Cen

Tianjin University of Chinese Medicine

913742546@qq.com+86 15251774771

Outcome results

None listed

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