An interventional study of Acupuncture and Standard supportive therapy in Malignant Tumor of Soft Tissue of Head, Face and Neck, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Treatment
The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in the therapy of acute toxicity of radiotherapy.
The study will enroll 100 patients in current radiotherapy of the head and neck cancer with acute radiotoxic symptoms at least of G1. The patients will be randomized (by ticket) in two regimens 1:1.
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Due to the disease and patients differences, treatment will be individualized. Used acupuncture points will be documented. The patients difficulties will be observed and their medication and will be recorded in the patient diary.
Possible skin toxicities wil be documented by the photography.
Before the randomization, all subjects will sign the voluntary informed consent. After the achievement of 50 enrolled subjects in any regimen, the enrollment will continue only to the other regimen.
Head and neck cancer therapy will include only curative and adjuvant radiotherapy.
Exclusion Criteria:
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Drug: Standard supportive therapy
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Other: Acupuncture · Drug: Standard supportive therapy
Schedule of the acupuncture: Acupuncture may be done ambulant or during hospitalisation . Acupuncture will be administered 1-3 times a week ( in case of severe toxicity and problems caused by the radiotherapy, it may continue also after the termination of the radiotherapy.) Acupuncture needles will be left for 5- 30 minutes, as per individual need of the patients. Acupuncture will be performed by a physician trained in acupuncture.
Standard supportive therapy
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
Reducing the grade of acute toxicity in radiotherapy.
Time frame: six months after the end of radiotherapy
Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
Lower incidence of chronic toxicity of radiotherapy.
Time frame: six months after the end of radiotherapy
Plan to share: No
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Masaryk Memorial Cancer Institute