NCT03751566

Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Masaryk Memorial Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in the therapy of acute toxicity of radiotherapy.

Detailed description

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.

Conditions

• Malignant Tumor of Soft Tissue of Head, Face and Neck

Interventions

Type	Name	Description
OTHER	Acupuncture	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.
DRUG	Standard supportive therapy	Standard supportive therapy

Timeline

• Start date: 2021-10-05
• Primary completion: 2023-09-04
• Completion: 2026-10-04
• First posted: 2018-11-23
• Last updated: 2025-09-25

Locations

1 site across 1 country: Czechia