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NCT Number: NCT03751566

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

Location status: Recruiting

Location contact

Radana Dymáčková, MD

CONTACT

[email protected]

+42054313 ext. 1130

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Curative and adjuvant radiotherapy for head and neck tumors;
  • PS 1-2;
  • Patient collaboration in evaluation of the toxicity diary.

Exclusion criteria

  • Palliative radiotherapy in the head and neck tumor;
  • PS 3;
  • Non-compliance of the patient.

Treatment and study plan

Acupuncture

Other

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

Drug

Standard supportive therapy

Primary outcomes

  1. Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy

    Time frame: six months after the end of radiotherapy

    Reducing the grade of acute toxicity in radiotherapy.

Secondary outcomes

  1. Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy

    Time frame: six months after the end of radiotherapy

    Lower incidence of chronic toxicity of radiotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Regina Demlová, MD,Ph.D.

CONTACT

[email protected]

Renata Hejnová, Msc

CONTACT

[email protected]

+42054313 ext. 6232

Sponsors and collaborators

Lead sponsor

Masaryk Memorial Cancer Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Nov 23, 2018
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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