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

Not Applicable

• Conditions: Malignant Tumor of Soft Tissue of Head, Face and Neck
• Interventions: Drug: Standard supportive therapy; Other: Acupuncture

• Registration Number: NCT03751566
• Lead Sponsor: Masaryk Memorial Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2016-04-04
• Status Verified: 2018-11
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen A	Standard supportive therapy	Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Regimen B	Acupuncture	Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Regimen B	Standard supportive therapy	Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.

Primary Outcome Measures

Name	Time	Method
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy	six months after the end of radiotherapy	Reducing the grade of acute toxicity in radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy	six months after the end of radiotherapy	Lower incidence of chronic toxicity of radiotherapy.

Trial Locations

Locations (1)

Masaryk Memorial Cancer Institute; 🇨🇿 Brno, Czechia