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

Masaryk Memorial Cancer Institute

Status: Enrolling

Conditions: Malignant Tumor of Soft Tissue of Head, Face and Neck

Treatments: Other: Acupuncture; Drug: Standard supportive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03751566

MOU-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Regimen A

Active Comparator group

Description:

Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.

Treatment:

Drug: Standard supportive therapy

Regimen B

Experimental group

Description:

Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.

Treatment:

Drug: Standard supportive therapy

Other: Acupuncture