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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Acupuncture
* Drug: Standard supportive therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regimen A<br>Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy. | Drug: Standard supportive therapy<br>* Standard supportive therapy<br>|
| Experimental: Regimen B<br>Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture. | Other: Acupuncture<br>* 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.<br>Drug: Standard supportive therapy<br>* Standard supportive therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy | Reducing the grade of acute toxicity in radiotherapy. | six months after the end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy | Lower incidence of chronic toxicity of radiotherapy. | six months after the end of radiotherapy |