Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Standard supportive therapy
- Conditions
- Malignant Tumor of Soft Tissue of Head, Face and Neck
- Sponsor
- Masaryk Memorial Cancer Institute
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Curative and adjuvant radiotherapy for head and neck tumors;
- •Patient collaboration in evaluation of the toxicity diary.
Exclusion Criteria
- •Palliative radiotherapy in the head and neck tumor;
- •Non-compliance of the patient.
Arms & Interventions
Regimen A
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Intervention: Standard supportive therapy
Regimen B
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Intervention: Acupuncture
Regimen B
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Intervention: Standard supportive therapy
Outcomes
Primary Outcomes
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
- Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy(six months after the end of radiotherapy)