Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasaryk Memorial Cancer Institute
About this trial
The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in the therapy of acute toxicity of radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Curative and adjuvant radiotherapy for head and neck tumors;
PS 1-2;
Patient collaboration in evaluation of the toxicity diary.
Disqualifiers
Palliative radiotherapy in the head and neck tumor;
PS 3;
Non-compliance of the patient.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Other interventionSchedule 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
DrugStandard supportive therapy
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Regimen AActive comparator 1 intervention
Group B: Regimen BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
Reducing the grade of acute toxicity in radiotherapy.
Time frame
six months after the end of radiotherapySecondary outcomes
1
Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
Lower incidence of chronic toxicity of radiotherapy.
Time frame
six months after the end of radiotherapySponsors and contacts
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Source ClinicalTrials.gov