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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Active Comparator | Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy. |
|
| Regimen B | Experimental | Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renata Hejnová, Msc | Contact | +42054313 | 6232 | renata.hejnova@mou.cz |
| Regina Demlová, MD,Ph.D. | Contact | demlova@mou.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masaryk Memorial Cancer Institute | Recruiting | Brno | 65653 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22072272 | Background | Meng Z, Garcia MK, Hu C, Chiang J, Chambers M, Rosenthal DI, Peng H, Zhang Y, Zhao Q, Zhao G, Liu L, Spelman A, Palmer JL, Wei Q, Cohen L. Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Cancer. 2012 Jul 1;118(13):3337-44. doi: 10.1002/cncr.26550. Epub 2011 Nov 9. | |
| 21537645 |
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| ID | Term |
|---|---|
| D019066 | Facies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Standard supportive therapy | Drug | Standard supportive therapy |
|
| Braga FP, Lemos Junior CA, Alves FA, Migliari DA. Acupuncture for the prevention of radiation-induced xerostomia in patients with head and neck cancer. Braz Oral Res. 2011 Mar-Apr;25(2):180-5. doi: 10.1590/s1806-83242011000200014. |
| 32597419 | Derived | Dymackova R, Kazda T, Slavik M, Selingerova I, Slampa P, Slama O. Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Dec;164(4):454-460. doi: 10.5507/bp.2020.021. Epub 2020 Jun 18. |