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

Malignant Tumor of Soft Tissue of Head, Face and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751566
• Other study ID #: MOU-001
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2016
• Est. completion date: October 4, 2019

Study information

• Verified date: November 2018
• Source: Masaryk Memorial Cancer Institute
• Contact: Renata Hejnová, Msc
• Phone: +42054313
• Email: renata.hejnova[@]mou.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Malignant Tumor of Soft Tissue of Head, Face and Neck
• Neoplasms
• Sarcoma
• Soft Tissue Neoplasms

Intervention

Other:
• Acupuncture
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.

Drug:
• Standard supportive therapy
Standard supportive therapy

Locations

Country	Name	City	State
Czechia	Masaryk Memorial Cancer Institute	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Memorial Cancer Institute

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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