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

NCT ID: NCT03751566

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2026-10-04

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.

Conditions

Malignant Tumor of Soft Tissue of Head, Face and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen A

Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.

Group Type: ACTIVE_COMPARATOR

Standard supportive therapy

Intervention Type: DRUG

Standard supportive therapy

Regimen B

Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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.

Standard supportive therapy

Intervention Type: DRUG

Standard supportive therapy

Interventions

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.

Intervention Type: OTHER

Standard supportive therapy

Standard supportive therapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk Memorial Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masaryk Memorial Cancer Institute

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Renata Hejnová, Msc

Role: CONTACT

renata.hejnova@mou.cz

+42054313 ext. 6232

Regina Demlová, MD,Ph.D.

Role: CONTACT

demlova@mou.cz

Facility Contacts

Radana Dymáčková, MD

Role: primary

radana.dymackova@mou.cz

+42054313 ext. 1130

References

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.

Reference Type: BACKGROUND

PMID: 22072272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21537645 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32597419 (View on PubMed)

Other Identifiers

MOU-001

Identifier Type: -

Identifier Source: org_study_id