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RecruitingNCT03751566Updated Sep 25, 2025

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

An interventional study of Acupuncture and Standard supportive therapy in Malignant Tumor of Soft Tissue of Head, Face and Neck, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Curative and adjuvant radiotherapy for head and neck tumors;
  • PS 1-2;
  • Patient collaboration in evaluation of the toxicity diary.

Exclusion criteria

Exclusion Criteria:

  • Palliative radiotherapy in the head and neck tumor;
  • PS 3;
  • Non-compliance of the patient.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Regimen A

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

    Drug: Standard supportive therapy

  • Experimental
    Regimen B

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

    Other: Acupuncture · Drug: Standard supportive therapy

Interventions

  • OtherAcupuncture

    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.

  • DrugStandard supportive therapy

    Standard supportive therapy

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What researchers measure

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 radiotherapy

Secondary 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 radiotherapy

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Study locations

1 of 1 sites recruiting
  • Masaryk Memorial Cancer Institute
    Brno, 65653, Czechia
    Recruiting
07

References and documents

Publications

  • 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. PubMed 22072272 ↗
  • 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. PubMed 21537645 ↗
  • 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. PubMed 32597419 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03751566
Lead sponsor
Masaryk Memorial Cancer Institute
Responsible party
Sponsor
First posted
Nov 23, 2018
Start date
Oct 5, 2021
Primary completion
Sep 4, 2023
Completion
Oct 4, 2026 (estimated)
Last update
Sep 25, 2025

Study contacts

Renata Hejnová, Msc
Contact
renata.hejnova@mou.cz
+42054313 ext. 6232
Regina Demlová, MD,Ph.D.
Contact
demlova@mou.cz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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