NCT03751566

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2021Oct 2026

First Submitted

Initial submission to the registry

November 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
2.9 years until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2026

Expected
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

November 15, 2018

Last Update Submit

September 23, 2025

Conditions

Malignant Tumor of Soft Tissue of Head, Face and Neck

Outcome Measures

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.

    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

    six months after the end of radiotherapy

Study Arms (2)

Regimen A

ACTIVE COMPARATOR

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

Drug: Standard supportive therapy

Regimen B

EXPERIMENTAL

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

Other: AcupunctureDrug: Standard supportive therapy

Interventions

AcupunctureOTHER

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.

Regimen B
Standard supportive therapyDRUG

Standard supportive therapy

Regimen ARegimen B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22072272BACKGROUND

  • 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.

    PMID: 21537645BACKGROUND

  • 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.

    PMID: 32597419DERIVED

MeSH Terms

Conditions

Facies

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Renata Hejnová, Msc

CONTACT

+42054313renata.hejnova@mou.cz

Regina Demlová, MD,Ph.D.

CONTACT

demlova@mou.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 23, 2018

Study Start

October 5, 2021

Primary Completion

September 4, 2023

Study Completion (Estimated)

October 4, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)