Malignant Tumor of Soft Tissue of Head, Face and NeckNCT03751566
Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
A study testing Acupuncture and Standard supportive therapy in people with Malignant Tumor of Soft Tissue of Head, Face and Neck, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor of Soft Tissue of Head, Face and Neck
- What is being tested?
- Acupuncture and Standard supportive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Oct 2021to 4 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Curative and adjuvant radiotherapy for head and neck tumors;
- PS 1-2;
- Patient collaboration in evaluation of the toxicity diary.
Who cannot join
- Palliative radiotherapy in the head and neck tumor;
- PS 3;
- Non-compliance of the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Regina Demlová, MD,Ph.D. contact
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 65653
Radana Dymáčková, MD, +42054313 ext. 1130, radana.dymackova@mou.cz
About this study
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.
- Being tested
- Acupuncture, Standard supportive therapy
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard supportive therapyDrug
Standard supportive therapy
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Active comparator | Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy. Receives: Drug: Standard supportive therapy |
| Regimen B | Experimental | Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture. Receives: Other: Acupuncture; Drug: Standard supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
Reducing the grade of acute toxicity in radiotherapy.
Measured: 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.
Measured: six months after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start5 Oct 2021
- Primary completion4 Sep 2023
- Study completion4 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumor of Soft Tissue of Head, Face and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751566
- Sponsor's protocol ID
- MOU-001
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2018
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22072272Braga 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 21537645Dymackova 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT03751566
- Acronym / sponsor ID
- MOU-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Oct 2026 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Active comparator | Drug: Standard supportive therapyRegimen A (control regimen): standard support treatment of adverse events of the radiotherapy. |
| Regimen B | Experimental | Other: Acupuncture, Drug: Standard supportive therapyRegimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Curative and adjuvant radiotherapy for head and neck tumors;
- PS 1-2;
- Patient collaboration in evaluation of the toxicity diary.
Key exclusion criteria (3 listed)
- Palliative radiotherapy in the head and neck tumor;
- PS 3;
- Non-compliance of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureSchedule 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. | Other | Regimen B |
| Standard supportive therapyStandard supportive therapy | Drug | Regimen A, Regimen B |
Primary outcome
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
Time frame: six months after the end of radiotherapy
Reducing the grade of acute toxicity in radiotherapy.
1 secondary outcome
Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
Time frame: six months after the end of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 22072272Meng 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.
- Background: PubMed 21537645Braga 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.
- Derived from this study: PubMed 32597419Dymackova 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regina Demlová, MD,Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Standard supportive therapy in people with Malignant Tumor of Soft Tissue of Head, Face and Neck, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renata Hejnová, Msc (+42054313 ext. 6232, renata.hejnova@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy (time frame: six months after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751566, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.