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

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ClinicalTrials.gov Identifier: NCT03751566
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Masaryk Memorial Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Malignant Tumor of Soft Tissue of Head, Face and Neck Other: Acupuncture Drug: Standard supportive therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
Actual Study Start Date : April 4, 2016
Estimated Primary Completion Date : October 4, 2019
Estimated Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Active Comparator: Regimen A
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Drug: Standard supportive therapy
Standard supportive therapy

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy [ Time Frame: six months after the end of radiotherapy ]
    Lower incidence of chronic toxicity of radiotherapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751566


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

Locations
Czechia
Masaryk Memorial Cancer Institute Recruiting
Brno, Czechia, 65653
Contact: Radana Dymáčková, MD    +42054313 ext 1130    radana.dymackova@mou.cz   
Sponsors and Collaborators
Masaryk Memorial Cancer Institute

Publications:
Responsible Party: Masaryk Memorial Cancer Institute
ClinicalTrials.gov Identifier: NCT03751566     History of Changes
Other Study ID Numbers: MOU-001
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Soft Tissue Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type