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

Primary Purpose

Malignant Tumor of Soft Tissue of Head, Face and Neck

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Acupuncture
Standard supportive therapy
Sponsored by
Masaryk Memorial Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Tumor of Soft Tissue of Head, Face and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Masaryk Memorial Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regimen A

Regimen B

Arm Description

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.

Outcomes

Primary Outcome Measures

Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
Reducing the grade of acute toxicity in radiotherapy.

Secondary Outcome Measures

Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
Lower incidence of chronic toxicity of radiotherapy.

Full Information

First Posted
November 15, 2018
Last Updated
November 21, 2018
Sponsor
Masaryk Memorial Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03751566
Brief Title
Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
Official Title
Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2016 (Actual)
Primary Completion Date
October 4, 2019 (Anticipated)
Study Completion Date
October 4, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk Memorial Cancer Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Tumor of Soft Tissue of Head, Face and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen A
Arm Type
Active Comparator
Arm Description
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Arm Title
Regimen B
Arm Type
Experimental
Arm Description
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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
Drug
Intervention Name(s)
Standard supportive therapy
Intervention Description
Standard supportive therapy
Primary Outcome Measure Information:
Title
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
Description
Reducing the grade of acute toxicity in radiotherapy.
Time Frame
six months after the end of radiotherapy
Secondary Outcome Measure Information:
Title
Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy
Description
Lower incidence of chronic toxicity of radiotherapy.
Time Frame
six months after the end of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Hejnová, Msc
Phone
+42054313
Ext
6232
Email
renata.hejnova@mou.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Demlová, MD,Ph.D.
Email
demlova@mou.cz
Facility Information:
Facility Name
Masaryk Memorial Cancer Institute
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radana Dymáčková, MD
Phone
+42054313
Ext
1130
Email
radana.dymackova@mou.cz

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22072272
Citation
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.
Results Reference
background
PubMed Identifier
21537645
Citation
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.
Results Reference
background
PubMed Identifier
32597419
Citation
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.
Results Reference
derived

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

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