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Trial registered on ANZCTR


Registration number
ACTRN12609000101280
Ethics application status
Approved
Date submitted
27/11/2008
Date registered
13/02/2009
Date last updated
13/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for prevention of radiation-induced xerostomia in patients with head and neck cancer
Scientific title
The effect of acupuncture on objective and subjective salivary flow rates aspects for prevention of radiation-induced xerostomia in patients with head and neck cancer
Universal Trial Number (UTN)
Trial acronym
acupuncture radiotherapy xerostomia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
radiation-induced xerostomia 4033 0
Condition category
Condition code
Alternative and Complementary Medicine 4236 4236 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 4238 4238 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 4524 4524 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients submitted to radiotherapy (RT) with curative intend for head and neck cancer, receiving at least 5000 cGy irradiation total dose delivered to the bilateral area involving the major salivary glands. Patients will receive preventive acupuncture treatment (PAT), performed by the same clinician, twice a week, in a 2 - 3 weeks period before RT (4 - 6 sessions) and, in a 6 - 7 weeks period concomitantly with RT (12 – 14 sessions), totalizing 16 – 20 acupuncture sessions. The duration of each acupuncture session is 20 minutes. The acupoints used at our protocol were selected according to traditional Chinese and occidental orthodox medicine’s principles, and it included local, distal and auricular points, named in accordance with the WHO Standard Acupuncture Nomenclature.
Intervention code [1] 3755 0
Prevention
Comparator / control treatment
Control cohort. Patients submitted to RT with curative intend for head and neck cancer, receiving =5000 cGy irradiation total dose delivered to bilateral head and neck fields involving major salivary glands, given in fractional daily doses of 180 to 200 cGy, five days a week, during a period of 33 and 35 days. Patients did not receive concomitant acupuncture or any other therapy with preventive intend to minimize irradiation side effects. The latency post-RT xerostomia period up to ten years. Following the baseline collected data of saliva collection and questionnaires, patients enrolled in the CT group were ask to receive acupuncture treatment (post-RT acupuncture treatment protocol).
Control group
Active

Outcomes
Primary outcome [1] 5382 0
minimizing the severity of hyposalivation and related symptoms, measured by means of saliva collection and questionnaires, respectively.
Timepoint [1] 5382 0
Measurements for each patient will be performed in three occasions, at baseline (before RT), 2 week (during RT) and 6 - 7 week (after RT completion).
Secondary outcome [1] 9050 0
Feasibility of acupuncture among those patients by means of questionnaires.
Timepoint [1] 9050 0
After radiotherapy and acupuncture treatments.

Eligibility
Key inclusion criteria
Patients with head and neck malignancies requiring external beam RT, with planning of 5000 cGy or superior cumulative total doses delivered to the head and neck area involving the major salivary glands.
Minimum age
21 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with history of salivary gland disorder;
use of medication known to affect the function of the salivary glands.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Eligible patients will be assigned into two groups; experimental group (PAT), composed by individuals receiving RT and acupuncture before and during irradiation period, and control group (CT), composed by individuals already treated with RT, and did not received acupuncture or any other therapy with preventive intend to minimize irradiation side effects. The CT group will receive acupuncture treatment soon after the first visit, following the baseline collected data of saliva collection and questionnaires.
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1418 0
Brazil
State/province [1] 1418 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 4215 0
University
Name [1] 4215 0
Sao Paulo University
Address [1] 4215 0
Prof Lineu Prestes Av, 2227 Sao Paulo PC
05508-000
Country [1] 4215 0
Brazil
Primary sponsor type
University
Name
Sao Paulo University
Address
Prof Lineu Prestes Av, 2227 Sao Paulo PC
05508-000
Country
Brazil
Secondary sponsor category [1] 3789 0
Government body
Name [1] 3789 0
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES)
Address [1] 3789 0
Ministerio da Educacao, anexos I e II, Brasilia, DF, PC 70359-970
Country [1] 3789 0
Brazil
Other collaborator category [1] 497 0
Hospital
Name [1] 497 0
Instituto Brasileiro de Controle do Cancer (IBCC)
Address [1] 497 0
Alcantara Machado Av, 2576 Sao Paulo PC
Country [1] 497 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6269 0
Instituto Brasileiro de Controle do Cancer (IBCC) Ethics Committee
Ethics committee address [1] 6269 0
Alcantara Machado Av, 2576 Sao Paulo PC
Ethics committee country [1] 6269 0
Brazil
Date submitted for ethics approval [1] 6269 0
Approval date [1] 6269 0
13/02/2004
Ethics approval number [1] 6269 0
Ethics committee name [2] 6270 0
Sao Paulo University, School of Dentistry Ethics Committee
Ethics committee address [2] 6270 0
Prof Lineu Prestes Av, 2227 Sao Paulo PC 05508-000
Ethics committee country [2] 6270 0
Brazil
Date submitted for ethics approval [2] 6270 0
Approval date [2] 6270 0
07/06/2004
Ethics approval number [2] 6270 0

Summary
Brief summary
Despite benefits of radiotherapy for head and neck cancer, oral sequelae occur, especially xerostomia, considered the most frequently, and potential debilitating side effect. Although extensively studied, treatment approaches including acupuncture therapy are considered primarily palliative, administered only after hyposalivation and xerostomia related symptoms is already present. The aim of this study was to investigate if the preventive acupuncture treatment (PAT), an innovative method using acupuncture before and during RT is effective in minimizing the severe radiation-induced xerostomia for patients with head and neck cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29170 0
Address 29170 0
Country 29170 0
Phone 29170 0
Fax 29170 0
Email 29170 0
Contact person for public queries
Name 12327 0
Dante Antonio Migliari
Address 12327 0
Prof Lineu Prestes Av, 2227 Sao Paulo PC 05508-000
Country 12327 0
Brazil
Phone 12327 0
(xx 55 – 11) 3091-7883
Fax 12327 0
(xx 55 – 11) 3091-7883
Email 12327 0
damiglia@usp.br
Contact person for scientific queries
Name 3255 0
Fabio do Prado Florence Braga
Address 3255 0
Prof Lineu Prestes Av, 2227 Sao Paulo PC 05508-000
Country 3255 0
Brazil
Phone 3255 0
(xx 55 – 11) 3091-7883
Fax 3255 0
(xx 55 – 11) 3091-7883
Email 3255 0
fbraga@usp.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary