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Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.


N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma, Breast Cancer

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Trial Information

Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.


Inclusion Criteria:



Healthy volunteers:

- Should be considered healthy, with no known relevant comorbidity.

- Patients should not be suffering from active malignancy or history of malignancy in
the past.

- Must be over 18 years.

- Must have ability to understand and provide a written informed consent.

Patients with hepatocellular carcinoma:

- Patients must be diagnosed with inoperable HCC.

- Presence of primary tumor or metastatic at the time of the procedure.

- Patients with liver cirrhosis should be restricted to Child-Pugh A or B.

- Patients with AFP> 400ng/ml and image feature does not require histopathological
confirmation. However, in patients with active serology B virus, this value must be
greater than AFP 4000 ng / ml. The remaining patients should have histological
confirmation of HCC.

- Patients may be under observation or treatment in the presence of systemic or
intra-hepatic.

- Must have ability to understand and provide a written informed consent.

Patients with Ductal Carcinoma Breast

- Patients must have a diagnosis of breast ductal carcinoma inoperable.

- The presence of the primary tumor or metastatic during the procedure.

- Patients may be under observation or in the presence of systemic or hormonal
treatment only.

- Must have ability to understand to provide a written informed consent.

Exclusion Criteria:

- Can not stop antihypertensive medications or beta-blockers for at least 48 hours or
being in possession of a pacemaker or other implantable device.

- Pregnant or lactating women.

- Smaller than 18 years.

- Patients undergoing radiotherapy treatment or up to 2 weeks of discontinuation.

- Inability to understand and provide written informed consent.

- Liver cirrhosis Child Pugh C.

- Patients without a definite diagnosis.

- Absence of the primary tumor or metastatic during the procedure.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Outcome Measure:

Autonomic response monitoring (blood pressure digital and manual monitoring)

Outcome Time Frame:

60 minutes

Safety Issue:

Yes

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

HSL 2012/01

NCT ID:

NCT01686412

Start Date:

July 2012

Completion Date:

March 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Breast Cancer
  • Breast Cancer
  • Hepatocellular carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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