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Additive Homeopathy in Cancer Patients (HIC)

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ClinicalTrials.gov Identifier: NCT01509612
Recruitment Status : Recruiting
First Posted : January 13, 2012
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment.

The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.


Condition or disease Intervention/treatment Phase
Malignant Tumors Drug: Additive classical homeopathy Drug: Homeopathic Placebo globules Phase 2 Phase 3

Detailed Description:
The EORTC-QLQ-C30 as well as a VAS scale for subjective well-being will be filled out by the patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Study Evaluating Quality of Life in Patients With Advanced Malignant Lung Tumors With or Without "add-on" Homeopathy
Study Start Date : January 2011
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Additive homeopathy in cancer patients
Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules
Drug: Additive classical homeopathy
Homeopathic remedies every 2 to 3 months
Other Name: Classical homeopathic remedies
Placebo Comparator: Additive homeopathic placebo globules
Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules
Drug: Homeopathic Placebo globules
Homeopathic placebo globules every 2 to 3 months
Other Name: Homeopathic Placebo globules looking identical to verum
No Intervention: No intervention
No intervention


Outcome Measures

Primary Outcome Measures :
  1. Life quality [ Time Frame: 7 years ]
    Life quality is evaluated by using the results of the EORTC-QLQ-C30 questionnaire


Secondary Outcome Measures :
  1. Survival [ Time Frame: 7 years ]
    Survival is evaluated by assessing time in months from diagnosis until death


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Informed consent
  • Clinical diagnosis of advanced tumor stages of glioblastoma IV, metastasized sarcoma, as well as non small-cell lung carcinoma (NSCLC) IV.

Exclusion Criteria:

  • Pregnant patients
Contacts and Locations

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): NCT01509612


Contacts
Contact: Michael Frass, Prof. Dr. +43 1 40400 ext 4506 michael.frass@meduniwien.ac.at

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, A 1090
Contact: Michael Frass, Prof. Dr.    +43 1 40400 ext 4506    michael.frass@meduniwien.ac.at   
Principal Investigator: Michael Frass, Prof. Dr.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Frass, Prof. Dr. Medical University Vienna
More Information

Additional Information:
Responsible Party: Michael Frass, Principal Investigator, Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01509612     History of Changes
Other Study ID Numbers: 5
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Frass, Medical University of Vienna:
cancer
additive homeopathy
patients with advanced malignant tumors

Additional relevant MeSH terms:
Neoplasms