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History of Changes for Study: NCT01509612
Additive Homeopathy in Cancer Patients (HIC)
Latest version (submitted June 14, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 10, 2012 None (earliest Version on record)
2 January 13, 2012 Outcome Measures, Study Status, Study Description, Sponsor/Collaborators and Study Identification
3 July 11, 2012 Study Status and Sponsor/Collaborators
4 February 10, 2015 Study Status and Arms and Interventions
5 July 27, 2016 Arms and Interventions, Study Status, IPDSharing, Contacts/Locations, Outcome Measures, Study Design and Study Identification
6 August 28, 2017 Study Status
7 August 15, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Results Submission Events
8 October 29, 2020 Study Status, Outcome Measures, Contacts/Locations, Documents and Results
9 November 6, 2020 Study Status and Study Design
10 June 14, 2021 Documents, Study Status, Eligibility and Study Description
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Study NCT01509612
Submitted Date:  January 13, 2012 (v2)

Open or close this module Study Identification
Unique Protocol ID: 5
Brief Title: Additive Homeopathy in Cancer Patients (HIC)
Official Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Study Evaluating Quality of Life in Patients With Advanced Malignant Tumors With or Without "add-on" Homeopathy
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2012
Overall Status: Recruiting
Study Start: January 2011
Primary Completion: January 2018 [Anticipated]
Study Completion: January 2019 [Anticipated]
First Submitted: January 7, 2012
First Submitted that
Met QC Criteria:
January 10, 2012
First Posted: January 13, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 13, 2012
Last Update Posted: January 18, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medical University of Vienna
Responsible Party: Principal Investigator
Investigator: Michael Frass
Official Title: Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients
Affiliation: Medical University of Vienna
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.

Detailed Description: The EORTC-QLQ-C30 as well as a VAS scale for subjective well-being will be filled out by the patients.
Open or close this module Conditions
Conditions: Malignant Tumors
Keywords: cancer
additive homeopathy
patients with advanced malignant tumors
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Additive homeopathy in cancer patients Drug: Additive classical homeopathy
Homeopathic remedies every 2 to 3 months
Other Names:
  • Classical homeopathic remedies
Placebo Comparator: Additive hom in cancer patients placebo
Patients of placebo group receive placebo homeopathic therapy
Drug: Placebo homeopathic globules
Homeopathic placebo globules every 2 to 3 months
Other Names:
  • Placebo homeopathic globules looking identical to verum
Drug: Placebo globules
saccharose globules and dilutions taken orally
Other Names:
  • Individually prepared homeopathic remedies
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Life quality
Life quaity is evaluated by using the results of the EORTC-QLQ-C30 questionnaire

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

[Time Frame: 7 years]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Michael Frass, Prof. Dr.
Telephone: +43 1 40400 Ext. 4506
Email: michael.frass@meduniwien.ac.at
Central Contact Backup: Cornelia Sax, MSc
Telephone: +43 1 40400 Ext. 4421
Email: cornelia.sax@meduniwien.ac.at
Study Officials: Michael Frass, Prof. Dr.
Principal Investigator
Medical University Vienna
Locations: Austria
Medical University Vienna
[Recruiting]
Vienna, Austria, A 1090
Contact:Contact: Michael Frass, Prof. Dr. +43 1 40400 Ext. 4506 michael.frass@meduniwien.ac.at
Contact:Principal Investigator: Michael Frass, Prof. Dr.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related info
Available IPD/Information:

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