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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:  October 29, 2020 (v8)

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 Lung Tumors With or Without "add-on" Homeopathy
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Completed
Study Start: February 1, 2012
Primary Completion: July 31, 2019 [Actual]
Study Completion: July 31, 2019 [Actual]
First Submitted: January 7, 2012
First Submitted that
Met QC Criteria:
January 10, 2012
First Posted: January 13, 2012 [Estimate]
Results First Submitted: February 23, 2020
Results First Submitted that
Met QC Criteria:
October 29, 2020
Results First Posted: November 3, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 29, 2020
Last Update Posted: November 3, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Medical University of Vienna
Responsible Party: Principal Investigator
Investigator: Michael Frass
Official Title: Principal Investigator, 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: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 150 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • Homeopathic Placebo globules looking identical to verum
No Intervention: No intervention
No intervention
Open or close this module Outcome Measures
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
Study Officials: Michael Frass, Prof. Dr.
Principal Investigator
Medical University Vienna
Locations: Austria
Michael Frass
Wien, Austria, 1120
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links: Description: Related info
Available IPD/Information:

Open or close this module Documents
Study Protocol and Statistical Analysis Plan
Document Date: January 10, 2011
Uploaded: 09/18/2019 06:51
File Name: Prot_SAP_000.pdf

Study Results
Open or close this module Participant Flow
Recruitment Details Patients were recruited from February 2012 to July 2017
Pre-assignment Details Screened participants were excluded from participation in the study when mutations had been observed, these were treated as screening failures and not included in the trial (= not randomized, n=8).
Reporting Groups
Description
Homeopathic Placebo Globules Cancer patients received homeopathic placebo remedies
Additive Classical Homeopathy in Cancer Patients Lung cancer patients receive additive classical homeopathy with homeopathic remedies
No Intervention Group The patients in this group received no intervention
Overall Study
  Homeopathic Placebo Globules Additive Classical Homeopathy in Cancer Patients No Intervention Group
Started 47 51 52
Completed 47 51 52
Not Completed 0 0 0
Open or close this module Baseline Characteristics
Reporting Groups
Description
Additive Homeopathy in Cancer Patients

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules

Additive classical homeopathy: Homeopathic remedies every 2 to 3 months

Additive Homeopathic Placebo Globules

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules

Homeopathic Placebo globules: Homeopathic placebo globules every 2 to 3 months

No Intervention Lung cancer patients receiving conventional chemo- and/or radiation therapy but neither homeopathic remedies nor homeopathic placebo globules, these patients served as a non-intervention control group
Baseline Measures
    Additive Homeopathy in Cancer Patients Additive Homeopathic Placebo Globules No Intervention Total
Overall Number of Participants 51 47 52 150
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed51 Participants47 Participants52 Participants150 Participants
63.2(8.8)62.5(8.9)63.9(9.1)63.2(8.9)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed51 Participants47 Participants52 Participants150 Participants
Female25 49.02%20 42.55%24 46.15%69 46%
Male26 50.98%27 57.45%28 53.85%81 54%
Race and Ethnicity Not Collected [1]
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed51 Participants47 Participants52 Participants150 Participants
0
 
[1]

Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed51 Participants47 Participants52 Participants150 Participants
Austria
514752150
EORTC-QLQ-C30 [1] [2]
Mean (Standard Deviation)
Unit of measure: units on a scale from 1 to 4
Number Analyzed51 Participants47 Participants52 Participants150 Participants
46.6(25.8)51.2(28.0)48.8(26.8)
 
[1]

Measure Description: At baseline the quality of life questionnaire (EORTC-QLQ-C30) was completed by all participating subjects receiving placebo or homeopathy

[2]

Measure Analysis Population Description: The quality of life assessment was done in the two intervention groups (homeopathy or placebo), but was not done in control patients who received no intervention.Therefore, no data are presented for the "No Intervention" group.

Open or close this module Outcome Measures
1. Primary Outcome Measure:
Measure Title EORTC-QLQ-C30 Score
Measure Description

Quality of life was evaluated by using the Global Health Status assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), which was completed by participants throughout the study.

The score of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status.

Time Frame baseline and at 18 weeks
Analysis Population Description
Data not collected for the no Intervention Group
Reporting Groups
Description
Homeopathic Placebo Globules Cancer patients received homeopathic placebo remedies
Additive Classical Homeopathy in Cancer Patients Lung cancer patients receive additive classical homeopathy with homeopathic remedies
No Intervention Group Lung cancer patients received conventional anti-cancer therapy, but neither homeopathic remedies nor homeopathic placebo globules. Data not collected for the no Intervention Group.
Measured Values
  Homeopathic Placebo Globules Additive Classical Homeopathy in Cancer Patients No Intervention Group
Overall Number of Participants Analyzed47 51 0
EORTC-QLQ-C30 Score
Measure Type: Mean (Standard Deviation)
Unit of Measure: score on a scale
51.2 (28.0) 46.6 (25.8)
Statistical Analysis 1 for EORTC-QLQ-C30 Score
Statistical Analysis OverviewComparison GroupsHomeopathic Placebo Globules, Additive Classical Homeopathy in Cancer Patients
Comments[Not specified]
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.397
Comments[Not specified]
Methodt-test, 2 sided
Comments[Not specified]
2. Secondary Outcome Measure:
Measure Title Survival
Measure Description Survival was assessed by chart review, at every study visit (every 9 weeks throughout the trial), and by information of the central mortality registry of Austria
Time Frame 2 years for the individual patient (=whole study duration)
Analysis Population Description
[Not Specified]
Reporting Groups
Description
Additive Homeopathy in Cancer Patients

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules

Additive classical homeopathy: Homeopathic remedies every 2 to 3 months

Additive Homeopathic Placebo Globules

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules

Homeopathic Placebo globules: Homeopathic placebo globules every 2 to 3 months

No Intervention No homeopathic or placebo intervention
Measured Values
  Additive Homeopathy in Cancer Patients Additive Homeopathic Placebo Globules No Intervention
Overall Number of Participants Analyzed51 47 52
Survival
Measure Type: Number
Unit of Measure: participants
23 45.1% 11 23.4% 7 13.46%
Statistical Analysis 1 for Survival
Statistical Analysis OverviewComparison GroupsAdditive Homeopathy in Cancer Patients, Additive Homeopathic Placebo Globules
CommentsOnly those groups were compared who received an intervention
Type of Statistical TestSuperiority
Comments[Not specified]
Statistical Test of HypothesisP-Value0.02
Comments[Not specified]
MethodChi-squared
Comments[Not specified]
Open or close this module Reported Adverse Events
Time Frame The study for each participant lasted 24 months
Adverse Event Reporting Description

The adverse events reporting in this study differed from the definition of clinicaltrials.gov.

Treatment-related (serious) and non-treatment-related adverse events have been reported.

No severe treatment-related (serious) or non-treatment-related adverse event has been identified attributed to the study medication.

Reporting Groups
Description
Homeopathic Placebo Globules

Cancer patients received homeopathic placebo remedies.

Treatment emergent and serious adverse events were documented.

Additive Classical Homeopathy in Cancer Patients

Lung cancer patients receive additive classical homeopathy with homeopathic remedies

Treatment emergent and serious adverse events were documented.

No Intervention Group

Patients received no intervention.

Treatment emergent and serious adverse events were documented.

All-Cause Mortality
  Homeopathic Placebo Globules Additive Classical Homeopathy in Cancer Patients No Intervention Group
 Affected/At Risk (%)Affected/At Risk (%)Affected/At Risk (%)
Total All-Cause Mortality 11 / 47 (23.4%)23 / 51 (45.1%)7 / 52 (13.46%)
Serious Adverse Events
  Homeopathic Placebo Globules Additive Classical Homeopathy in Cancer Patients No Intervention Group
 Affected/At Risk (%)Affected/At Risk (%)Affected/At Risk (%)
Total 0 / 47 (0%)0 / 51 (0%)0 / 52 (0%)
Other Adverse Events
Frequency Threshold Above Which Other Adverse Events are Reported: 1%
  Homeopathic Placebo Globules Additive Classical Homeopathy in Cancer Patients No Intervention Group
 Affected/At Risk (%)Affected/At Risk (%)Affected/At Risk (%)
Total 0 / 47 (0%)0 / 51 (0%)0 / 52 (0%)
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title: Michael Frass, MD
Organization: Medical University of Vienna
Phone: +436645453040
Email: office@ordination-frass.at

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