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	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
	Results Submission Events
February 23, 2020 June 19, 2020 October 7, 2020 October 28, 2020		Returned after QC review: March 6, 2020 Returned after QC review: July 2, 2020 Returned after QC review: October 28, 2020 (Canceled on October 29, 2020)
8	October 29, 2020	Study Status, Outcome Measures, Contacts/Locations, Document Section and Results
9	November 6, 2020	Study Status and Study Design
10	June 14, 2021	Document Section, Study Status, Eligibility and Study Description

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Study NCT01509612
Submitted Date: October 29, 2020 (v8)

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:

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]

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:

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.

Conditions


Conditions:	Malignant Tumors
Keywords:	cancer additive homeopathy patients with advanced malignant tumors

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]

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

Outcome Measures

[See Results Section.]


Primary Outcome Measures:
1.	EORTC-QLQ-C30 Score [ Time Frame: baseline and at 18 weeks ] 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.
Secondary Outcome Measures:
1.	Survival [ Time Frame: 2 years for the individual patient (=whole study duration) ] 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

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

Contacts/Locations


Study Officials:	Michael Frass, Prof. Dr. Principal Investigator Medical University Vienna
Locations:	Austria
	Michael Frass Wien, Austria, 1120

Study Results

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).

Arm/Group Title	Homeopathic Placebo Globules	Additive Classical Homeopathy in Cancer Patients	No Intervention Group
Arm/Group Description	Cancer patients received homeopathic placebo remedies	Lung cancer patients receive additive classical homeopathy with homeopathic remedies	The patients in this group received no intervention

Period Title: Overall Study
Started	47	51	52
Completed	47	51	52
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title

Additive Homeopathy in Cancer Patients

Additive Homeopathic Placebo Globules

No Intervention

Total

Arm/Group Description

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

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

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

Total of all reporting groups

Overall Number of Baseline Participants

150

Baseline Analysis Population Description

[Not Specified]

Age, Continuous

Mean (Standard Deviation)
Unit of measure: years

Number Analyzed

51 Participants

47 Participants

52 Participants

150 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 Analyzed

51 Participants

47 Participants

52 Participants

150 Participants

Female

49.02%

42.55%

46.15%

46%

Male

50.98%

57.45%

53.85%

54%

Race and Ethnicity Not Collected^[1]

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

51 Participants

47 Participants

52 Participants

150 Participants

[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 Analyzed

51 Participants

47 Participants

52 Participants

150 Participants

Austria

150

EORTC-QLQ-C30^[1]^[2]

Mean (Standard Deviation)
Unit of measure: units on a scale from 1 to 4

Number Analyzed

51 Participants

47 Participants

52 Participants

150 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.

Outcome Measures

1. Primary Outcome:

Title

EORTC-QLQ-C30 Score

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

Outcome Measure Data

Analysis Population Description

Data not collected for the no Intervention Group


Arm/Group Title	Homeopathic Placebo Globules	Additive Classical Homeopathy in Cancer Patients	No Intervention Group
Arm/Group Description	Cancer patients received homeopathic placebo remedies	Lung cancer patients receive additive classical homeopathy with homeopathic remedies	Lung cancer patients received conventional anti-cancer therapy, but neither homeopathic remedies nor homeopathic placebo globules. Data not collected for the no Intervention Group.
Overall Number of Participants Analyzed	47	51	0
Mean (Standard Deviation) Unit of Measure: score on a scale	51.2(28.0)	46.6(25.8)

Statistical Analysis 1


Statistical Analysis Overview	Comparison Group Selection	Homeopathic Placebo Globules, Additive Classical Homeopathy in Cancer Patients
	Comments	[Not specified]
	Type of Statistical Test	Superiority
	Comments	[Not specified]


Statistical Test of Hypothesis	P-Value	0.397
	Comments	[Not specified]
	Method	t-test, 2 sided
	Comments	[Not specified]

2. Secondary Outcome:

Title

Survival

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Additive Homeopathy in Cancer Patients	Additive Homeopathic Placebo Globules	No Intervention
Arm/Group Description	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	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 homeopathic or placebo intervention
Overall Number of Participants Analyzed	51	47	52
Measure Type: Number Unit of Measure: participants	23 45.1%	11 23.4%	7 13.5%

Statistical Analysis 1


Statistical Analysis Overview	Comparison Group Selection	Additive Homeopathy in Cancer Patients, Additive Homeopathic Placebo Globules
	Comments	Only those groups were compared who received an intervention
	Type of Statistical Test	Superiority
	Comments	[Not specified]


Statistical Test of Hypothesis	P-Value	0.02
	Comments	[Not specified]
	Method	Chi-squared
	Comments	[Not specified]

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.

Arm/Group Title	Homeopathic Placebo Globules	Additive Classical Homeopathy in Cancer Patients	No Intervention Group
Arm/Group Description	Cancer patients received homeopathic placebo remedies. Treatment emergent and serious adverse events were documented.	Lung cancer patients receive additive classical homeopathy with homeopathic remedies Treatment emergent and serious adverse events were documented.	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	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 (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	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%)

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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