Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additive homeopathy in cancer patients | Active Comparator | Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules |
|
| Additive homeopathic placebo globules | Placebo Comparator | Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules |
|
| No intervention | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additive classical homeopathy | Drug | Homeopathic remedies every 2 to 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| EORTC-QLQ-C30 Score | 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. | baseline and at 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 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 | 2 years for the individual patient (=whole study duration) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Frass, Prof. Dr. | Medical University Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Frass | Vienna | 1120 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33010094 | Derived | Frass M, Lechleitner P, Grundling C, Pirker C, Grasmuk-Siegl E, Domayer J, Hochmair M, Gaertner K, Duscheck C, Muchitsch I, Marosi C, Schumacher M, Zochbauer-Muller S, Manchanda RK, Schrott A, Burghuber O. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study. Oncologist. 2020 Dec;25(12):e1930-e1955. doi: 10.1002/onco.13548. Epub 2020 Nov 7. |
| Label | URL |
|---|---|
| Related info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Patients were recruited from February 2012 to July 2017
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Homeopathic Placebo Globules | Cancer patients received homeopathic placebo remedies |
| FG001 | Additive Classical Homeopathy in Cancer Patients | Lung cancer patients receive additive classical homeopathy with homeopathic remedies |
| FG002 | No Intervention Group | The patients in this group received no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Additive Homeopathic Placebo Globules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | EORTC-QLQ-C30 Score | 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. | Data not collected for the no Intervention Group | Posted | Mean | Standard Deviation | score on a scale | baseline and at 18 weeks |
|
The study for each participant lasted 24 months
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Homeopathic Placebo Globules | Cancer patients received homeopathic placebo remedies. Treatment emergent and serious adverse events were documented. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Frass, MD | Medical University of Vienna | +436645453040 | office@ordination-frass.at |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2014 | Jun 14, 2021 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Homeopathic Placebo globules | Drug | Homeopathic placebo globules 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| EORTC-QLQ-C30 | At baseline the quality of life questionnaire (EORTC-QLQ-C30) was completed by all participating subjects receiving placebo or homeopathy | 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. | Mean | Standard Deviation | units on a scale from 1 to 4 |
|
Lung cancer patients receive additive classical homeopathy with homeopathic remedies |
| OG002 | 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. |
|
|
|
| Secondary | Survival | 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 | Posted | Number | participants | 2 years for the individual patient (=whole study duration) |
|
|
|
|
| 11 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Additive Classical Homeopathy in Cancer Patients | Lung cancer patients receive additive classical homeopathy with homeopathic remedies Treatment emergent and serious adverse events were documented. | 23 | 51 | 0 | 51 | 0 | 51 |
| EG002 | No Intervention Group | Patients received no intervention. Treatment emergent and serious adverse events were documented. | 7 | 52 | 0 | 52 | 0 | 52 |
Not provided
Not provided
| Male |
|