Malignant Tumors
Conditions
Keywords
cancer, additive homeopathy, patients with advanced malignant tumors
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, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.
Interventions
DRUGAdditive classical homeopathy
Homeopathic remedies every 2 to 3 months
DRUGHomeopathic Placebo globules
Homeopathic placebo globules every 2 to 3 months
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.
Exclusion criteria
* sensitizing mutation of the EGFR gene or translocation of the ALK gene * refusal to sign informed consent * pregnancy * hematological, hepatic, or renal pathology * coronary heart disease * history of secondary tumor * major surgery within 4 weeks prior to study entry * active infection and symptomatic peripheral neuropathy * central nervous system metastases unless the metastases were treated and stable * active autoimmune disease * use of systemic immunosuppressive treatment * use of systemic treatment during the previous 2 years * active interstitial lung disease, or a history of pneumonitis for which glucocorticoids were prescribed * previous systemic therapy for metastatic disease or previous irradiation * use of any complementary and/or alternative therapy, including homeopathy other than the research treatment during the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC-QLQ-C30 Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Survival | 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 |
Countries
Austria
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| 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 | 47 |
| 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 | 52 |
| Total | 150 |
Baseline characteristics
| Characteristic | Additive Homeopathy in Cancer Patients | Additive Homeopathic Placebo Globules | No Intervention | Total |
|---|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 8.8 | 62.5 years STANDARD_DEVIATION 8.9 | 63.9 years STANDARD_DEVIATION 9.1 | 63.2 years STANDARD_DEVIATION 8.9 |
| EORTC-QLQ-C30 | 46.6 units on a scale from 1 to 4 STANDARD_DEVIATION 25.8 | 51.2 units on a scale from 1 to 4 STANDARD_DEVIATION 28 | — | 48.8 units on a scale from 1 to 4 STANDARD_DEVIATION 26.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Austria | 51 participants | 47 participants | 52 participants | 150 participants |
| Sex: Female, Male Female | 25 Participants | 20 Participants | 24 Participants | 69 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 28 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 11 / 47 | 23 / 51 | 7 / 52 |
| other Total, other adverse events | 0 / 47 | 0 / 51 | 0 / 52 |
| serious Total, serious adverse events | 0 / 47 | 0 / 51 | 0 / 52 |
Outcome results
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.
Time frame: baseline and at 18 weeks
Population: Data not collected for the no Intervention Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Homeopathic Placebo Globules | EORTC-QLQ-C30 Score | 51.2 score on a scale | Standard Deviation 28 |
| Additive Classical Homeopathy in Cancer Patients | EORTC-QLQ-C30 Score | 46.6 score on a scale | Standard Deviation 25.8 |
p-value: 0.397t-test, 2 sided
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
Time frame: 2 years for the individual patient (=whole study duration)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Homeopathic Placebo Globules | Survival | 23 participants |
| Additive Classical Homeopathy in Cancer Patients | Survival | 11 participants |
| No Intervention Group | Survival | 7 participants |
Comparison: Only those groups were compared who received an interventionp-value: 0.02Chi-squared