Malignant TumorsPhase 3HICNCT01509612
Additive Homeopathy in Cancer Patients
A Phase 3 study testing Additive classical homeopathy in people with Malignant Tumors, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- Additive classical homeopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2012to 31 Jul 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Malignant Tumors
- Being tested
- Additive classical homeopathy, Homeopathic Placebo globules
- Keywords
- cancer, additive homeopathy, patients with advanced malignant tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additive classical homeopathyDrug
Also called Classical homeopathic remedies
Homeopathic remedies every 2 to 3 months
Homeopathic Placebo globulesDrug
Also called Homeopathic Placebo globules looking identical to verum
Homeopathic placebo globules every 2 to 3 months
| Study group | Role | What they receive |
|---|---|---|
| Additive homeopathy in cancer patients | Active comparator | Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules Receives: Drug: Additive classical homeopathy |
| Additive homeopathic placebo globules | Placebo comparator | Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules Receives: Drug: Homeopathic Placebo globules |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and at 18 weeks
Secondary outcomes (1)
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
Measured: 2 years for the individual patient (=whole study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study start1 Feb 2012
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Frass, Medical University of Vienna
- Investigators
- Michael Frass, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509612
- Sponsor's protocol ID
- 5
- Acronym
- HIC
- Status last verified
- Jun 2021
- First submitted
- 7 Jan 2012
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Frass M, Lechleitner P, Grundling C, Gaertner K, Duscheck C, Muchitsch I, Manchanda RK, Burghuber OC. Improved quality of life and prolonged survival with add-on homeopathic treatment in patients with non-small cell lung cancer: a prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter study. Support Care Cancer. 2026 Sep 10;34(10):952. doi: 10.1007/s00520-026-11154-3.
PubMed 42720799Frass 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.
PubMed 33010094
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01509612
- Acronym / sponsor ID
- HIC / 5
- Conditions
- Malignant Tumors
- Keywords
- cancer, additive homeopathy, patients with advanced malignant tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Additive homeopathy in cancer patients | Active comparator | Drug: Additive classical homeopathyLung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules |
| Additive homeopathic placebo globules | Placebo comparator | Drug: Homeopathic Placebo globulesLung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent
- Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additive classical homeopathyAlso: Classical homeopathic remediesHomeopathic remedies every 2 to 3 months | Drug | Additive homeopathy in cancer patients |
| Homeopathic Placebo globulesAlso: Homeopathic Placebo globules looking identical to verumHomeopathic placebo globules every 2 to 3 months | Drug | Additive homeopathic placebo globules |
Primary outcome
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.
1 secondary outcome
Survival
Time frame: 2 years for the individual patient (=whole study duration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42720799Frass M, Lechleitner P, Grundling C, Gaertner K, Duscheck C, Muchitsch I, Manchanda RK, Burghuber OC. Improved quality of life and prolonged survival with add-on homeopathic treatment in patients with non-small cell lung cancer: a prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter study. Support Care Cancer. 2026 Sep 10;34(10):952. doi: 10.1007/s00520-026-11154-3.
- Derived from this study: PubMed 33010094Frass 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.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frass, Prof. Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Additive classical homeopathy in people with Malignant Tumors, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC-QLQ-C30 Score (time frame: baseline and at 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509612, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.