Additive Homeopathy in Cancer Patients

Malignant Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509612
• Other study ID #: 5
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2012
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumors
• Neoplasms

Intervention

Drug:
• Additive classical homeopathy
Homeopathic remedies every 2 to 3 months
• Homeopathic Placebo globules
Homeopathic placebo globules every 2 to 3 months

Locations

Country	Name	City	State
Austria	Michael Frass	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and at 18 weeks
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	2 years for the individual patient (=whole study duration)

External Links

•   Related info