Additive Homeopathy in Cancer Patients (HIC)

June 14, 2021 updated by: Michael Frass, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1120
        • Michael Frass

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and at 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years for the individual patient (=whole study duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael Frass, Prof. Dr., Medical University Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

January 7, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (ESTIMATE)

January 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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