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Additive Homeopathy in Cancer Patients (HIC)

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ClinicalTrials.gov Identifier: NCT01509612
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : November 3, 2020
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Frass, Medical University of Vienna

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.


Condition or disease Intervention/treatment Phase
Malignant Tumors Drug: Additive classical homeopathy Drug: Homeopathic Placebo globules Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Homeopathic Placebo globules looking identical to verum

No Intervention: No intervention
No intervention



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509612


Locations
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Austria
Michael Frass
Wien, Austria, 1120
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Michael Frass, Prof. Dr. Medical University Vienna
  Study Documents (Full-Text)

Documents provided by Michael Frass, Medical University of Vienna:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Frass, Principal Investigator, Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01509612    
Other Study ID Numbers: 5
First Posted: January 13, 2012    Key Record Dates
Results First Posted: November 3, 2020
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Frass, Medical University of Vienna:
cancer
additive homeopathy
patients with advanced malignant tumors
Additional relevant MeSH terms:
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Neoplasms