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Completed

NCT Number: NCT01509612

Additive Homeopathy in Cancer Patients

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.

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Key information

Conditions

Malignant Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Michael Frass

Vienna, 1120, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additive classical homeopathy

Drug

Homeopathic remedies every 2 to 3 months

Other names: Classical homeopathic remedies

Homeopathic Placebo globules

Drug

Homeopathic placebo globules every 2 to 3 months

Other names: Homeopathic Placebo globules looking identical to verum

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Acronym: HIC

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2012
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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