Additive Homeopathy in Cancer Patients

NCT01509612 | Completed Phase 3 Results

• 1 other identifier: 5
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumors

Keywords

cancer; additive homeopathy; patients with advanced malignant tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Survival

  2 years for the individual patient (=whole study duration)

Study Arms (3)

Additive homeopathy in cancer patients

ACTIVE COMPARATOR

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive additive classical homeopathy with homeopathic globules

Drug: Additive classical homeopathy

Additive homeopathic placebo globules

PLACEBO COMPARATOR

Lung cancer patients receiving conventional chemo- and/or radiation therapy receive homeopathic placebo globules

Drug: Homeopathic Placebo globules

No intervention

NO INTERVENTION

No intervention

Interventions

Additive classical homeopathy DRUG

Homeopathic remedies every 2 to 3 months

Also known as: Classical homeopathic remedies

Additive homeopathy in cancer patients

Homeopathic Placebo globules DRUG

Homeopathic placebo globules every 2 to 3 months

Also known as: Homeopathic Placebo globules looking identical to verum

Additive homeopathic placebo globules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Michael Frass

Vienna, 1120, Austria

Location

Related Publications (1)

• Frass 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.

  PMID: 33010094 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Michael Frass, MD
• Organization: Medical University of Vienna

office@ordination-frass.at

+436645453040

Study Officials

• Michael Frass, Prof. Dr.

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Prof. Dr., Director, Outpatient Unit Homeopathy in tumor patients

Study Record Dates

• First Submitted: January 7, 2012
• First Posted: January 13, 2012
• Study Start: February 1, 2012
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 16, 2021
• Results First Posted: November 3, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)