Additive Homeopathy in Cancer Patients (HIC)

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Malignant Tumors

Treatments: Drug: Additive classical homeopathy; Drug: Homeopathic Placebo globules

Study type: Interventional

Funder types: Other

Identifiers

NCT01509612

5

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Additive homeopathy in cancer patients

Active Comparator group

Description:

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

Treatment:

Drug: Additive classical homeopathy

Additive homeopathic placebo globules

Placebo Comparator group

Description:

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

Treatment:

Drug: Homeopathic Placebo globules

No intervention

No Intervention group

Description:

No intervention