NCT00861432

Brief Summary

Tumor patients receiving conventional tumor therapies are included into this study. The patients are randomized into two groups receiving either additive homeopathic therapy or not. Two questionnaires referring to subjective feeling and life quality are filled out by the patients with each visit to the outpatients Department. One of them is the QLQC30 questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

March 12, 2009

Last Update Submit

September 12, 2016

Conditions

Tumor

Keywords

Life qualityquestionnairetumor patients

Outcome Measures

Primary Outcomes (1)

  • Difference with regard to subjective feeling and life quality with or without homeopathic treatment

    3 months

Study Arms (2)

additive homeopathic treatment

ACTIVE COMPARATOR

These patients receive additive homeopathic treatment during conventional cancer treatment.

Other: additive homeopathic treatment

no additive homeopathic treatment

NO INTERVENTION

These patients do not receive additive homeopathic treatment during conventional cancer treatment.

Interventions

additive homeopathic treatmentOTHER

These patients receive additive homeopathic treatment

Also known as: homeopathic remedies according to the Pharmacopoeia
additive homeopathic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tumor patients between 18 and 100 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Med. Univ. Vienna, Dept. Internal Med. I

Vienna, Vienna, A1090, Austria

Location

Related Publications (1)

  • Frass M, Friehs H, Thallinger C, Sohal NK, Marosi C, Muchitsch I, Gaertner K, Gleiss A, Schuster E, Oberbaum M. Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial. Complement Ther Med. 2015 Jun;23(3):309-17. doi: 10.1016/j.ctim.2015.03.004. Epub 2015 Mar 23.

    PMID: 26051564DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Michael Frass, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

December 1, 2008

Primary Completion

July 1, 2010

Study Completion

April 1, 2011

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)