Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

May 3, 2017 updated by: Cornelia von Hagens, Heidelberg University

Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy

Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease.

Hormone replacement therapy is contraindicated and other pharmacological options may also include the risk of stimulating hormone receptors. Hydrotherapy following the guidelines of naturopathy by S. Kneipp is a non-pharmacological treatment option which may influence climacteric symptoms by affecting the regulation of body temperature. In this study, the regular self application of hydrotherapy after initial training by a professional will be evaluated for its efficacy, practicability, and compatibility.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, D-69115
        • Ambulanz für Naturheilkunde und Integrative Medizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast cancer diagnosis
  • Menopausal complaints score > 14 (MRS II)
  • End of last chemotherapy or radiotherapy > 2 months
  • Expected stable disease for the next 6 months

Exclusion Criteria:

  • Regular intake of glucocorticoids
  • Regular practice of hydrotherapy before inclusion
  • Start or change of other treatments/changes of lifestyle in order to influence menopausal symptoms
  • Psychiatric disorders with possible influence on compliance and adherence to the protocol
  • Other severe or progressive diseases with influence on compliance and adherence to the protocol
  • Contraindications to hydrotherapy (severe heart failure, relevant dermatological diseases, Raynaud's Phenomenon [M. Raynaud], peripheral arterial occlusive disease Fontaine stage IIb [VK IIb] or more, acute thrombosis, or thrombophlebitis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate treatment group (SBG)
immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)
2-5 applications of hydrotherapy according to Kneipp rules (self application) per day
No Intervention: waiting group (WG)
start of hydrotherapy (self treatment) after waiting period of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Menopausal complaints (MRS II)
Time Frame: 12 and 24 weeks
12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cortisol profile (saliva)
Time Frame: 12 and 24 weeks
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD), Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

June 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • HD175-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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