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Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00243607
First received: October 21, 2005
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Amenorrhea
Hot Flashes
 Other: hydrotherapy according to Kneipp rules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Menopausal complaints (MRS II) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol profile (saliva) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immediate treatment group (SBG)
immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)
 Other: hydrotherapy according to Kneipp rules
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
 Other: hydrotherapy according to Kneipp rules
2-5 applications of hydrotherapy according to Kneipp rules (self application) per day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243607

Locations
Germany
Ambulanz für Naturheilkunde und Integrative Medizin
Heidelberg, Baden-Württemberg, Germany, D-69115
Sponsors and Collaborators
University of Heidelberg
Charite University, Berlin, Germany
Investigators
Study Chair: Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD) Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus
  More Information

No publications provided

Responsible Party: Dr. Cornelia von Hagens, University of Heidelberg, Faculty of Medicine, University Womens Hospital
ClinicalTrials.gov Identifier: NCT00243607     History of Changes
Other Study ID Numbers: HD175-05
Study First Received: October 21, 2005
Last Updated: June 19, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
climacteric symptoms
breast cancer
hydrotherapy

Additional relevant MeSH terms:
Amenorrhea
Breast Neoplasms
Hot Flashes
Menstruation Disturbances
Pathologic Processes
 Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013