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Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243607
First Posted: October 24, 2005
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Cornelia von Hagens, Heidelberg University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Cornelia von Hagens, Heidelberg University:

Primary Outcome Measures:
  • Menopausal complaints (MRS II) [ Time Frame: 12 and 24 weeks ]

Secondary Outcome Measures:
  • Cortisol profile (saliva) [ Time Frame: 12 and 24 weeks ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243607


Locations
Germany
Ambulanz für Naturheilkunde und Integrative Medizin
Heidelberg, Baden-Württemberg, Germany, D-69115
Sponsors and Collaborators
Heidelberg University
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

Responsible Party: Cornelia von Hagens, Head Complementary & Integrative Medicine, Dep. 4.2, Heidelberg University
ClinicalTrials.gov Identifier: NCT00243607     History of Changes
Other Study ID Numbers: HD175-05
First Submitted: October 21, 2005
First Posted: October 24, 2005
Last Update Posted: May 8, 2017
Last Verified: June 2009

Keywords provided by Cornelia von Hagens, Heidelberg University:
climacteric symptoms
breast cancer
hydrotherapy

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