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Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT00243607
Recruitment Status : Completed
First Posted : October 24, 2005
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Cornelia von Hagens, Heidelberg University

Brief Summary:

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 or disease Intervention/treatment Phase
Amenorrhea Hot Flashes Other: hydrotherapy according to Kneipp rules Not Applicable

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  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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

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 Posted: October 24, 2005    Key Record Dates
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