Back to resultsHydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors
Primary Purpose
Amenorrhea, Hot Flashes
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
hydrotherapy according to Kneipp rules
Sponsored by
About this trial
This is an interventional treatment trial for Amenorrhea focused on measuring climacteric symptoms, breast cancer, hydrotherapy
Eligibility 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)
Sites / Locations
- Ambulanz für Naturheilkunde und Integrative Medizin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
immediate treatment group (SBG)
waiting group (WG)
Arm Description
immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)
start of hydrotherapy (self treatment) after waiting period of 12 weeks
Outcomes
Primary Outcome Measures
Menopausal complaints (MRS II)
Secondary Outcome Measures
Cortisol profile (saliva)
Full Information
NCT ID
NCT00243607
First Posted
October 21, 2005
Last Updated
May 3, 2017
Sponsor
Heidelberg University
Collaborators
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00243607
Brief Title
Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors
Official Title
Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea, Hot Flashes
Keywords
climacteric symptoms, breast cancer, hydrotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immediate treatment group (SBG)
Arm Type
Experimental
Arm Description
immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)
Arm Title
waiting group (WG)
Arm Type
No Intervention
Arm Description
start of hydrotherapy (self treatment) after waiting period of 12 weeks
Intervention Type
Other
Intervention Name(s)
hydrotherapy according to Kneipp rules
Intervention Description
2-5 applications of hydrotherapy according to Kneipp rules (self application) per day
Primary Outcome Measure Information:
Title
Menopausal complaints (MRS II)
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Cortisol profile (saliva)
Time Frame
12 and 24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD)
Organizational Affiliation
Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus
Official's Role
Study Chair
Facility Information:
Facility Name
Ambulanz für Naturheilkunde und Integrative Medizin
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
D-69115
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors
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