- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243607
Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baden-Württemberg
-
Heidelberg, Baden-Württemberg, Germany, D-69115
- Ambulanz für Naturheilkunde und Integrative Medizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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