Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms and adherence to self-treatment for 12 weeks.

Official Title
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Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy

Conditions
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Amenorrhea, Hot Flashes

Intervention / Treatment
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* Other: hydrotherapy according to Kneipp rules


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate treatment group (SBG)<br>immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG) | Other: hydrotherapy according to Kneipp rules<br>* 2-5 applications of hydrotherapy according to Kneipp rules (self application) per day<br>|
| No Intervention: waiting group (WG)<br>start of hydrotherapy (self treatment) after waiting period of 12 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal complaints (MRS II) |  | 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol profile (saliva) |  | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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climacteric symptoms, breast cancer, hydrotherapy