Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-10-31

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.

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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.

Conditions

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Amenorrhea Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immediate treatment group (SBG)

immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)

Group Type EXPERIMENTAL

hydrotherapy according to Kneipp rules

Intervention Type OTHER

2-5 applications of hydrotherapy according to Kneipp rules (self application) per day

waiting group (WG)

start of hydrotherapy (self treatment) after waiting period of 12 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hydrotherapy according to Kneipp rules

2-5 applications of hydrotherapy according to Kneipp rules (self application) per day

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No