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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00243607
Enrollment
45
Registered
2005-10-24
Start date
2006-05-31
Completion date
2008-10-31
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea, Hot Flashes

Keywords

climacteric symptoms, breast cancer, hydrotherapy

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.

Interventions

OTHERhydrotherapy according to Kneipp rules

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

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Menopausal complaints (MRS II)12 and 24 weeks

Secondary

MeasureTime frame
Cortisol profile (saliva)12 and 24 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026