Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
18 Years
N/A
Female
Amenorrhea, Hot Flashes
Trial Information
Prospective Randomized Feasibility Study on the Self Application of Hydrotherapy to Treat Menopausal Symptoms Caused by Breast Cancer Therapy
Patients should use 2-5 different treatment options per day and fulfill a diary for symptoms
and adherence to self-treatment for 12 weeks.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Menopausal complaints (MRS II)
Outcome Time Frame:
12 and 24 weeks
Safety Issue:
No
Principal Investigator
Bernhard Uehleke, Dr.med. Dr.rer.nat. (PhD)
Investigator Role:
Study Chair
Investigator Affiliation:
Abt. für Naturheilkunde, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Immanual-Krankenhaus
Authority:
Germany: Ethics Commission
Study ID:
HD175-05
NCT ID:
NCT00243607
Start Date:
May 2006
Completion Date:
October 2008
Related Keywords:
- Amenorrhea
- Hot Flashes
- climacteric symptoms
- breast cancer
- hydrotherapy
- Amenorrhea
- Breast Neoplasms
- Hot Flashes
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