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Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

H

Heidelberg University

Status

Completed

Conditions

Amenorrhea
Hot Flashes

Treatments

Other: hydrotherapy according to Kneipp rules

Study type

Interventional

Funder types

Other

Identifiers

NCT00243607
HD175-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

immediate treatment group (SBG)
Experimental group
Description:
immediate start of hydrotherapy (self treatment) in immediate treatment group (SBG)
Treatment:
Other: hydrotherapy according to Kneipp rules
waiting group (WG)
No Intervention group
Description:
start of hydrotherapy (self treatment) after waiting period of 12 weeks

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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