HBOT LYCA: Hyperbaric Oxygen Therapy to reduce Lymphoedema after Breast Cancer - an explorative clinical trial - HBOT LYCA

Danish Cancer Society Research Center0 个研究点目标入组 25 人开始时间: 2015年3月10日最近更新: 2020年7月20日

试验速览

暂无简介。

•Participants in LYCA EXERCISE with lymphoedema 12 months after surgery for breast cancer will be invited to participate. Lymphedema is present if a swelling of the arm on the operated side has persisted more than 4 weeks with a combined score of 2 points or more on NRS for symptoms, and a clinical exam reveals 2 or more of the following criteria to be present (i-iii are compared with the unaffected side):
•i. decreased visibility of subcutaneous veins on the ventral lower arm or dorsal hand
•ii. loss of normal contours in the region of the medial side of the elbow/distal end of the upper arm
•iii. thicker skin and subcutis on palpation
•iv. pitting oedema
•They must also be declared cancer free (before clinical mammography)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Completed chemotherapy and radiotherapy less than 4 weeks ago
•untreated severe heart failure detected during pre-examination for HBOT
•Undrained pneumothorax
•Unability to equalize pressure in the ears in spite of drain treatment by Ear- Nose- and Throat specialist.
•Intractable Claustrophobia non-responsive of standard pre-medication.

发起方

Danish Cancer Society Research Center