HBOT LYCA: exploring if pressurechamber treatment can reduce lymphoedema after breast cancer
- Conditions
- breast cancer related lymphedemaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2015-000604-25-DK
- Lead Sponsor
- Danish Cancer Society Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 25
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
pregnancy
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method