breast cancer related lymphedema
Conditions
Interventions
Trade Name: Conoxid 100%, Medicinsk Oxygen, Kryogen
Product Name: Medicinal Oxygen
Pharmaceutical Form: Medicinal gas, cryogenic
Sponsors
Danish Cancer Society Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We investigate if women who have developed lymphoedema 1 year after surgery for breast ancer benefit from Hyperbaric Oxygen Treatment (HBOT) in terms of reduction of the arm volume. ;Secondary Objective: To examine if HBOT can increase the lymphatic clearance rate measured by lymphoscintigraphy, as well as psychological and physical function.;Primary end point(s): arm volume (perometry) and presence of lymphoedema by definiton of clinical criteria (2 of 4 clinical criteria fulfilled);Timepoint(s) of evaluation of this end point: pre treatment day 1 mid treatment day 20 end treatment day 40 3 month follow-up 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): lymphatic clearance rate (lymphoscintigraphy) Bodycomposition and arm volume by Dual Energy X ray scan plasma Inflammatory biomarkers measured by blod samples (for biobank) Validated scales for physical and psychological function by self-report in questionnaires;Timepoint(s) of evaluation of this end point: pre treatment day 1 end treatment day 40 6 months follow-up | — |
Countries
Denmark
Contacts
Public ContactOle Hyldegaard
Rigshospitalet
Outcome results
None listed