Breast cancer Cancer Malignant neoplasm of the breast
Conditions
Interventions
Patients will be included in the study one month after termination of radiotherapy. At that time all other active cancer treatment will be finished, except for anti-hormone treatment with tamoxifen, l
Sponsors
Lund University Hospital (Sweden)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women (no age limit) with breast cancer 2. Treated with axillary dissection, mastectomy or segmental resection of the breast, and radiotherapy to the breast and axilla 3. All active cancer treatment is terminated, except for anti-hormone treatment with tamoxifen, letrozol, anastrozole, and exemestane 4. Able to understand the nature of the trial and give written informed consent
Exclusion criteria
Exclusion criteria: 1. Known sensitivity to pentoxifylline or vitamin E 2. Disorders related to muscles or joints 3. Corticosteroid treatment during radiotherapy treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder mobility is assessed by a goniometer; axillary movement will be analysed first time when all 80 patients have finished the first year of medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lymphoedema, assessed by measurement of water displacement 2. LENT-SOMA breast score, assessed every 3 months during the year of medication, twice in year 2 and yearly for 3 years up to 5 years 3. Impedance measurement of RIF areas 4. Plasma TGF-beta1 levels, analysed as a separate part of the study when patients have been included for 1 year Secondary endpoint will be analysed (blinded) after one year of medication. All patients will be followed for 5 years and the final analysis will be done when all patients have been followed for 5 years. | — |
Countries
Sweden
Outcome results
None listed