Aim: to investigate the effects of dietary supplements on postoperative edema and pain in patients undergoing quadrantectomy for breast cancer. Methods: 120 patients will be randomized into 3 groups: A, treated with Bromelain/Boswellia Serrata Casperome and Centella Asiatica with Vitamins for 30 days; B, treated with Bromelain/Bosswellia Serrata and placebo for 30 days; C, treated with 2 placebos. Inclusion criteria: adult (\>18 years) patients with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy. Exclusion criteria: diabetic neuropathy, previous breast/chest surgeries, allergies to studied drugs, severe kidney failure, alcohol and toxics addiction, axillary lymphadenectomy. Patients will be studied through ultrasound examination for edema and collections, VAS and DN4 for pain, during 30 postoperative days. Patients will also be studied through psychological and physiatric evaluations. Wilcoxon, T student, Chi-Squared tests will be used to evaluate the outcomes. STATA 14 (StataCorp LP, College Station, Tex, USA) will be used for the analysis. P\<0.05 will be statistically significant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
Placebo
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
RECRUITINGChange in postoperative normalized echogenicity of breast and subcutaneous tissue from the first to the 30th day after quadrantectomy with or without sentinel lymph node biopsy
Ultrasound measured postoperative edema, obtained through the evaluation of normalized echogenicity, of breast and subcutaneous tissue after quadrantectomy with or without sentinel lymph node biopsy
Time frame: 30 days
Number of participants with postoperative fluid collections in the breast and or subcutaneous tissue during 30 days after quadrantectomy with or without sentinel lymph node biopsy
Ultrasound measured postoperative collections of breast and subcutaneous tissue after quadrantectomy with or without sentinel lymph node biopsy
Time frame: 30 days
Change in postoperative pain measured daily through VAS (visual analogue scale) from the first to the 30th day after quadrantectomy with or without sentinel lymph node biopsy
VAS (visual analogue scale) from 0 (absence of pain) to 10 (worst pain)
Time frame: 30 days
Change in postoperative probability of neuropathic pain measured daily through DN4 (Douleur Neuropathique en 4 Questions) from the first to the 30th day after quadrantectomy with or without sentinel lymph node biopsy
DN4 (Douleur Neuropathique en 4 Questions) from 0 (low probability of neuropathic pain) to 10 (high probability of neuropathic pain)
Time frame: 30 days
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