NCT04669119

Effects of Bromelain and Boswellia Serrata Casperome With Centella Asiatica and Vitamins on Edema, Paresthesia and Postoperative Pain After Quadrantectomy With or Without Sentinel Lymph Node Biopsy.

Effects of Bromelain and Boswellia Serrata Casperome With Centella Asiatica and Thiamine, Riboflavin, Pyridoxine, Vitamin D, Superoxide Dismutase on Edema, Paresthesia and Postoperative Pain After Quadrantectomy With or Without Sentinel Lymph Node Biopsy: Blinded Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Bari Aldo Moro · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer Female
• Pain, Postoperative

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bromelain/Boswellia Serrata Casperome	Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
DIETARY_SUPPLEMENT	Centella Asiatica/Vitamins	Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2020-12-31
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2020-12-16
• Last updated: 2020-12-16

Locations

1 site across 1 country: Italy