Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bromelain/Boswellia Serrata Casperome | Dietary Supplement | — | UNRESOLVED |
| Centella Asiatica/Vitamins | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
- description
- Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
- interventionNames
- Dietary Supplement: Bromelain/Boswellia Serrata Casperome
- Dietary Supplement: Centella Asiatica/Vitamins
- type
- EXPERIMENTAL
- label
- Bromelain/Boswellia Serrata Casperome and placebo
- description
- Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
- interventionNames
- Dietary Supplement: Bromelain/Boswellia Serrata Casperome
- Dietary Supplement: Placebo
- type
- PLACEBO_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years) with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy Exclusion Criteria: * Diabetical neuropathy * Previous breast/chest surgery * Allergies to studied drugs * Severe kidney failure * Alcohol and toxics addiction * Axillary lymphadenectomy
References
Publications (1)
- DERIVEDSgaramella LI, Pasculli A, Moschetta M, Puntillo F, Dicillo P, Clemente L, Maruccia M, Mastropasqua MG, Piombino M, Resta N, Rubini G, Prete FP, Serio G, Stucci LS, Giudice G, Testini M, Gurrado A; BCU PoliBa Working Group. Randomized controlled trial of bromelain and alpha-lipoic acid in breast conservative surgery. Sci Rep. 2025 Feb 10;15(1):4899. doi: 10.1038/s41598-025-86651-2. PMID 39929877