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.

Phase 4

• Conditions: Breast Cancer Female; Pain, Postoperative
• Interventions: Dietary Supplement: Bromelain/Boswellia Serrata Casperome; Dietary Supplement: Placebo; Dietary Supplement: Centella Asiatica/Vitamins

• Registration Number: NCT04669119
• Lead Sponsor: University of Bari Aldo Moro

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-14
• Last Update Submitted: 2020-12-14
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Study Start: 2020-12-31
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bromelain/Boswellia Serrata Casperome and placebo	Bromelain/Boswellia Serrata Casperome	Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
Placebo	Placebo	Patients treated post-operatively for 30 days with placebo
Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins	Bromelain/Boswellia Serrata Casperome	Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins	Centella Asiatica/Vitamins	Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Bromelain/Boswellia Serrata Casperome and placebo	Placebo	Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo

Primary Outcome Measures

Name	Time	Method
Change 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	30 days	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

Secondary Outcome Measures

Name	Time	Method
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	30 days	Ultrasound measured postoperative collections of breast and subcutaneous tissue after quadrantectomy with or without sentinel lymph node biopsy
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	30 days	VAS (visual analogue scale) from 0 (absence of pain) to 10 (worst pain)
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	30 days	DN4 (Douleur Neuropathique en 4 Questions) from 0 (low probability of neuropathic pain) to 10 (high probability of neuropathic pain)

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, Italy