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.

December 14, 2020 updated by: Angela Gurrado, University of Bari Aldo Moro

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
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
Experimental: Bromelain/Boswellia Serrata Casperome and placebo
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
Dietary supplement: Placebo
Placebo
Dietary supplement: Bromelain/Boswellia Serrata Casperome
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Placebo Comparator: Placebo
Patients treated post-operatively for 30 days with placebo
Dietary supplement: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari Aldo Moro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 31, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/6422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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