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.
Primary Purpose
Breast Cancer Female, Pain, Postoperative
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Bromelain/Boswellia Serrata Casperome
Centella Asiatica/Vitamins
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring Dietary Supplements, Breast Cancer, Postoperative pain, Postoperative edema, Postoperative collections
Eligibility Criteria
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
Sites / Locations
- Azienda Ospedaliero Universitaria Consorziale Policlinico di BariRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Bromelain/Boswellia Serrata Casperome and placebo
Placebo
Arm Description
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
Patients treated post-operatively for 30 days with placebo
Outcomes
Primary Outcome Measures
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
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
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
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)
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)
Full Information
NCT ID
NCT04669119
First Posted
December 1, 2020
Last Updated
December 14, 2020
Sponsor
University of Bari Aldo Moro
1. Study Identification
Unique Protocol Identification Number
NCT04669119
Brief Title
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.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bari Aldo Moro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Pain, Postoperative
Keywords
Dietary Supplements, Breast Cancer, Postoperative pain, Postoperative edema, Postoperative collections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Arm Type
Experimental
Arm Description
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
Arm Title
Bromelain/Boswellia Serrata Casperome and placebo
Arm Type
Experimental
Arm Description
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated post-operatively for 30 days with placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Bromelain/Boswellia Serrata Casperome
Intervention Description
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Intervention Type
Dietary Supplement
Intervention Name(s)
Centella Asiatica/Vitamins
Intervention Description
Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
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
Description
Ultrasound measured postoperative collections of breast and subcutaneous tissue after quadrantectomy with or without sentinel lymph node biopsy
Time Frame
30 days
Title
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
Description
VAS (visual analogue scale) from 0 (absence of pain) to 10 (worst pain)
Time Frame
30 days
Title
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
Description
DN4 (Douleur Neuropathique en 4 Questions) from 0 (low probability of neuropathic pain) to 10 (high probability of neuropathic pain)
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Gurrado, Prof
Phone
00390805595092
Email
ruggierodimonte@yahoo.it
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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