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.

NCT04669119 | Unknown Phase 4

• 1 other identifier: 2020/6422
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Pain, Postoperative

Keywords

Dietary Supplements; Breast Cancer; Postoperative pain; Postoperative edema; Postoperative collections

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins

EXPERIMENTAL

Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins

Dietary Supplement: Bromelain/Boswellia Serrata Casperome; Dietary Supplement: Centella Asiatica/Vitamins

Bromelain/Boswellia Serrata Casperome and placebo

EXPERIMENTAL

Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo

Dietary Supplement: Bromelain/Boswellia Serrata Casperome; Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

Patients treated post-operatively for 30 days with placebo

Dietary Supplement: Placebo

Interventions

Bromelain/Boswellia Serrata Casperome DIETARY_SUPPLEMENT

Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton

Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins; Bromelain/Boswellia Serrata Casperome and placebo

Centella Asiatica/Vitamins DIETARY_SUPPLEMENT

Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton

Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins

Placebo DIETARY_SUPPLEMENT

Placebo

Bromelain/Boswellia Serrata Casperome and placebo; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years) with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy

You may not qualify if:

• Diabetical neuropathy
• Previous breast/chest surgery
• Allergies to studied drugs
• Severe kidney failure
• Alcohol and toxics addiction
• Axillary lymphadenectomy

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, 70124, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Interventions

Bromelains; Centella asiatica extract; Vitamins

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 16, 2020
• Study Start: December 31, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)