Who is sponsoring NCT04669119?

NCT04669119 is sponsored by University of Bari Aldo Moro.

What drugs are being tested in NCT04669119?

Interventions in NCT04669119: Bromelain/Boswellia Serrata Casperome, Centella Asiatica/Vitamins, Placebo.

What condition does NCT04669119 study?

NCT04669119 studies Breast Cancer Female, Pain, Postoperative.

Is NCT04669119 still recruiting?

NCT04669119 is currently status unknown. Last updated 16 December 2020.

Last reviewed 2020-12-16 · How we verify

NCT04669119

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Status unknown Phase 4 Last updated 16 December 2020

What this trial tests

Phase 4 trial testing Bromelain/Boswellia Serrata Casperome in Breast Cancer Female in 120 participants. Status unknown.

Timeline

31 December 2020

Primary endpoint
31 December 2021

31 January 2022

Quick facts

Lead sponsor	University of Bari Aldo Moro
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	31 December 2020
Primary completion	31 December 2021
Estimated completion	31 January 2022
Sites	1 location across Italy

Drugs / interventions tested

Bromelain/Boswellia Serrata Casperome
Centella Asiatica/Vitamins
Placebo

Conditions studied

Breast Cancer Female — all drugs for Breast Cancer Female →
Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

University of Bari Aldo Moro

Who can join

18 and older, female only, with Breast Cancer Female or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Agri-Food By-Products in Cancer: New Targets and Strategies.
Sorrentino C, Di Gisi M, Gentile G, Licitra F, et al · · 2022 · cited 12× · PMID 36428610 · DOI 10.3390/cancers14225517
Randomized controlled trial of bromelain and alpha-lipoic acid in breast conservative surgery.
Sgaramella LI, Pasculli A, Moschetta M, Puntillo F, et al · · 2025 · PMID 39929877 · DOI 10.1038/s41598-025-86651-2

Verify or expand the search:

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Other University of Bari Aldo Moro trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04669119 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Bari Aldo Moro
Last refreshed: 16 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04669119.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing