Breast Cancer FemalePhase 4NCT04669119
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.
A Phase 4 study testing Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins in people with Breast Cancer Female and Pain, Postoperative, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Pain, Postoperative
- What is being tested?
- Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 31 Dec 2020to 31 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years) with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy
Who cannot join
- Diabetical neuropathy
- Previous breast/chest surgery
- Allergies to studied drugs
- Severe kidney failure
- Alcohol and toxics addiction
- Axillary lymphadenectomy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
Angela Gurrado, Prof, 00390805595092, ruggierodimonte@yahoo.it
About this study
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
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
- Being tested
- Bromelain/Boswellia Serrata Casperome, Centella Asiatica/Vitamins, Placebo
- Keywords
- Dietary Supplements, Breast Cancer, Postoperative pain, Postoperative edema, Postoperative collections
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromelain/Boswellia Serrata CasperomeDietary supplement
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Centella Asiatica/VitaminsDietary supplement
Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Bromelain/Boswellia Serrata Casperome; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Patients treated post-operatively for 30 days with placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Ultrasound measured postoperative collections of breast and subcutaneous tissue after quadrantectomy with or without sentinel lymph node biopsy
Measured: 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
VAS (visual analogue scale) from 0 (absence of pain) to 10 (worst pain)
Measured: 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
DN4 (Douleur Neuropathique en 4 Questions) from 0 (low probability of neuropathic pain) to 10 (high probability of neuropathic pain)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start31 Dec 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Gurrado, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669119
- Sponsor's protocol ID
- 2020/6422
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sgaramella LI, Pasculli A, Moschetta M, Puntillo F, Dicillo P, Clemente L, Maruccia M, Mastropasqua MG, Piombino M, Resta N, Rubini G, Prete FP, Serio G, Stucci LS, Giudice G, Testini M, Gurrado A; BCU PoliBa Working Group. Randomized controlled trial of bromelain and alpha-lipoic acid in breast conservative surgery. Sci Rep. 2025 Feb 10;15(1):4899. doi: 10.1038/s41598-025-86651-2.
PubMed 39929877
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04669119
- Acronym / sponsor ID
- 2020/6422
- Conditions
- Breast Cancer Female, Pain, Postoperative
- Keywords
- Dietary Supplements, Breast Cancer, Postoperative pain, Postoperative edema, Postoperative collections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 31 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins | Experimental | Dietary Supplement: Bromelain/Boswellia Serrata Casperome, Dietary Supplement: Centella Asiatica/VitaminsPatients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins |
| Bromelain/Boswellia Serrata Casperome and placebo | Experimental | Dietary Supplement: Bromelain/Boswellia Serrata Casperome, Dietary Supplement: PlaceboPatients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients treated post-operatively for 30 days with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>18 years) with breast cancer undergoing quadrantectomy with or without sentinel lymph node biopsy
Key exclusion criteria (6 listed)
- Diabetical neuropathy
- Previous breast/chest surgery
- Allergies to studied drugs
- Severe kidney failure
- Alcohol and toxics addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromelain/Boswellia Serrata CasperomeDietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton | Dietary supplement | Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins, Bromelain/Boswellia Serrata Casperome and placebo |
| Centella Asiatica/VitaminsDietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton | Dietary supplement | Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins |
| PlaceboPlacebo | Dietary supplement | Bromelain/Boswellia Serrata Casperome and placebo, Placebo |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 39929877Sgaramella LI, Pasculli A, Moschetta M, Puntillo F, Dicillo P, Clemente L, Maruccia M, Mastropasqua MG, Piombino M, Resta N, Rubini G, Prete FP, Serio G, Stucci LS, Giudice G, Testini M, Gurrado A; BCU PoliBa Working Group. Randomized controlled trial of bromelain and alpha-lipoic acid in breast conservative surgery. Sci Rep. 2025 Feb 10;15(1):4899. doi: 10.1038/s41598-025-86651-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins in people with Breast Cancer Female and Pain, Postoperative, run by University of Bari Aldo Moro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.