A Phase 4 interventional study of Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins in Breast Cancer Female and Pain, Postoperative, sponsored by University of Bari Aldo Moro. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by University of Bari Aldo Moro · Phase 4, Interventional, and Treatment
Among 10 studies testing vitamins in Pain, Postoperative — 3 open to participants now, 4 under way, none of them phase 3. A drug class: Vitamins · Pain, Postoperative.
Among the 10 studies testing vitamins in Pain, Postoperative, this one is the 2nd largest by planned enrollment, is the only one that started in 2020, is one of 4 in phase 4, and was the 4th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
Browse Pain, Postoperative studies →3 of the 10 studies testing vitamins in Pain, Postoperative are open now, in 2 countries. Recruiting first, the newest first:
University Health Network, Toronto · Sites in Canada
Ages 18+
Benha University · Sites in Egypt
Ages 18–60 · Healthy volunteers
Cairo University · Sites in Egypt
Ages 18–65
By country, each count listing its studies:
A class of medicines: which ones, and the studies of each, are on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Median enrollment 58 across the 10 interventional studies. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
University of Bari Aldo Moro is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
University of Bari Aldo Moro has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
1 of the studies testing vitamins in Pain, Postoperative that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06123715University Health Network, TorontoPerioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty | 2026-12-31 |
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Among the 10 studies testing vitamins in Pain, Postoperative, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients treated post-operatively for 30 days with Bromelain/Boswellia Serrata Casperome and placebo
Dietary Supplement: Bromelain/Boswellia Serrata Casperome · Dietary Supplement: Placebo
Patients treated post-operatively for 30 days with placebo
Dietary Supplement: Placebo
Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
Drug pages: Centella asiatica · Vitamins
Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
Placebo
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
Time frame: 30 days
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
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
VAS (visual analogue scale) from 0 (absence of pain) to 10 (worst pain)
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
DN4 (Douleur Neuropathique en 4 Questions) from 0 (low probability of neuropathic pain) to 10 (high probability of neuropathic pain)
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2020; primary completion for Dec 2021, 12 months later.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 12 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Centella asiatica · Vitamins
University of Bari Aldo Moro