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.

University of Bari Aldo Moro

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer Female; Pain, Postoperative

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04669119

2020/6422

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Bromelain/Boswellia Serrata Casperome and Centella Asiatica/Vitamins

Experimental group

Description:

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

Treatment:

Dietary Supplement: Centella Asiatica/Vitamins

Dietary Supplement: Bromelain/Boswellia Serrata Casperome

Bromelain/Boswellia Serrata Casperome and placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Bromelain/Boswellia Serrata Casperome

Placebo

Placebo Comparator group

Description:

Patients treated post-operatively for 30 days with placebo

Treatment:

Dietary Supplement: Placebo