The Effect of Octreotide on Wound Drainage After Mastectomy

NCT05682209 | Completed Phase 4

• 1 other identifier: UI/EC/20/0275
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who had mastectomy for breast cancer usually have drainage of some fluid from the site of surgery. This could be prolonged and may lead to other negative consequences after surgery. Octreotide could potentially reduce the amount of this drainage. In this study, patients were grouped into two: a first group that received octreotide injection and a second group that received a placebo. The study tested whether octreotide injection has any effect on the duration of fluid drainage from the surgery site after mastectomy for breast cancer.

Conditions

Seroma Following Procedure

Keywords

Mastectomy; Drainage duration; Octreotide; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Time to drain removal

  Time that elapsed from the day of surgery till the wound drain was removed

  24 hours after surgery till a drain output of <40ml in the preceding 24hours

Secondary Outcomes (1)

• Incidence of seroma

  From the first post-operative day till 28 days post-operatively

Study Arms (2)

Octreotide group

ACTIVE COMPARATOR

Received 100µg of octreotide intravenously 8-hourly for 5 days from the first post-operative day

Drug: Octreotide Injection

Control group

PLACEBO COMPARATOR

Received 1ml of sterile water intravenously 8-hourly for 5 days from the first post-operative day

Other: Sterile water

Interventions

Octreotide Injection DRUG

100µg of octreotide intravenously 8-hourly for 5 days from the first post-operative day

Also known as: Actide, Samarth, India

Octreotide group

Sterile water OTHER

1ml of sterile water intravenously 8-hourly for 5 days from the first post-operative day

Control group

Eligibility Criteria

• Gender Eligibility Details: Phenotypically female patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All female breast cancer patients requiring modified radical mastectomy

You may not qualify if:

• All mastectomies without axillary clearance (simple and toilet mastectomies)
• Breast-conserving surgeries
• Patients undergoing immediate breast reconstruction after mastectomy
• Previous axillary surgery

Sponsors & Collaborators

• Ikechukwu Bartholomew Ulasi: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, +234, Nigeria

Location

Related Publications (4)

• Michalik T, Matkowski R, Biecek P, Szynglarewicz B. The use of ultrasonic scalpel lowers the risk of post-mastectomy seroma formation in obese women. J Cancer. 2019 Jun 9;10(15):3481-3485. doi: 10.7150/jca.29774. eCollection 2019.

  PMID: 31293652 BACKGROUND

• van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.

  PMID: 21849243 BACKGROUND

• Carcoforo P, Soliani G, Maestroni U, Donini A, Inderbitzin D, Hui TT, Lefor A, Avital I, Navarra G. Octreotide in the treatment of lymphorrhea after axillary node dissection: a prospective randomized controlled trial. J Am Coll Surg. 2003 Mar;196(3):365-9. doi: 10.1016/S1072-7515(02)01757-X.

  PMID: 12648685 BACKGROUND

• Ogundiran TO, Ayandipo OO, Ademola AF, Adebamowo CA. Mastectomy for management of breast cancer in Ibadan, Nigeria. BMC Surg. 2013 Dec 19;13:59. doi: 10.1186/1471-2482-13-59.

  PMID: 24354443 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ikechukwu B. Ulasi

  University College Hospital, Ibadan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients scheduled for modified radical mastectomy (MRM) were randomized into a treatment group that received 100µg of octreotide and a control group that received 1ml of sterile water intravenously 8-hourly for 5 days from the first post-operative day

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 12, 2023
• Study Start: December 18, 2020
• Primary Completion: November 15, 2021
• Study Completion: December 2, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

NG (1)