the Effect of Therapeutic Mammoplasty on the Start of Adjuvant Chemotherapy

NCT05920070 | Completed

• 1 other identifier: tmp and adjuvant chemotherapy
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

the purpose of this study was to examine the impact of therapeutic mammoplasty on the delivery of adjuvant chemotherapy

Conditions

Effect of Therapeutic Mammoplasty on Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• assesing the complocation of therapeutic mammoplasty and whether it delays the start of adjuvant chemotherapy or not

  noting the date of the operation and whether or not it delays the start of adjuvant chemotherapy due to any complications

  about two months

Interventions

therapeutic mammoplasty PROCEDURE

therapeutic oncoplastic surgeries in cases of breast cancer

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: female patient underwent therapeutic mammoplasty
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

female patients between the age of 25 to 65 who underwent therapeutic ammoplasty and will recieve adjuvant chemotherapy

You may qualify if:

• Oncoplastic procedures were proposed for patients in whom breast conservative treatment is possible on oncologic grounds but in whose cases a standard resection without reconstruction would result in poor cosmesis with the following criteria:
• Female patients with ages ranging from 25 to 65 years
• Patients with early surgically treatable breast cancer (Stage I, II and IIIa)
• Patients whose management was by surgery followed by adjuvant chemotherapy.
• Patients with tumors in any quadrant of the breast
• Patients with large/ptotic breasts (especially with brassiere size C, D or DD).
• patients underwent therapeutic mammoplasty as primary ttt for breast cancer.

You may not qualify if:

• \) Patients with a contraindication to breast conservative surgery. 2) Patients with small sized breasts, which are not suitable for reduction (with brassiere size A or B).
• \) Patients who are not compliant; Non-compliant patients included those demanding mastectomy for fear of local recurrence, patients not consenting to the proposed procedure after adequate counseling, those refusing post-operative adjuvant Radiotherapy, refusal of a reduction mammoplasty of the contralateral breast as a symmetrizing procedure and patients who are not able to consent such as mentally challenged patients.
• \) patients who have received neoadjuvant chemotherapy. 5) patients underwent conventional breast conservative surgery . 6) patient underwent immediate reconstruction surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Harvey J, Henderson J, Patel L, Murphy J, Johnson R. Therapeutic mammaplasty - impact on the delivery of chemotherapy. Int J Surg. 2014;12(5):51-5. doi: 10.1016/j.ijsu.2013.10.013. Epub 2013 Nov 5.

  PMID: 24200754 RESULT

• Bamford R, Sutton R, McIntosh J. Therapeutic mammoplasty allows for clear surgical margins in large and multifocal tumours without delaying adjuvant therapy. Breast. 2015 Apr;24(2):171-4. doi: 10.1016/j.breast.2015.01.003. Epub 2015 Jan 24.

  PMID: 25623754 RESULT

• Khan J, Barrett S, Forte C, Stallard S, Weiler-Mithoff E, Doughty JC, Romics L Jr. Oncoplastic breast conservation does not lead to a delay in the commencement of adjuvant chemotherapy in breast cancer patients. Eur J Surg Oncol. 2013 Aug;39(8):887-91. doi: 10.1016/j.ejso.2013.05.005. Epub 2013 Jun 5.

  PMID: 23746877 RESULT

• 4. Simpson, Gregory, M. Chandrashekar, and S. Darn.

  RESULT

• Dogan L, Gulcelik MA, Karaman N, Ozaslan C, Reis E. Oncoplastic surgery in surgical treatment of breast cancer: is the timing of adjuvant treatment affected? Clin Breast Cancer. 2013 Jun;13(3):202-5. doi: 10.1016/j.clbc.2012.09.015. Epub 2012 Oct 26.

  PMID: 23103367 RESULT

• Klit A, Tvedskov TF, Kroman N, Elberg JJ, Ejlertsen B, Henriksen TF. Oncoplastic breast surgery does not delay the onset of adjuvant chemotherapy: a population-based study. Acta Oncol. 2017 May;56(5):719-723. doi: 10.1080/0284186X.2017.1281437. Epub 2017 Feb 6.

  PMID: 28162018 RESULT

• Kontos M, Lewis RS, Luchtenborg M, Holmberg L, Hamed H. Does immediate breast reconstruction using free flaps lead to delay in the administration of adjuvant chemotherapy for breast cancer? Eur J Surg Oncol. 2010 Aug;36(8):745-9. doi: 10.1016/j.ejso.2010.06.013.

  PMID: 20605080 RESULT

Study Officials

• abdelradi amdelsalam, proffessor

  Assiut University

  STUDY DIRECTOR

• mostapha thabet, professor

  Assiut University

  STUDY DIRECTOR

• negmeldeen abulnaga, assistant lecturer

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at general surgery department

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: March 1, 2015
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: about two years