Effectiveness of botox injections in the pectoral muscles for treatment of upper limb dysfunctions after breast cancer treatment

Phase 1

• Conditions: The aim of this study is to examine the effect of Botolinum Toxine infiltration in the pectoral muscle, in combination with an individual physical therapy programme, on pain and upper limb dysfunctions in women after breast cancer; MedDRA version: 17.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-005114-33-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-27
• Study Completion: 2020-01-01
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

- women after breast cancer with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor
- adjuvant chemotherapy and/or radiotherapy finished for at least 3 months
- Pain at the breast region for at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with metastasis and patients who cannot participate during the entire study or patients who are mentally or physically not able to participate in the study are excluded
- Cases were no injection is possible in the pectoral muscle (e.g. reconstruction with a tissue expander) are excluded as well.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified