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Clinical Trials/EUCTR2014-005114-33-BE
EUCTR2014-005114-33-BE
Active, Not Recruiting
Phase 1

Effectiveness of Botulinum Toxin Infiltration for treatment of upper limb dysfunctions after treatment for breast cancer

Z Leuven0 sites50 target enrollmentJanuary 27, 2015
DrugsBOTOX

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Z Leuven
Enrollment
50
Status
Active, Not Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2015
End Date
January 1, 2020
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Z Leuven

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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