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: 17.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: BOTOX
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botox
CAS Number: 93384-43-1
Current Sponsor code: s57283
Other descriptive name: BOT
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: Not applicable;Primary end point(s): - baseline (before the botulinum toxin or placebo infiltration) - 1 month (= short term effects of the infiltration) - 3 months (= after physical therapy programme) - 6 months (= after the home programme and end of the study) ;Timepoint(s) of evaluation of this end point: - baseline (before the botulinum toxin or placebo infiltration) - 1 month (= short term effects of the infiltration) - 3 months (= after physical therapy programme) - 6 months (= after the home programme and end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactNele Devoogdt
UZ Leuven
Outcome results
None listed