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


- candidate number21343
- NTR NumberNTR4944
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2015
- Secondary IDss57283 EC UZ Leuven
- Public TitleEffectiveness of Botulinum Toxin Infiltration for treatment of upper limb dysfunctions after treatment for breast cancer.
- Scientific TitleEffectiveness of Botulinum Toxin Infiltration for treatment of upper limb dysfunctions after treatment for breast cancer.
- ACRONYMBotox in breast cancer patients
- hypothesisBreast cancer patients with chronic pain at the breast region will have a greater decrease in pain after a botulinum toxin infiltration, an individual physical therapy programme and home exercise programme than patients who reveive a saline solution infiltration, an individual physcial therapy programme and home exercise programme.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Chronic pain at the breast region
- 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 tumour - adjuvant chemotherapy and/or radiotherapy finished for at least 3 months - Pain at the breast region for at least 3 months
- 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate1-okt-2016
- Target number of participants50
- Interventions- botulinum toxine (experimental group) /saline solution infiltration (control group) at baseline - at baseline start of 3 months of individual physical therapy programme (1x/week) (mobilisations, stretching, scar tissue massage, exercise therapy) - after individual 3 months home programme with mobilizing and stretching exercises
- Primary outcomeThe primary outcome is the evolution of pain at the breast region.
- Secondary outcome- Pain-pressure thresholds of the pectoral muscles and shoulder girdle muscles - Shoulder mobility - Shoulder function - Shoulder alignment - Quality of life
- Timepoints- 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)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES An De Groef
- CONTACT for SCIENTIFIC QUERIES An De Groef
- Sponsor/Initiator UZ Leuven
- Funding
(Source(s) of Monetary or Material Support)
University of Leuven
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-jan-2015 - 27-feb-2015


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