E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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E.1.1.1 | Medical condition in easily understood language |
To examine the effect of botox infiltration in the pectoral muscle, in combination with an individual physical therapy programme, on pain and upper limb dysfunctions in women after breast cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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)
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E.5.1.1 | 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) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Start of the trial at 1th January 2015. Last inclusion at 1th January 2016. Follow-up period of 6 months. If the inclusion rate slows done we can extend the study for 6 monhts |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |