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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02239601 |
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Date of registration:
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10/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms?
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Scientific title:
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Chemotherapy - Induced Peripheral Neuropathy (CIPN). Could There be a Role for Physical Therapy Treatment? |
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Date of first enrolment:
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December 1, 2014 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02239601 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Elizabeth R Hammond, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba |
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Name:
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Barbara L Shay, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed with stage I-III breast cancer undergoing regular docetaxel
treatment either docetaxel-cyclophosphamide (TC) or
5FU-epirubicin-cyclophosphamide-docetaxel (FEC-D).
- Patients that have not had chemotherapy in the past and do not have identified risk
factors (listed below in the exclusion criteria).
- All patients must be able to communicate in english or be able to have a translator
present at all appointments.
Exclusion Criteria:
- Patients diagnosed with stage IV breast cancer or who have co-morbid conditions that
are known to cause peripheral neuropathic symptoms, including previous chemotherapy,
exposure to toxins (such as lead), Diabetes, Shingles, B12 deficiency, Alcoholism,
Lyme disease, Syphilis, HIV, Hereditary disorders such as Charcot-Marie Tooth.
- Patients not planned to receive Docetaxel therapy.
- Patients who cannot communicate in English and unable to bring an interpreter will
also be excluded.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Peripheral Neuropathy, Secondary to Drugs or Chemicals
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Intervention(s)
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Other: Physical Therapy
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Primary Outcome(s)
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Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).
[Time Frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 3 months post-chemotherapy) and mixed models accounted for all time points]
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Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale
[Time Frame: Regression models of pain reported over time (mid-docetaxel chemotherapy- 6 months post-chemotherapy). Mid-chemotherapy time frame participants were re-assessed after the 2 round of TC and 4th round of FECD.]
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Disability of the Arm, Shoulder and Hand (DASH)
[Time Frame: administered on each re-assessment (pre-chemotherapy, mid-way through docetaxel chemotherapy, end of chemotherapy, 6 months post-chemotherapy) and mixed models accounted for all time points]
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Secondary Outcome(s)
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Grip Strength
[Time Frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points]
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Vibration Sensory Analysis
[Time Frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points]
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Pain Pressure Thresholds
[Time Frame: administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points]
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Secondary ID(s)
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H2014:281
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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