N/A
N=61
Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms?
Breast Cancer · Peripheral Neuropathy, Secondary to Drugs or Chemicals
Bottom Line
View on ClinicalTrials.gov: NCT02239601 ↗Enrolled (actual)
61
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale — 30; 49; 70; 51 percentage of participants — p=0.053
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CancerCare Manitoba
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale |
30; 49; 70; 51 | 0.053 |
| PRIMARY Disability of the Arm, Shoulder and Hand (DASH) |
34; 42 | — |
| PRIMARY Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS). |
83.9; 74; 16.1; 26 | — |
| SECONDARY Vibration Sensory Analysis |
0.23; 0.14; 0.23; 0.23 | — |
| SECONDARY Pain Pressure Thresholds |
923; 744 | — |
| SECONDARY Grip Strength |
27.2; 21.8 | — |
Summary
The cause of Chemotherapy-Induced Peripheral Neuropathy (CIPN) is still unknown. An estimated 55-60% of patients will experience lasting symptoms affecting function for years post-treatment. Physical therapy is an established, effective treatment for entrapped nerves and neuropathic pain. This study sought to identify additional risk factors and provide evidence for the role of physical therapy in the treatment of CIPN.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02239601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.