Trial Outcomes & Findings for Chemotherapy Induced Peripheral Neuropathy. Could Physical Therapy Help Treat Symptoms? (NCT NCT02239601)
NCT ID: NCT02239601
Last Updated: 2019-10-09
Results Overview
Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)
COMPLETED
NA
61 participants
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.
2019-10-09
Participant Flow
Participant milestones
| Measure |
Physical Therapy
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
treatment as usual
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Physical Therapy
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
treatment as usual
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Protocol Violation
|
4
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
treatment per usual
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=48 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=22 Participants
|
25 Participants
n=26 Participants
|
46 Participants
n=48 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=22 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=22 Participants
|
26 Participants
n=26 Participants
|
48 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=22 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)
Outcome measures
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale
Percentage of Participants with Pain (1-10)
|
30 percentage of participants
|
49 percentage of participants
|
|
Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale
Percentage of Participants with no pain (0)
|
70 percentage of participants
|
51 percentage of participants
|
PRIMARY outcome
Timeframe: 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 pointsA 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: \[average response (sum of responses divided by number of responses) -1\] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb
Outcome measures
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Disability of the Arm, Shoulder and Hand (DASH)
|
34 units on a scale
Interval 31.0 to 45.0
|
42 units on a scale
Interval 33.0 to 52.0
|
PRIMARY outcome
Timeframe: 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 pointsa 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.
Outcome measures
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).
Percentage of Patients with Neuropathic visits
|
16.1 percentage of patients
|
26 percentage of patients
|
|
Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).
Percentage of patients with non-neuropathic visits
|
83.9 percentage of patients
|
74 percentage of patients
|
SECONDARY outcome
Timeframe: 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 pointsVibration analysis testing for perception thresholds are specific to Aβ nerve fibres. The TSAII Vibration Sensory Analyzer (VSA): Medoc, Israel, was used. The pulp of the index finger lightly touches the sensor that delivers random and varying vibration amplitudes (µm). The participant responds "yes/no" to sensing the vibration. Vibration perception was selected for its sensitivity and has been suggested to be the first clinical sign of CIPN symptoms and was tested bilaterally. Low score indicates better perception while a higher score is poorer sensation. Perception score reported in micrometers (up to 4cm)
Outcome measures
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Vibration Sensory Analysis
Left Hand
|
0.23 micrometers (µm)
Interval 0.14 to 0.41
|
0.14 micrometers (µm)
Interval 0.04 to 0.31
|
|
Vibration Sensory Analysis
Right Hand
|
0.23 micrometers (µm)
Interval 0.14 to 0.41
|
0.23 micrometers (µm)
Interval 0.14 to 0.41
|
SECONDARY outcome
Timeframe: 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 pointsPressure Algometry (Somedic AB, Sweden) measured pressure/pain thresholds. A hand-held device applied perpendicular to the muscles being tested. Increasing pressure is applied until the participant determines that the sensation has changed from a feeling of pressure to a feeling of pain and force (Kpa) is recorded. When tested at a distant site from the source of pain this test measures central sensitization. Lower pressure values (more sensitive to noxious stimuli) suggest impaired central pain and/or diminished descending inhibition pathway. The left quadriceps muscle was tested as a measure of central sensitization.
Outcome measures
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Pain Pressure Thresholds
|
923 kpa
Standard Deviation 383
|
744 kpa
Standard Deviation 285
|
SECONDARY outcome
Timeframe: 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 pointsHand Dynamometry records grip strength in kgs and was used as a measure of function (3 trials). The dominant hand was tested using the Jamar dynamometer (Patterson medical, USA) in the 2nd handle position. All 48 participants were right handed.
Outcome measures
| Measure |
Physical Therapy
n=22 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=26 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Grip Strength
|
27.2 kgs
Standard Deviation 5.53
|
21.8 kgs
Standard Deviation 4.26
|
POST_HOC outcome
Timeframe: 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 pointsMeasuring Activity Participants were asked about their level of exercise per week at each assessment visit. Participants were considered active if they reported engaging in any form of moderate activity at least 4 times a week (consistent with recommended physical activity guidelines beyond activities of daily living such as walking to the bus or walking the dog around the block) at least 4 times per week on at least 3 out of 4 reassessment visits. Types of reported activities included cycling, running, yoga, swimming, Zumba, dance classes, and tennis. Walking was included if it was at least 30 minutes at a moderate pace. This sub-analysis re-defined the groups as 'active' and 'less active' for the comparison of vibration QST data. This was done to observe the possible impact of exercise on sensory preservation
Outcome measures
| Measure |
Physical Therapy
n=15 Participants
4 Physical therapy treatment sessions provided prior to chemotherapy and a home program to continue throughout the trial.
Physical Therapy: Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program will be provided to continue throughout chemotherapy treatment
|
Control
n=33 Participants
chemotherapy as usual without physical therapy
|
|---|---|---|
|
Vibration Sensory Outcome Stratified by Patient Activity Level
Vibration Left Hand
|
0.08 micrometers (µm)
Interval 0.04 to 0.14
|
0.23 micrometers (µm)
Interval 0.13 to 0.42
|
|
Vibration Sensory Outcome Stratified by Patient Activity Level
Vibration Right Hand
|
0.14 micrometers (µm)
Interval 0.04 to 0.23
|
0.24 micrometers (µm)
Interval 0.14 to 0.49
|
Adverse Events
Physical Therapy
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place