Table 3.
Baseline (pre-treatment) |
One-month time pointa |
One-year time pointb |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
FACT/GOG-Ntx item | Ctx+ | Ctx− | α c | Significance | Ctx+ | Ctx− | α c | Significance | Ctx+ | Ctx− | α c | Significance |
Sensory symptoms | ||||||||||||
Numbness/tingling in hands | 0.32 (0.9) | 0.27 (0.7) | 0.050 | 0.986 | 1.4 (1.5) | 0.27 (0.8) | 0.003 | 0.002 | 1.3 (1.4) | 0.27 (0.9) | 0.008 | 0.001 |
Numbness/tingling in feet | 0.14 (0.5) | 0.41 (1.0) | 0.034 | 0.355 | 1.5 (1.6) | 0.09 (0.3) | 0.002 | 0.001 | 1.1 (1.4) | 0.41 (1.1) | 0.016 | 0.013 |
Discomfort in hands | 0.27 (0.9) | 0.32 (0.7) | 0.037 | 0.473 | 1.2 (1.5) | 0.32 (0.7) | 0.012 | 0.012 | 0.95 (1.2) | 0.55 (1.0) | 0.043 | 0.142 |
Discomfort in feet | 0.23 (0.5) | 0.50 (1.0) | 0.035 | 0.405 | 1.3 (1.5) | 0.59 (1.1) | 0.018 | 0.055 | 1.9 (1.3) | 1.1 (1.5) | 0.042 | 0.608 |
Motor symptoms | ||||||||||||
Joint pain or muscle cramps | 0.86 (1.1) | 0.91 (1.2) | 0.049 | 0.949 | 1.4 (1.4) | 1.3 (1.2) | 0.045 | 0.844 | 1.6 (1.3) | 1.6 (1.4) | 0.044 | 0.772 |
Feel weak all over | 0.41 (0.9) | 0.27 (0.6) | 0.045 | 0.860 | 1.6 (1.5) | 0.45 (0.7) | 0.005 | 0.003 | 1.0 (1.1) | 0.4 (0.9) | 0.016 | 0.021 |
Trouble walking | 0.27 (0.6) | 0.36 (0.5) | 0.030 | 0.277 | 0.68 (1.0) | 0.68 (0.7) | 0.040 | 0.550 | 0.67 (1.0) | 0.9 (0.9) | 0.031 | 0.296 |
Auditory symptoms | ||||||||||||
Trouble hearing | 0.41 (1.1) | 0.55 (0.7) | 0.024 | 0.152 | 0.59 (1.2) | 0.59 (0.7) | 0.032 | 0.338 | 0.55 (1.2) | 1.0 (1.0) | 0.019 | 0.071 |
Ringing/buzzing in ears | 0.23 (0.8) | 0.00 (0.0) | 0.027 | 0.153 | 0.59 (1.0) | 0.05 (0.2) | 0.010 | 0.009 | 0.55 (0.9) | 0.05 (0.2) | 0.014 | 0.018 |
Functional symptoms | ||||||||||||
Trouble buttoning buttons | 0.23 (0.8) | 0.00 (0.0) | 0.026 | 0.153 | 0.55 (1.1) | 0.00 (0.0) | 0.006 | 0.004 | 0.55 (0.9) | 0.00 (0.0) | 0.004 | 0.002 |
Trouble feeling the shape of small objects in hand | 0.32 (1.0) | 0.32 (0.7) | 0.034 | 0.352 | 0.64 (0.7) | 0.41 (0.7) | 0.022 | 0.141 | 0.45 (0.7) | 0.55 (1.1) | 0.048 | 0.895 |
Total scores | ||||||||||||
Sensory domain | 0.95 (2.4) | 1.5 (2.9) | 0.042 | 0.656 | 5.4 (5.6) | 1.3 (1.8) | 0.005 | 0.006 | 4.8 (3.9) | 2.3 (3.1) | 0.015 | 0.021 |
Motor domain | 1.6 (2.7) | 1.5 (1.8) | 0.041 | 0.575 | 3.6 (3.0) | 2.1 (1.9) | 0.019 | 0.110 | 3.1 (2.8) | 2.5 (2.8) | 0.036 | 0.419 |
Hearing domain | 0.68 (1.5) | 0.91 (1.0) | 0.021 | 0.127 | 1.3 (1.9) | 1.3 (1.3) | 0.036 | 0.524 | 1.2 (1.8) | 1.8 (1.8) | 0.028 | 0.157 |
Functional domain | 0.45 (1.7) | 0.00 (0.0) | 0.025 | 0.153 | 1.1 (2.0) | 0.05 (0.2) | 0.009 | 0.007 | 1.1 (1.7) | 0.05 (0.2) | 0.006 | 0.004 |
Total FACT-GOG/Ntx score | 3.7 (6.8) | 3.9 (4.1) | 0.047 | 0.894 | 11.4 (10.3) | 4.7 (3.4) | 0.017 | 0.034 | 9.9 (8.3) | 6.7 (5.5) | 0.022 | 0.148 |
Note Values in italics are statistically-significant
The severity of CIPN-sx were expressed as mean (SD) FACT/GOG-Ntx scores. Differences between in the distributions of FACT/GOG-Ntx scores between Ctx+ and Ctx− at each time point were tested using Mann-Whitney U tests, (α=0.05). Differences between total FACT/GOG-Ntx scores were compared using independent samples t-tests
Ctx+ women with breast cancer treated with surgery and/or radiation and chemotherapy, Ctx− women with breast cancer treated with surgery and/or radiation but no chemotherapy
One month following chemotherapy completion or yoked interval for Ctx−
One year following one-month time point.
Values represent Benjamin-Hochberg corrected alpha (α) levels used to reduce the risk of a type I error during multiple comparisons