Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
36
12 weeks of at-home walking and resistance exercise.
12 weeks of implementing eating tips and tracking food.
University of Maryland Medical System
Baltimore, Maryland, United States
CIPN-20 sensory subscale
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time frame: Time point 2 (approximately 6 weeks), controlling for baseline value
CIPN-20 sensory subscale
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Sensory, motor, and autonomic symptoms of CIPN
CIPN-20 total score (Postma et al 2005). The score includes 20 questions, each rated 1-4, and the score ranges from 20-80 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
Sensory loss
Finger and toe tactile sensitivity using monofilaments
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Cold-induced pain
Finger cold sensitivity using thermode
Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Numbness and tingling
Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
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Time frame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline