Clinical trial NCT03858153: Exercise and Nutrition Interventions During Chemotherapy K07
Official title: The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuropathy;Peripheral
Keywords: chemotherapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. 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.


Eligibility criteria: Inclusion criteria (subjects must...)

1. Be female
2. Have breast cancer
3. Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
4. Have at least six months life expectancy according to the patient's oncologist or designee
5. Be able to read English
6. Be at least 18 years old (no upper limit on age)
7. Provide written informed consent

Exclusion criteria (subjects must not...)

1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
2. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.

Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)

1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)

Primary outcomes:
measure: Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
timeFrame: Time point 2 (approximately 6 weeks), controlling for baseline value
Secondary outcomes:
measure: Sensory loss
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Numbness and tingling
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Sensory, motor, and autonomic symptoms of CIPN
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline
measure: Patient-reported sensory symptoms of CIPN
timeFrame: Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline
Other outcomes:
measure: Musculoskeletal function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Cardiovascular function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
measure: Neuropsychological function
timeFrame: Time point 2 (approx. 6 weeks), controlling for baseline
measure: Immunological function
timeFrame: Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
citation: Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.