Veronica B Ajewole1,2, James E Cox1, Joshua T Swan3,4, Soumya G Chikermane5, Beverly Lamoth6, Tomona Iso7,8, Laura O Okolo9, Christen L Ford10, Amy M Schneider1,11, Eleanor C Hobaugh1, Kelty R Baker12. 1. Department of Pharmacy, Houston Methodist Hospital, Houston, TX, USA. 2. Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX, USA. 3. Department of Pharmacy, Houston Methodist, Houston, TX, USA. swan.joshua@gmail.com. 4. Departments of Surgery and Pharmacy in the Institute for Academic Medicine, Houston Methodist Research Institute, Houston, TX, USA. swan.joshua@gmail.com. 5. Department of Pharmaceutical Health Outcomes and Policy, University of Houston, Houston, TX, USA. 6. Outpatient Bone Marrow Transplant Services, Houston Methodist Hospital Cancer Center, Houston, TX, USA. 7. Department of Pharmacy, Houston Methodist, Houston, TX, USA. 8. Department of Pharmacy, Houston Methodist Research Institute, Houston, TX, USA. 9. Hematology Services, Houston Methodist Hospital Cancer Center, Houston, TX, USA. 10. Outpatient Infusion Services, Houston Methodist Hospital Cancer Center, Houston, TX, USA. 11. Department of Pharmacy, Moffitt Cancer Center, Tampa, FL, USA. 12. Department of Medicine, Houston Methodist Hospital, Houston, TX, USA.
Abstract
PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) may necessitate chemotherapy dose reduction, delay, or discontinuation. This pilot study tested feasibility of patient enrollment, CIPN screening, and data collection in cancer patients for a future clinical study that will assess the safety and efficacy of an intervention that may prevent CIPN. METHODS: This prospective, observational, single-center, pilot study included adults with newly diagnosed lymphoma or multiple myeloma receiving neurotoxic chemotherapy. Patients were enrolled between September 2016 and February 2017. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire was completed by patients at 3 time points: baseline, week 6, and week 12. The primary outcome was change in the neurotoxicity score between these time points. RESULTS: Of 33 patients approached for consent, 28 (85%) provided consent and were enrolled. The FACT/GOG-Ntx questionnaire was completed by 28 (100%) at baseline, 25 (89%) at week 6, and 24 (86%) at week 12. Average (standard deviation) neurotoxicity scores were 36.5 (6.6) at baseline, 34.0 (8.3) at week 6, and 30.6 (7.6) at week 12. Neurotoxicity scores changed from baseline by - 2.7 points (95% CI - 5.5 to 0.1; p = 0.061) at week 6 and - 6.0 points (95% CI - 5.6 to - 0.8; p = 0.012) at week 12. Clinically meaningful declines (decrease of > 10% from baseline) in neurotoxicity score were detected in 36% (9 of 25) at week 6 and in 67% (16 of 24) at week 12. CONCLUSION: Sixty-seven percent of patients experienced clinically significant CIPN within 12 weeks of starting chemotherapy. Feasibility metrics for enrollment, consent, CIPN assessment, and follow-up were met.
PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) may necessitate chemotherapy dose reduction, delay, or discontinuation. This pilot study tested feasibility of patient enrollment, CIPN screening, and data collection in cancerpatients for a future clinical study that will assess the safety and efficacy of an intervention that may prevent CIPN. METHODS: This prospective, observational, single-center, pilot study included adults with newly diagnosed lymphoma or multiple myeloma receiving neurotoxic chemotherapy. Patients were enrolled between September 2016 and February 2017. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire was completed by patients at 3 time points: baseline, week 6, and week 12. The primary outcome was change in the neurotoxicity score between these time points. RESULTS: Of 33 patients approached for consent, 28 (85%) provided consent and were enrolled. The FACT/GOG-Ntx questionnaire was completed by 28 (100%) at baseline, 25 (89%) at week 6, and 24 (86%) at week 12. Average (standard deviation) neurotoxicity scores were 36.5 (6.6) at baseline, 34.0 (8.3) at week 6, and 30.6 (7.6) at week 12. Neurotoxicity scores changed from baseline by - 2.7 points (95% CI - 5.5 to 0.1; p = 0.061) at week 6 and - 6.0 points (95% CI - 5.6 to - 0.8; p = 0.012) at week 12. Clinically meaningful declines (decrease of > 10% from baseline) in neurotoxicity score were detected in 36% (9 of 25) at week 6 and in 67% (16 of 24) at week 12. CONCLUSION: Sixty-seven percent of patients experienced clinically significant CIPN within 12 weeks of starting chemotherapy. Feasibility metrics for enrollment, consent, CIPN assessment, and follow-up were met.
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