Jennifer N Vega1, Kimberly M Albert2, Ingrid A Mayer3, Warren D Taylor2,4, Paul A Newhouse2,4. 1. Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA. Jennifer.n.vega.1@vumc.org. 2. Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA. 3. Department of Medicine, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. 4. Geriatric Research, Education, and Clinical Center, Veterans Affairs Tennessee Valley Health System, Nashville, TN, USA.
Abstract
PURPOSE: Persistent chemotherapy-related cognitive impairment (pCRCI) is commonly reported following cancer treatment and negatively affects quality of life; however, there is currently no pharmacological treatment indicated for pCRCI. This pilot study obtained preliminary data regarding the use of transdermal nicotine patches as a therapeutic strategy for women with pCRCI to (1) reduce subjective cognitive complaints and (2) enhance objective cognitive performance in breast, colon, lymphoma, or ovarian cancer survivors with pCRCI. METHODS: Participants were randomized to either placebo (n = 11) or transdermal nicotine (n = 11) for 6 weeks, followed by 2 weeks of treatment withdrawal for a total of 8 weeks. Participants were assessed using both subjective and objective measures of cognitive functioning at five visits before, during, and after treatment. RESULTS: Over the course of the study, women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm. Additionally, objective cognitive performance measures improved in both groups; however, there was no significant difference in improvement between groups. CONCLUSIONS: Due to a large placebo response, we were unable to determine if a drug effect was present. However, we did observe substantial improvement in self-reported cognitive symptoms, likely resulting from factors related to participation in the trial rather than specific drug treatment effects. TRIAL REGISTRATION: The study was registered with clinicaltrials.gov (trial registration: NCT02312943). IMPLICATIONS FOR CANCER SURVIVORS: These results suggest that women with pCRCI can exhibit improvement in subjective cognition, with attention paid to symptoms and close follow-up over a short period of time.
RCT Entities:
PURPOSE: Persistent chemotherapy-related cognitive impairment (pCRCI) is commonly reported following cancer treatment and negatively affects quality of life; however, there is currently no pharmacological treatment indicated for pCRCI. This pilot study obtained preliminary data regarding the use of transdermal nicotine patches as a therapeutic strategy for women with pCRCI to (1) reduce subjective cognitive complaints and (2) enhance objective cognitive performance in breast, colon, lymphoma, or ovarian cancer survivors with pCRCI. METHODS:Participants were randomized to either placebo (n = 11) or transdermal nicotine (n = 11) for 6 weeks, followed by 2 weeks of treatment withdrawal for a total of 8 weeks. Participants were assessed using both subjective and objective measures of cognitive functioning at five visits before, during, and after treatment. RESULTS: Over the course of the study, women in both groups improved substantially in severity of self-reported cognitive complaints measured by Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments regardless of treatment arm. Additionally, objective cognitive performance measures improved in both groups; however, there was no significant difference in improvement between groups. CONCLUSIONS: Due to a large placebo response, we were unable to determine if a drug effect was present. However, we did observe substantial improvement in self-reported cognitive symptoms, likely resulting from factors related to participation in the trial rather than specific drug treatment effects. TRIAL REGISTRATION: The study was registered with clinicaltrials.gov (trial registration: NCT02312943). IMPLICATIONS FOR CANCER SURVIVORS: These results suggest that women with pCRCI can exhibit improvement in subjective cognition, with attention paid to symptoms and close follow-up over a short period of time.
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Authors: Tim A Ahles; Irene Orlow; Elizabeth Schofield; Yuelin Li; Elizabeth Ryan; James C Root; Sunita K Patel; Katrazyna McNeal; Alexandra Gaynor; Heidi Tan; Vani Katheria; Jessica Vazquez; Sergio Corrales-Guerrero; Keimya Sadeghi; Tiffany Traina; Arti Hurria Journal: J Cancer Surviv Date: 2022-10-24 Impact factor: 4.062
Authors: Jennifer N Vega; Kimberly M Albert; Ingrid A Mayer; Warren D Taylor; Paul A Newhouse Journal: J Cancer Surviv Date: 2021-05-11 Impact factor: 4.062