Center for Cognitive Medicine, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, 1601 23rd Ave. South, Nashville, TN, 37212, USA.
Department of Medicine, Vanderbilt University Medical Center/Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
J Cancer Surviv. 2019 Oct;13(5):673-686. doi: 10.1007/s11764-019-00786-6. Epub 2019 Jul 23.
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.
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.
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.
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.
The study was registered with clinicaltrials.gov (trial registration: NCT02312943).
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.
癌症治疗后常出现持续性化疗相关认知障碍(pCRCI),并降低生活质量;但目前尚无针对 pCRCI 的药物治疗方法。本研究初步探讨了经皮尼古丁贴片作为治疗 pCRCI 的策略,用于(1)降低主观认知主诉和(2)提高有 pCRCI 的乳腺癌、结肠癌、淋巴瘤或卵巢癌幸存者的客观认知表现。
参与者随机分为安慰剂(n = 11)或经皮尼古丁贴片(n = 11)组,治疗 6 周,随后停药 2 周,共 8 周。在治疗前、治疗中和治疗后,通过主观和客观认知功能测量对参与者进行评估。
在研究过程中,两组参与者的自我报告认知主诉严重程度均显著改善,采用癌症治疗功能评估-认知功能问卷(Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairments)测量。此外,两组的客观认知表现均有改善,但两组间的改善无显著差异。
由于安慰剂反应较大,我们无法确定是否存在药物效应。然而,我们确实观察到自我报告的认知症状有明显改善,这可能是由于参与试验的因素,而不是特定药物治疗的影响。
本研究在 clinicaltrials.gov 上注册(试验注册号:NCT02312943)。
这些结果表明,pCRCI 女性可以在短时间内主观认知得到改善,需要关注症状并密切随访。