Background/Objectives. Decades of research have failed to uncover effective approaches to prevent chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of neurotoxic chemotherapy. Increased interest in placebo response as a potentially under-recognized confounder in CIPN trials was recently sparked by the results of a multisite NCI-funded phase II-III CIPN prevention study of duloxetine, a promising serotonin–norepinephrine reuptake inhibitor that enhances pain-inhibitory mechanisms within the central nervous system. Study findings revealed high and nearly equivalent response rates in three randomized treatment groups—little to no CIPN was reported by 65.2%, 66.0%, and 68.0% of study participants who received duloxetine 30 mg, 60 mg, or placebo treatment, respectively. Methods. We performed a meta-analysis of placebo response rates from seven randomized, double-blinded, placebo-controlled trials conducted over the past 20 years and comprising 191 placebo participants that were specifically testing interventions for oxaliplatin- and paclitaxel-induced peripheral neuropathy and that serially collected patient responses on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-Induced Neuropathy questionnaire. Additionally, we sought to identify trial- and patient-specific factors that predicted higher placebo response rates from a participant-level pooled analysis. Results. The placebo response rate was 10.0% [95% CI: 5.8%, 16.6%] when response was defined more conservatively as patients reporting no neuropathy at all. When the placebo response was defined more broadly based on patients reporting no or a little neuropathy, the placebo response rate was higher (39.6% [95% CI: 27.4%, 53.2%]). Male participants, receipt of oxaliplatin, and a 2:1 randomization ratio favoring the intervention arm were individually associated with a higher placebo response. Conclusions. High placebo response rates can threaten scientific progress toward identifying effective treatments for cancer treatment-associated side effects, like CIPN. Careful attention to study design factors, participant eligibility, and patient and research staff expectations may help to minimize placebo response rates in future CIPN intervention studies.
Background: The association of tobacco use and poor health outcomes is well documented. When tobacco users are hospitalized, some temporarily refrain from tobacco use with the aid of nicotine replacement therapy (NRT). However, most are unable to sustain cessation postdischarge. Objective: Investigate whether smoking cessation rates are higher for patients prescribed NRT compared with patients with no NRT (nNRT), 2 months postdischarge. Methods: Participants aged 19–65 years, who smoked ≥1 cigarette/day, were enrolled. Participants were randomly assigned to receive NRT versus nNRT. The primary outcome was self-reported smoking cessation at 2 months. Secondary outcomes were smoking decline and progression in the Transtheoretical Model (TTM) of change. Results: The 2-month cessation rates in the NRT group were 53.8% compared with 57.1% in the nNRT group, p = .86. The NRT group had a 27.7% decline in tobacco use, compared with 8.33% in the nNRT group. Although at 2 months the findings were not statistically significant, they were clinically significant; both groups demonstrated progress toward positive behavior change. Implications for Nursing: Tobacco users should receive NRT on admission and discharge. Additional follow-up intervention strategies based on the TTM stage should be incorporated as a tool to aid cessation.