The journal of supportive oncology
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Randomized Controlled Trial
The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5).
Sleep disorders are a substantial problem for cancer survivors, with prevalence estimates ranging from 23% to 61%. Although numerous prescription hypnotics are available, few are approved for long-term use or have demonstrated benefit in this circumstance. Hypnotics may have unwanted side effects and are costly, and cancer survivors often wish to avoid prescription drugs. ⋯ This study failed to provide data to support the hypothesis that valerian, 450 mg, at bedtime could improve sleep as measured by the PSQI. However, exploratory analyses revealed improvement in some secondary outcomes, such as fatigue. Further research with valerian exploring physiologic effects in oncology symptom management may be warranted.
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Randomized Controlled Trial Multicenter Study
Fentanyl pectin nasal spray in breakthrough cancer pain.
Abstract Fentanyl pectin nasal spray (FPNS) is being developed to improve analgesic onset, treatment efficacy, and satisfaction/acceptability in treating breakthrough cancer pain (BTCP). Patients (n = 114) were entered into a randomized, placebo-controlled, double-blind, multicenter study. Patients who successfully titrated (n = 83) entered a double-blind phase; 10 episodes of BTCP were treated with the effective dose (7) or placebo (3). ⋯ Episode analysis (FPNS, n = 459; placebo, n = 200) revealed that compared with placebo, 33% of FPNS episodes showed an onset of improvement in pain intensity at 5 minutes (P < 0.05); 33% of episodes by 10 minutes had clinically meaningful pain relief (> or = 2 point decrease in pain intensity; P < 0.0001). Satisfaction with the convenience and ease of use of FPNS was reported by 70% and 68% of patients, respectively; 87% of patients elected to continue treatment post study. FPNS provided rapid analgesia in BTCP and was well accepted by patients.
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Randomized Controlled Trial
Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB.
Hot flashes are a complication of androgen deprivation therapy for prostate cancer. A phase III study showed that use of low-dose gabapentin was well tolerated and moderately decreased the frequency of hot flashes due to androgen deprivation therapy when taken for 4 weeks. The current study, an open-label continuation of the randomized study, examined the efficacy and toxicity of gabapentin when taken for (an additional) 8 weeks. ⋯ Men originally receiving the placebo or lowest dose of gabapentin (300 mg/d) had improved hot flash control relative to that at the end of the randomized phase. Minimal adverse effects were reported. These findings suggest that low-dose gabapentin is moderately efficacious for at least 12 weeks of hot flash treatment in men undergoing androgen deprivation therapy for prostate cancer and seems to be well tolerated. (NCT00028572)
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Referral criteria were developed to rationalize transfer-of-care requests and referrals to a hospital-based palliative care program (PCP) in Saudi Arabia. This study aimed to explore the impact of an approved referral criteria policy on the pattern of referrals to a PCP. Two periods, 19 months each, were identified: one before the implementation of the referral criteria (precriteria), and the other started 6 months later (post-criteria). ⋯ The median survival of referred patients decreased from 2.27 months during the precriteria period to 1.73 months during the postcriteria period (P = 0.0051). The findings suggest that the implementation of the referral criteria policy was associated with a more rational pattern of transfer-of-care referrals to the PCP. However, more educational efforts and organizational actions are needed to prevent delayed referrals of cancer patients to palliative care teams.