Faria, C., Li, X., Nagl, N., & McBride, A. (2014). Outcomes associated with 5-HT3-RA therapy selection in patients with chemotherapy-induced nausea and vomiting: A retrospective claims analysis. American Health and Drug Benefits, 7, 50–58.
To evaluate the clinical and economic impact of delayed chemotherapy-induced nausea and vomiting (CINV) on patients who received initial and maintenance therapy with the 5-hydroxytryptamine 3 (5HT3) receptor antagonist palonosetron compared to older agents
There was no intervention in this retrospective study; however, the procedure was outlined. Using the OptumInsight® database, researchers evaluated the impact of 5HT3 on chemotherapy-naïve patients. This database provided information on all pharmacy and medical claims for each subject, and records were accessed six months prior to the initial chemotherapy treatment and six months after. Patients were not evaluated if the type of antiemetic changed or if chemotherapy was changed. ICD9 codes and pharmacy charges were monitored for primary or secondary diagnoses of nausea, vomiting, and dehydration. Economic outcomes also were evaluated and calculated.
Retrospective database analysis
No instruments were used, but information extracted from the database included patient and treatment characteristics, nausea, vomiting, Charlson Comorbidity Index scores, antiemetic therapy, and specific 5HT3 use.
Preindex comorbidity scores were lowest in the palonosetron group and highest in the dolasetron group. The overall rate for delayed CINV at cycle 1 was 15.6% for all groups. When compared to palonosetron, patients who received ondansetron (p < 0.002), granisetron (p < 0.001), and dolasetron (p = 0.002) had higher rates of CINV in the second and subsequent cycles of chemotherapy. Dexamethasone was consistently used in the first cycle for all treatment groups. Aprepitant was used most often in the palonosetron group (10.7%) compared to ondansetron (3.6%), granisetron (2.3%), and dolasetron (2.5%).
5HT3 agents were effective in preventing CINV. There were differences in 5HT3 efficacy and cost. Delayed CINV rates increased with subsequent cycles of older 5HT3 agents. Palonosetron showed improvement over time. Similar trends were seen with healthcare resource use.
This study demonstrated cost effectiveness. Medical costs constituted the largest costs. Costs were higher if a patient experienced CINV. Nurses need to use guidelines and risk factors when starting patients on chemotherapy. Using a 5HT3 agent based on the emetogenic potential of chemotherapy is important.
Fares, K.M., Mohamed, S.A., Abd El-Rahman, A.M., Mohamed, A.A., & Amin, A.T. (2015). Efficacy and safety of intraperitoneal dexmedetomidine with bupivacaine in laparoscopic colorectal cancer surgery, a randomized trial. Pain Medicine, 16, 1186–1194.
To investigate the safety and efficacy of intraperitoneal bupivacaine and dexmedetomidine in patients undergoing laparascopic colorectal surgery for postoperative pain management
Patients were randomized to one of three groups: (a) control (intraperitoneal injection of saline), (b) bupivacaine only (125 mg, 0.25%) injection, and (c) combined dexmedetomidine and bupivacaine (bupivacaine 0.25% and 1 mcg/kg dexmedetomidine). After hemostasis was achieved in surgery, intraperitoneal instillation of study drugs was sprayed uniformly into the periotoneal cavity guided by camera. Pain was assessed at baseline and at 2, 3, 6, 8, 12, and 24 hours postoperatively. IV tramadol (100 mg) was given when pain was at least 3 or upon patient request.
The group that received bupivacaine and dexmedetomidine had significantly lower pain at 2, 4, and 24 hours compared to the other study groups (p < 0.03) and needed rescue analgesic much later (p = 0.0002). No difference in time to analgesia existed between study groups 1 and 2. Average overall postoperative tramadol consumption was lower in the group receiving the combined intraperitoneal analgesia (p = 0.001).
Intraperitoneal administration of bupivacaine and dexmedetomidine improved the effectiveness and duration of postoperative analgesia compared to bupivacaine alone or placebo.
Findings showed that loco-regional analgesic administration after laparoscopic colorectal surgery was effective for postoperative analgesia, and the addition of dexmedetomidine to bupivacaine improved efficacy and duration of analgesic effect.
Fares, K.M., Mohamed, S.A., & Abdel-Ghaffar, H.S. (2014). High dose intrathecal morphine for major abdominal cancer surgery: A prospective double-blind, dose-finding clinical study. Pain Physician, 17, 255–264.
To investigate the safety and efficacy of three doses of intrathecal morphine in patients receiving major abdominal surgery
Patients were randomly assigned to receive 0.2 mg, 0.5 mg, or 1 mg of morphine injected into the L3-4 space prior to anesthesia. All patients received the same type of anesthesia and reversal. Vital signs and Visual Analog Scales for pain were assessed at six, 12, 18, 24, 36, 48, and 72 hours postoperatively. At patient request, or for a pain score greater than or equal to 3, rescue analgesia of 100 mg IV tramadol was given.
Double-blinded, randomized trial
The mean time in hours till the first analgesic request was longer in those receiving 0.5 mg (22.13, p < 0.001) and 1 mg (30.83 , p < 0.001) of morphine. Mean total tramadol consumption also was lower in these groups (p < 0.001) with the lowest consumption in those receiving 1 mg (p < 0.04). For the first 18 hours postoperatively, those receiving higher doses of intrathecal morphine had lower pain scores (p < 0.02) than those receiving 0.2 mg. At 24 hours and beyond, there were no significant differences in pain scores among groups. More patients in the higher dose groups developed pruritus (p = 0.01). There were no other significant differences in overall adverse effects between groups. One older patient in the 1 mg dose group developed respiratory depression.
Doses of 0.5 mg and 1 mg intrathecal morphine preoperatively resulted in longer postoperative pain control and less analgesic consumption with nonsignificant differences in adverse effects compared to a dose of 0.2 mg.
The provision of high-dose intrathecal morphine preoperatively resulted in improved postoperative pain control among patients receiving major abdominal surgeries for cancer. Higher doses were associated with better pain outcomes for the first 24–48 hours after surgery. The administration of high-dose intrathecal morphine necessitated careful patient selection and strict postoperative monitoring.
Fallon, M.T., Storey, D.J., Krishan, A., Weir, C.J., Mitchell, R., Fleetwood-Walker, S.M., . . . Colvin, L.A. (2015). Cancer treatment-related neuropathic pain: Proof of concept study with menthol—A TRPM8 agonist. Supportive Care in Cancer, 23, 2769–2777.
To evaluate whether a topical menthol product has clinical benefit for pain of peripheral neuropathy
Patients were given a 1% menthol in aqueous cream and were instructed how to apply it to the affected area and corresponding dermatome region of the spine twice daily. Patients were followed for four to six weeks.
PHASE OF CARE: Late effects and survivorship
Open-label
Eighty-two percent showed an improvement in pain scores (p < 0.001). Significant improvements were observed in some aspects of quantitative sensory testing for mechanical detection threshold, cool stimulus, and warm stimulus. Both walking velocity and cadence improved. No significant changes in hand dexterity or LANSS scores were reported.
The findings suggest that the topical application of menthol can improve symptoms of chronic chemotherapy-induced peripheral neuropathy.
This study is limited by its small sample size and study design, but shows promising proof of concept results related to molecular receptors in sensory nerves that appear to respond to topical menthol. Very few interventions have been shown to prevent or effectively treat chemotherapy-induced peripheral neuropathy, so further research on the use of topical menthol is warranted. Further well designed studies are needed.
Fallon, M., Hoskin, P.J., Colvin, L.A., Fleetwood-Walker, S.M., Adamson, D., Byrne, A., . . . Laird, B.J. (2016). Randomized double-blind trial of pregabalin versus placebo in conjunction with palliative radiotherapy for cancer-induced bone pain. Journal of Clinical Oncology, 34, 550–556.
To determine the effectiveness of pregabalin in conjunction with radiotherapy to treat patients with cancer-induced bone pain (CIBP)
This double-blind randomized study examined the concurrent use of pregabalin with palliative radiotherapy (versus placebo with radiotherapy) to prove the efficacy of use for treatment of CIBP. Patients were given 75 mg pregabalin or placebo twice daily for 35 days. Assessment of analgesia was done every seven days from baseline. If adequate analgesia was not achieved, trial medication was increased incrementally up to 300 mg twice daily. Radiotherapy was given in either one fraction of 8 GY or 20 Gy in five fractions.
No statistically significant differences in average pain, pain intereference, or quality of life were discovered. However, differences in mood and breakthrough pain duration, which was lesser in the pregabalin arm (p = 0.037), were present.
These findings do not support use of pregabalin in patients with CIBP receiving palliative radiotherapy.
Nurses providing care to patients in the outpatient setting are in prime position to conduct further research to determine the efficacy of adjunct medications and/or other treatment modalities used for treatment of CIBP and chronic cancer pain in general. Nurses may serve as principal investigators or coinvestigators in further research to determine the most effective interventions. Nurses may also serve to make recommendations for Putting Evidence into Practice (PEP) in outpatient cancer treatment settings, and in doing so serve as patient advocates. Findings do not support the use of pregabalin for metastatic bone pain in patients with cancer.
Fallon, M., Reale, C., Davies, A., Lux, A.E., Kumar, K., Stachowiak, A., & Galvez, R. (2011). Efficacy and safety of fentanyl pectin nasal spray compared with immediate-release morphine sulfate tablets in the treatment of breakthrough cancer pain: A multicenter, randomized, controlled, double-blind, double-dummy multiple-crossover study. Journal of Supportive Oncology, 9(6), 224–231.
To compare the efficacy and tolerability of fentanyl-pectin spray (FPNS) with that of immediate-release morphine sulfate (IRMS) in the treatment of breakthrough cancer pain (BTCP)
Patients in the study were experiencing 1–4 episodes of BTCP per day while taking at least 60 mg/day of oral morphine or equivalent for BTCP. Patients completing the titration phase continued to the double-blind, double-dummy phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (5 episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (PI) difference from baseline at 15 minutes. Secondary end points were onset PI decrease (≥ 1 point) and time to clinically meaningful pain relief. Safety and tolerability were evaluated by means of adverse events (AEs) and nasal assessments. By-patient and by-episode analysis were completed. Duration of follow-up was a maximum of 14 days in the open-label period.
Randomized, controlled, double-blind, double-dummy, multiple crossover trial
The pain intensity difference associated with FPNS was greater than that associated with IRMS. The difference between the two measures of pain intensity was statistically significant (p < 0.05).
For patients receiving around-the-clock opioid treatment for chronic cancer-related breakthrough pain, FPNS appears to be effective, safe, and well tolerated. The early reduction of pain that FPNS provided either matched or exceeded that provided by IRMS. Compared to IRMS, FPNS provided more complete pain relief. The effects of long-term use of FPNS have not been evaluated; nurses must be aware that long-term effects of FPNS on the nasal mucosa are unknown.
Falkowski, S., Trouillas, P., Duroux, J. L., Bonnetblanc, J. M., & Clavère, P. (2011). Radiodermatitis prevention with sucralfate in breast cancer: fundamental and clinical studies. Supportive Care in Cancer, 19, 57–65.
To determine if sucralfate has a role in the prevention of radiodermatitis. A 1% concentration of sucralfate in lotion was tested.
Several zones on the breast were laid out by the investigators, with one zone in the irradiated field left untreated, one with sucralfate, and one that was not within the field of radiation therapy (RT). All patients were instructed to apply sucralfate lotion twice a day, one to two hours prior to treatment and within two hours after RT.
Unspecified
The study used a quasiexperimental design—patients were used as their own controls.
No radioprotective effect was demonstrated with sucralfate.
Fahy, A.S., Jakub, J.W., Dy, B.M., Eldin, N.S., Harmsen, S., Sviggum, H., & Boughey, J.C. (2014). Paravertebral blocks in patients undergoing mastectomy with or without immediate reconstruction provides improved pain control and decreased postoperative nausea and vomiting. Annals of Surgical Oncology, 21, 3284–3289.
To evaluate whether paravertebral block use affected opioid use, antiemetic use, and length of stay in patients receiving mastectomies
Patient data were collected from medical records from the time periods before and after the use of paravertebral blocks (PVBs). Patients receiving unilateral mastectomies had unilateral PVBs, and those receiving bilateral mastectomies had bilateral PVBs. Blocks were placed preoperatively. All patients had general anesthesia. Prophylactic opioids and antiemetics were given intraoperatively at the discretion of the anesthesia team. Pain scores were documented with vital sign monitoring postoperatively. The results of those who had PVBs were compared to a cohort of patients who did not have PVBs.
Retrospective cohort comparison
In a multivariate analysis that was controlled for age and surgeon, there was no significant difference between groups in length of stay. The percentage of patients requiring antiemetics was higher in the no-PVB group (57 versus 39%, respectively, p < 0.00001). The amount of opioids required was higher in the no-PVB group on the day of surgery (47.6 versus 40.1 morphine equivalents, respectively, p < 0.0001). Despite differences in opioid consumption, there were no significant differences between groups in pain scores. The greatest difference in opioid consumption was seen in patients receiving immediate bilateral reconstructions.
The use of PVBs in patients receiving mastectomies was associated with lower antiemetic and opioid consumption on the day of surgery.
The findings of this study suggested that among patients receiving mastectomies, PVBs may reduce the need for postoperative antiemetics and opioids. However, it was not clear that the procedure actually reduced postoperative pain. This procedure appeared to be most beneficial for women having the most extensive surgical procedures. Additional well-designed research is warranted to determine the clinical benefits of PVB and its role in improving perioperative pain control.
Fabian, C. J., Molina, R., Slavik, M., Dahlberg, S., Giri, S., & Stephens, R. (1990). Pyridoxine therapy for palmar-plantar erythrodysesthesia associated with continuous 5-fluorouracil infusion. Investigational New Drugs, 8, 57–63.
Evaluate effectiveness of pyridoxine for treating PPE in patients with metastatic colon cancer who are receiving continuous 5-FU
Patients were treated with 5-FU 200 mg/m2 by continuous infusion (CI) until moderate to severe toxicity developed.
Five previously untreated patients who developed PPE were given oral pyridoxine (50 or 150 mg every day) when moderate PPE changes were noted.
Study conducted between September 1984 and July 1986.
N: 25
KEY DISEASE CHARACTERISTICS: Patients with metastatic colon cancer receiving continuous 5-FU infusion (200–300 mg/m2/day).
SITE: Multi-site
LOCATION: University of Kansas Medical Center; Fred Hutchinson Cancer Research Center
Skin toxicity was graded as follows.
PPE developed in 16 of the 25 patients. The five previously untreated patients who developed PPE received 50 or 150 mg of oral pyridoxine per day when moderate PPE changes were noted. Reversal of PPE without interruption of 5-FU was seen in four out of five patients, and these patients continued 5-FU for a median of six months after developing PPE.
Oral pyridoxine may reduce incidence and severity of PPE symptoms associated with 5-FU continuous infusion.
Fabi, A., Ciccarese, M., Metro, G., Savarese, A., Giannarelli, D., Nuzzo, C.M., … Cognetti, F. (2008). Oral ondansetron is highly active as rescue antiemetic treatment for moderately emetogenic chemotherapy: Results of a randomized phase II study. Supportive Care in Cancer, 16, 1375–1380.
To test the efficacy and safety of two different schedules of ondansetron as rescue antiemetic treatment in patients who were refractory to standard antiemetic prophylaxis for delayed emesis following moderately emetogenic chemotherapy (MEC)
Patients were randomly allocated to one of two treatment groups for rescue antiemetic treatment: intramuscular ondansetron 8 mg or oral ondansetron 16 mg for days two to six (antiemetic prophylaxis was provided by ondansetron 8 mg IV plus dexamethasone 8 mg IV for acute emesis and dexamethasone 8 mg for four days for delayed emesis).
The study was conducted at a single site, outpatient setting.
All patients were in active treatment.
The study design was a prospective trial (open label, phase II, randomly assigned to treatment group).
Oral ondansetron 16 mg was significantly superior to intramuscular ondansetron 8 mg for nausea and vomiting control during days two to six (p < 0.01). The two arms had a similar adverse event profile. A higher degree of personal satisfaction was found with oral ondansetron.
Because of its high efficacy and excellent tolerability, oral ondansetron is an important option in the management of MEC-related delayed emesis refractory to standard antiemetic prophylaxis.
The oral form of ondansetron could provide satisfactory rescue for breakthrough delayed emesis when compared to the Intramuscular form of ondansetron, with a similar adverse event profile.