Davis, M., Lasheen, W., Walsh, D., Mahmoud, F., Bicanovsky, L., & Lagman, R. (2012). A phase II dose titration study of thalidomide for cancer-associated anorexia. Journal of Pain and Symptom Management, 43, 78–86.
To assess appetite response to thalidomide in cancer-associated anorexia
Patients with advanced cancer were given 50 mg of thalidomide at bedtime for two weeks. Those who responded to treatment were kept on the same dose for a total of six weeks. Those who did not respond to the 50 mg dose and were not experiencing dose-limiting toxicity were given 100 mg at night for two more weeks. If there was no response at 100 mg after two weeks and the patient was not having dose-limiting toxicity, the dose was escalated to 200 mg at bedtime.
A prospective, observational study design was used.
Thirty-three patients completed at least 14 days of therapy. Sixty-four percent of patients who had completed at least two weeks of thalidomide had statistically significant appetite improvement by both the NRS and CAT (p < 0.001). Other symptoms with statistically significant improved scores included pain (< 0.05), insomnia (night sleep) (< 0.01), and early satiety (< 0.05).
Thalidomide significantly improved appetite, insomnia, pain, and early satiety from baseline in patients with advanced cancer.
Thalidomide may provide benefit for appetite stimulation as well as some other symptoms of advanced disease; however, the drug is not without side effects that may interfere with quality of life. This was a small study, partially funded by a pharmaceutical company, so the results should be interpreted with caution. Patients with advanced cancers on thalidomide should be educated about and assessed frequently for toxicities that may erode what little quality of life they have. Nurses must advocate for their patients who are experiencing unacceptable toxicities.
Davis, I.D., Kiers, L., MacGregor, L., Quinn, M., Arezzo, J., Green, M., . . . Daly, M. (2005). A randomized, double-blinded, placebo-controlled phase II trial of recombinant human leukemia inhibitory factor (rhuLIF, emfilermin, AMg424) to prevent chemotherapy-induced peripheral neuropathy. Clinical Cancer Research, 11, 1890–1898.
Patients were randomized to one of three study arms: 36 in the recombinant human leukemia inhibitory factor (rhu LIF) 2 mcg/kg group, 39 in the rhu LIF 4 mcg/kg group, or 42 in a placebo group. The study drug or placebo was administered one day prior to chemotherapy by subcutaneous injection after premedication with acetaminophen 1 g orally. The patient was then observed for two hours. The second injection was administered the following day, two hours prior to chemotherapy. The study drug or placebo was continued by daily subcutaneous injections for a total of seven consecutive doses per treatment cycle (every 21 days for 4–6 cycles).
The study had a phase II, double-blind, placebo-controlled clinical trial design.
rhu LIF was fairly well tolerated, with five patients reporting adverse events that included lightheadedness, rigors or chills, myocardial ischemia, and hypotension. CPNE scores showed small but consistent decrement between baseline and cycle 4 of chemotherapy. Vibration threshold was also altered by chemotherapy. Intent-to-treat analysis showed no significant differences in CPNE scores between the three groups.
No evidence showed that rhu LIF prevented, delayed, or diminished CIPN.
While sample size was calculated to be adequate by a power analysis, the goal of 40 patients per group was not achieved, and the original calculation may not have been accurate to achieve statistical significance.
Since the measures were sensitive enough to detect CIPN, no further plans to develop rhu LIF as an agent to treat or prevent CIPN were proposed.
Davis, M.P. (2008). Oral nabilone capsules in the treatment of chemotherapy-induced nausea and vomiting and pain. Expert Opinion on Investigational Drugs, 17(1), 85-95.
Keywords searched were cannabinoids, nabilone, nausea, pain, tetrahydrocannabinol, and vomiting.
This was a review of published English literature, including reviews, meta-analysis, and treatment trials from 1975–1997 on using cannabinoids to control or prevent chemotherapy-induced nausea and vomiting (CINV), with very few trials found after 1997. From this review, 30 randomized control trials were found that looked at cannabinoids to control or prevent CINV. Overall, the trials received low scores for adequacy of randomization, blinding design, and description of withdrawal. Three cannabinoids were studied: nabilone (16), dronabinol (13), and levonantradol (1). The medications were compared to prochloperazine (12), placebo (10), metochlorpramide (4), chlorpromazine (2), domperidone (2), alizapride (1), thiethylperazine (1), and haloperidol (1). Twelve studies involved various scoring systems. No clear separation existed between acute and delayed CINV.
The trials included 1,760 patients, with 394 excluded.
Cannabinoids, like nabilone, may have a role in reducing delayed or refractory CINV, but more evidence is needed.
Davies, A.N., Dickman, A., Reid, C., Stevens, A.M., Zeppetella, G., & Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. (2009). The management of cancer-related breakthrough pain: Recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. European Journal of Pain, 13(4), 331–338.
The Science Committee of the Association for Palliative Medicine of Great Britain and Ireland convened a task group to produce up-to-date, evidence-based clinical guidelines regarding the management of cancer-related breakthrough pain in adult patients. Literature review provided limited evidence, only case series and expert opinion, and the task group could make no recommendations about any particular intervention.
Face-to-face group meetings initiated the review process and determined the scope of work. A draft set of recommendations was circulated to group members, and all members were in agreement regarding content. Authors did not describe the process of evidence grading or how the recommendations were drafted. A final meeting was held to finalize results. The MEDLINE keywords searched to retrieve reviews were breakthrough pain, incident pain, and episodic pain. The search was for the years 1950–2007. In addition to the MEDLINE search, investigators manually searched reference lists of retrieved papers and major texts. Authors did not specify inclusion or exclusion criteria. Evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) system.
The guidelines make the recommendations that follow.
Three members of the task force consult for pharmaceutical companies.
Breakthrough pain is heterogeneous and highly individual; clinicians and caregivers should approach it with these facts in mind. Little evidence guides the management of breakthrough pain. Current teaching is not in concert with recommendations related to the usual practice of prescribing a fixed proportional dose of background opioids as rescue medications. Guidelines point to the need to consider breakthrough pain as an issue separate from background pain. The use of rescue medications is only one aspect of managing breakthrough pain; clinicians should remember other approaches, such as treatment of the underlying causes of the pain. The field of oncology needs research aimed specifically at the management of breakthrough pain.
Davies, H.E., Mishra, E.K., Kahan, B.C., Wrightson, J.M., Stanton, A.E., Guhan, A., . . . Rahman, N.M. (2012). Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: The TIME2 randomized controlled trial. JAMA : The Journal of the American Medical Association, 307(22), 2383-2389.
The objective of the study was to determine if indwelling pleural catheters (IPCs) are more effective than talc slurry pleurodesis via chest tube for relief of dyspnea.
Patients with symptomatic malignant pleural effusion requiring pleurodesis were randomized to either IPC or talc pleurodesis. IPCs were inserted, initial large-volume drainage was performed, and caregivers were trained in IPC management. Drainage was advised to be done three times weekly. The IPC was removed if significant drainage stopped for at least four weeks, with no evidence of fluid reaccumulation. Patients in the talc group were hospitalized and had percutaneous chest tube insertion and talc slurry pleurodesis with 4 g sterile high-grade talc, following published treatment guidelines. Patients were followed up for 12 months after randomization. Dyspnea measurement was recorded daily for 42 days and then at 10, 14, 18, 22, and 26 weeks, and at 9 and 12 months.
The study was conducted in multiple settings in the United Kingdom.
The study was an unblinded, randomized controlled trial.
Because it was unblinded, the study had the risk of bias.
Davies, A., Sitte, T., Elsner, F., Reale, C., Espinosa, J., Brooks, D., & Fallon, M. (2011). Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. Journal of Pain and Symptom Management, 41(2), 358–366.
To compare the efficacy, tolerability, and patient acceptability of fentanyl-pectin nasal spray (FPNS) with that of immediate-release morphine sulfate (IRMS)
This study consisted of four phases: a screening phase (maximum 10 days), an open dose-titration phase (maximum 14 days), a treatment phase (minimum three days, maximum 21 days), and an end-of-treatment phase (1–14 days after the last dose). The open dose-titration phase was used to identify the FPNS dose, 100–800 mcg/episode of breakthrough pain, that was effective. Patients who achieved an effective dose in titration were eligible for the treatment phase. Five of a patient's breakthrough episodes were treated with FPNS and oral placebo and five episodes were treated with IRMS and placebo nasal spray. Scores rating pain relief were recorded at 5, 10, 15, 30, 45, and 60 minutes after treatment.
Randomized, double-blind/double-dummy (DB/DD) crossover study
This is a strong, well-conducted study that demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with breakthrough cancer pain.
FPNS is an effective alternative for management of episodes of cancer-related breakthrough pain. Nasal spray may be a route that is particularly helpful for patients who have to take a lot of oral medication. Nurses should be aware that most studies of nasal sprays have been of relatively short duration. Nasal sprays do not seem to have adverse effects on the nasal passages, but the potential effects of long-term use are unknown.
Davies, M. (2014). New modalities of cancer treatment for NSCLC: Focus on immunotherapy. Cancer Management and Research, 6, 63–75.
RESOURCE TYPE: Expert opinion
PHASE OF CARE: Active antitumor treatment
Provides general concepts for the management of immune-related adverse events
Davidson, J. R., Waisberg, J. L., Brundage, M. D., & MacLean, A. W. (2001). Nonpharmacologic group treatment of insomnia: a preliminary study with cancer survivors. Psycho-Oncology, 10, 389–397.
To examine the initial efficacy of a sleep therapy program developed for treating insomnia in patients with cancer.
Participants received multimodal cognitive-behavioral therapy in five weekly group therapy sessions followed by a final sixth session held four weeks later. The sessions included stimulus control therapy, relaxation training, sleep consolidation strategies, and strategies to reduce cognitive-emotional arousal. Outcomes measured included several sleep-related measures, and several European Organisation for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30) measures, including role functioning, insomnia, and fatigue.
The study was conducted at outpatient clinics at a major cancer center in Ontario, Canada.
Patients were undergoing the long-term follow-up phase of care.
This was a repeated measure, quasiexperimental study with no control group.
Sleep improved from baseline to four weeks and to eight weeks after the intervention. Improved sleep measures included the number of awakenings, wake after sleep onset, and sleep efficiency.
Davidson, J. R., Waisberg, J. L., Brundage, M. D., & MacLean, A. W. (2001). Nonpharmacologic group treatment of insomnia: a preliminary study with cancer survivors. Psycho-oncology, 10, 389–397.
Participants received multimodal cognitive-behavioral group therapy in six 1- to 1.5-hour sessions, given weekly x5 and then repeated in four weeks. Therapy included stimulus control therapy, relaxation training, sleep consolidation strategies, and strategies to reduce cognitive-emotional arousal.
Outpatient clinics at Major Cancer Center in Central Canada and the community serving the Cancer Center, Midwestern Canada
This was a repeated measure, single-group design with no control group.
Fatigue significantly decreased at week eight in comparison to baseline. Values of sleep, mood, and functioning improved from baseline, to four weeks, and to eight weeks after the intervention. Improved sleep measures included
Das, A., Chattopadhyay, S., Mandal, D., Chhaule, S., Mitra, T., Mukherjee, A., . . . & Chattopadhyay, S. (2015). Does the preoperative administration of tranexamic acid reduce perioperative blood loss and transfusion requirements after head neck cancer surgery? A randomized, controlled trial. Anesthesia, Essays and Researches, 9, 384–390.
To determine the effectiveness of a preoperative bolus dose of tranexamic acid on the amount of blood loss and transfusions required during surgery for patients with head and neck cancer
The study participants were randomly selected into two groups. One group received 25 ml of normal saline only (control group) over five minutes through the IV route. The second group received 20 mg/kg dose of tranexamic acid diluted in 25 ml of normal saline over five minutes through the IV route. Both groups received the intervention 15 minutes prior to the initiation of anesthesia prior to surgery. Labs were done preoperatively, and in the first 6 and 24 hours postoperatively.
Total blood loss was significantly higher in the control group when compared to the treatment group (p = 0.0001), requiring more blood transfusions both during the operation and at 24 hours post-procedure points. Even after transfusions, the control group’s hemoglobin remained significantly lower at 6 and 24 hours post-procedure (p < 0.05).
The use of tranexamic acid infusion prior to surgery for patients with head and neck cancer has shown significant reduction in blood loss during and following the procedure. With no reported adverse side effects with the use of this medication, the benefits outweigh any potential risks. The intervention will need to be studied in other disease state procedures to recommend use prior to all cancer surgeries.
Nurses practicing in the surgical oncology field will be interested in these findings, as they can help them improve patients' quality of life during and after surgery for head and neck cancer. By reducing the amount of allogeneic red blood cell transfusions patients receive, The use of tranexamic acid prior to surgery is improving lives by reducing the amount of allogeneic red blood cell transfusions patients need.