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.

• Seventy-nine patients completed the study.
• Mean patient age was 55.9 years (SD = 12.3 years).
• Authors did not specify the percentages of females and males in the sample.
• All patients had a cancer diagnosis, but authors did not provide details about cancer type, extent, or treatment.
• All patients were on a fixed schedule of opioids: a dose equal to or greater than 60 mg/day morphine.

• Multisite
• Outpatient
• 35 centers in Europe and India

Randomized, double-blind/double-dummy (DB/DD) crossover study

• E-diary that prompted the patient at specific time points to rate pain on an 11-point scale (0 = no pain, 10 = worst possible pain)
• Numeric scale to measure pain relief
• Self-report, of relief speed and reliability of the nasal spray, by means of a four-point scale that a patient used after completing a 10-item questionnaire

• Per-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than did IRMS (p < 0.05).
• Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 minutes (P < 0.01).
• Only 4.7% of patients withdrew from titration because of adverse effects; no significant nasal effects were reported.
• Overall, the percentage of episodes requiring rescue medication was similar between the two groups: Of all episodes of breakthrough cancer pain, 97% treated with FPNS did not require additional rescue medication and 96.2% treated with IRMS did not require additional rescue medication.
• Overall, only eight patients (six after treatment with FPNS and two after treatment with IRMS) experienced treatment-related adverse effects that resulted in the discontinuation of the study drug.

This is a strong, well-conducted study that demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with breakthrough cancer pain.

• The study had a small sample size, with fewer than 100 patients.
• Limitations of the study include its relatively short duration and the lack of IRMS titration.

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.

RESOURCE TYPE: Expert opinion

PHASE OF CARE: Active antitumor treatment

• Antidiarrheals for grade 1 diarrhea, and corticosteroids if diarrhea progresses to grade 2
• Systemic corticosteroids for severe, persistent, or recurring adverse events
• Dose delay for moderate adverse events until recovery and discontinuation of treatment for severe reactions

• Expert opinion level evidence
• Provides an overall general approach to the management of adverse events rather than specific treatment algorithms

Provides general concepts for the management of immune-related adverse events

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 comprised of 14 participants, 12 of whom completed the study.
• Mean age was 54.7 years.
• Participants had mixed cancer diagnoses.
• Mean time from diagnosis was 33.6 months.

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 diary
• Sleep Impairment Index (SII)

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.

• The study had a small sample size.
• The participants were relatively healthy.
• The study only used self-reported data.
• There was no placebo control group.
• The duration of effects after eight weeks was unknown.
• Space was needed to provide the intervention.

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.

• Fourteen patients, including 11 women, were included, and 12 completed the study.
• Mean age was 54.7 years. 
• Median time from diagnosis was 33.6 months.

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 subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Sleep
• Anxiety
• Depression

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

• Number of awakenings
• Wake after sleep onset
• Sleep efficiency
• Sleep Impairment Index.

• The study had a small sample size.
• Participants were relatively healthy.
• Only self-reports were used.
• There was no placebo control group.
• The duration of the effects after eight weeks is unknown.
• Space to provide intervention.

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.

• N = 80
• AGE = 35–55 years
• CURRENT TREATMENT: Surgery
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer having surgery
• OTHER KEY SAMPLE CHARACTERISTICS: No significant results

• SITE: Single site
• SETTING TYPE: Tertiary care hospital
• LOCATION: India

• PHASE OF CARE: Active antitumor treatment

• Double-blind randomized, controlled trial (RCT)

• Student’s t test
• Chi-squared test

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.

• Small sample (less than 100)
• Optimal dose of tranexamic acid would need to be tested with a larger study.
• Study done in developing country limited the types of biochemical parameters of bleeding episodes measured.

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.

To evaluate the effect of glutamine on intestinal absorption and permeability in patients with colorectal cancer

Patients receiving their first cycle of chemotherapy with 5-fluorouracil (5-FU) and folinic acid (FA) for five days were randomly assigned to receive either 18 g glutamine or placebo for 15 consecutive days, beginning 5 days before chemotherapy initiation. The experimental dose (18 g) was much greater than the normal dietary intake (1 g).
 

This study reported on 70 patients with colorectal cancer who were chemotherapy naïve. 

This was a randomized, double blind, placebo-controlled, two armed, parallel trial.

Intestinal absorption (IA) was measured using d-xylose absorption test and intestinal permeability (IP) using cellobiose-mannitol permeability test.  Both of these tests have been confirmed to be reliable and sensitive in clinical conditions characterized by disruption of the normal small intestinal mucosa (e.g., celiac disease, Crohn’s disease).

• For both groups, chemotherapy induced worsening of IA and IP. When pretreatment IA was compared to post-treatment IA, reduction in IA was significantly greater in the placebo group (p = 0.02).
• The placebo group experienced a higher incidence of diarrhea, but this was not statistically significant (p = 0.09).
• The placebo group used significantly more loperamide (p = 0.002). No differences were found in episodes of nausea, vomiting, or hematologic toxicity.
   

Glutamine was shown to reduce changes in IA and IP during 5-FU chemotherapy and may have a protective effect against diarrhea by enhancing the barrier function of the intestine.

• The sample size needed for statistical analysis was 70, but only 62 patients were included in the final analysis.
• The findings are applicable to chemotherapy using 5-FU and FA only.

This study used sensitive and reliable tests to evaluate the morphological changes to the intestine that are casually related to diarrhea incidence. The results are consistent with previous studies that have demonstrated the protective effects of glutamine on the intestinal mucosa.

To determine the feasibility of conducting a randomized, clinical trial testing the effectiveness of healing touch (HT) for patients undergoing induction for acute leukemia and to obtain preliminary data to determine the effect size.

A prospective cohort of patients was selected to participate in the intervention trial. They completed self-report questionnaires and rated fatigue, nausea, pain, and distress at baseline, within seven days of hospital admission. Follow-up data collection was performed during the fifth week of hospitalization or prior to discharge. The HT intervention consisted of nine 30-minute sessions during weeks 2, 3, and 4. Family members were allowed to stay or leave during the session, depending on patient preference. All who provided the sessions were certified and had at least two years of experience with HT. All sessions were provided to the patient by the same practitioner. Sessions were standardized and included (1) the practitioner setting an intention for the patients’ highest good and (2) a standardized sequence of hand positions progressing from the ankles upward to the top of the head, with the hands placed either touching the patient or several inches above the body for one minute.

• The sample was comprised of 12 patients (33.3% male, 66.7% female).    
• Mean age was 59.8 years (standard deviation = 10.7 years).
• Of the patients, 91.7% had acute myeloid leukemia (AML), 8.3% had acute lymphoblastic leukemia (ALL), and 66.7% were in relapse.
• Of the patients, 75% had at least some college level education, 50% were employed, and 100% were white.

• Single site  
• Inpatient 

Patients were undergoing the active treatment phase of care.

The study was a prospective trial.

• MD Anderson Symptom Inventory (MDASI):  13 symptoms rated from 0 (not present) to 10 (as bad as you can imagine) for severity; six items rate the degree to which symptoms interfered with functioning on the same type of 11-point scale
• Women’s Health Initiative Insomnia Rating Scale (WHIIRS):  five-item measure of sleep quality
• Profile of Mood States Short Form (POMS-SF):  37 items on a five-point Likert scale
• Distress Thermometer
• Self-rating of symptoms on a 0- to 10-point scale
• Questionnaire to obtain general feedback on the HT intervention
   

Of the individuals approached for study participation, 48% declined (66% due to lack of interest and 34% due to medical issues or feeling too ill). Three patients who initially entered withdrew, one due to family request and concerns about interference with medical treatment, one due to medical complications, and one after speaking with his minister who had religious objections to participation.

There were no significant changes from baseline to the five-week follow-up measurement on the MDASI, sleep quality measures, or POMS.

There were significant improvements on the patient self-report scale for fatigue (–1.8 change; p < 0.01) and nausea (–0.5 change; p < 0.01). Changes in distress were not significant. There were no changes in pain, and baseline values for pain were low (median = 1), although patient feedback suggested short-term pain reduction and improved sleep.

Of the patients, 91% liked HT “very much,” and most stated they felt more calm and relaxed during and after the sessions. All said they would recommend HT to others, and eight patients (73%) wanted to continue using HT.

Patients suggested improvements of providing a better explanation of HT, offering longer and more frequent sessions, and offering 30 minutes of protected quiet time for patients in addition to HT sessions.

The study demonstrated that use of HT in the acute setting is feasible and may benefit patients.

• The study had a very small sample size. 
• No comparison group was included. 
• Because patients suggested protected quiet time, it is not clear if the benefits seen were from the HT or from the fact that the sessions provided such uninterrupted time.

The study findings suggest that a simple intervention of providing protected, uninterrupted quiet time to patients can be helpful to patients. This is something that could be readily incorporated into nursing care. Findings suggest that further research in this area is feasible in acutely ill patients. Findings suggest that provision of quiet time control in further research would be a viable approach, as well as comparison to other strategies to elicit a relaxation response. Information regarding drop-out reasons suggest that more extensive explanation of HT and mechanisms of effects is warranted with use of HT.

To evaluate the effectiveness of lymphatic venous anastomosis (LVA) in the treatment of one-sided, breast cancer-related lymphedema

Unilateral lymphoscintigraphy was done with attention to liver uptake, and methylene blue was used to outline the lymphatic system. An experienced microvascular surgeon did the LVA procedures doing end-to-side anastomoses with micro instruments. Antibitoitics were used preoperatively, and the extremity was bandaged and elevated at night. Patients were followed at three months, six months, one year, and beyond. The mean final follow up was eight years.

• The study sample was comprised of 10 female patients.
• Mean age was 58.7 years, with a range of 46-68 years.
• All patients were postmastectomy and had persistent lymphedema that had not responded to more conservative interventions.
• Lymphedema was present for a mean of 5.3 years before LVA.

The study took place at a single site in the Netherlands.

The study used a prospective descriptive design.

• Arm volume was measured using inverse water volumetry method.
• The SF-36 measured quality of life. 
• Indirect circumferential measurement of limbs was taken.
• Patients underwent lymphoscintigraphy. 

After six months, 5 of 10 patients had subjective relief according to SF-36 results. After one year, the mean volume difference between limbs was 1,075 cc, with a range of 500-1856, and the circumferential measurement demonstrated improvement of 4.8%. An initial postoperative volume reduction seen at 16% was lost in one year, at which time no more than a 2% difference between limbs was observed.

No significant improvements were found over the long term after an initial period of symptom relief and volume reduction.

• The study sample was small, with less than 30 patients.
• The study did not have a comparison or control group. 

The small prospective study suggests there is no long-term benefit of LVA surgery for management of lymphedema associated with breast cancer.

To determine whether there is a difference between low- and high-pressure bandaging in intended volume reduction

Bilateral arm volume was measured before, two hours post-bandage placement, and after 24 hours. The amount of edema was calculated. Sub-bandage pressure was measured after bandage application and two hours later. Bandages were re-applied and pressure measurements were repeated. After 24 hours, pressure measurement was recorded and bandages were removed for final volumetry. Primary outcome measures were reduction of arm volume and edema in both study groups. Secondary outcomes were changes in sub-bandage pressure and patient comfort later. Patients were randomized into two groups: group A received low pressure bandages (20–30 mm Hg) and group B received high pressure bandages (44–58 mm Hg). 

• The sample (N = 36) was comprised of female patients aged 45–84 years.
• All patients had unilateral breast cancer-related lymphedema (moderate-to-severe edema [volume difference 20%–40% and greater than 40%, respectively).
• Patients were included in the study if they were at least 18 years of age, a minimum of 12 months post-treatment for breast cancer without signs of recurrence, and hospitalized because outpatient treatment was not successful.
• Patients with allergies to any of the materials, severe systemic diseases, acute superficial or deep vein thrombosis arterial occlusive disease, or confirmed thrombophilia were excluded.

The study took place at Nij Smellinghe Hospital in Drachten, Netherlands.

The study used a randomized, controlled comparative design.

• Bilateral arm volume was measured by inverse water volumetry.
• Sub-bandage pressure was measured after bandage application and two hours.
• The main outcome measures were reduction of arm volume and edema volume in the affected arm in both study groups.
• Secondary outcome parameters were changes in sub-bandage pressure and patient comfort.
• Air-filled pressure transducer with a large probe was used to measure sub-bandage pressure.
• Accuracy and variability of this method was referenced.

Median arm volume reduction after two and 24 hours was 104.5 ml (95% confidence interval [CI], 51.2–184.2) (–2.5%) (p < 0.0001) and 217 ml (95% CI, 143.9–280.2) (–5.2%) (p < 0.01) for group A and 56.5 ml (95% CI, 2.7–123.1) (not significant) and 167.5 ml (95% CI, 105.2–316.1) (–4.2%) (p < 0.01) for group B, respectively. There was no statistically significant difference between the volume changes in group A and group B. Bandages in group A were better tolerated. The sub-bandage pressure drop in the first two hours was between 41% and 48% in both treatment groups at both measuring sites. After 24 hours, the pressure drop was between 55% and 63%. No proximal swelling above the bandage was observed.

Inelastic, multi-layer, multi-component compression bandages with lower pressure (20–30 mm Hg) were better tolerated and achieved the same amount of arm volume reduction as bandages applied with higher pressure (44–58mm Hg) in the first 24 hours.

The sample size was small (N < 100).

More studies are needed to evaluate efficacy of lower pressure to better understand optimal treatment and tolerability, which will impact compliance.

To demonstrate that therapeutically intended volume reduction of the compressed leg is the most important cause for the loss of bandage pressure

All patients and control group volunteers were treated with the same bandages by trained staff. The bandages started at the base of the toes and covered the leg up to the capitulum fibulae in all cases. The bandages were removed after two hours, and new bandages were applied for the next 24 hours. On the first day, all patients were encouraged to walk and treated exclusively with compression therapy of the whole leg. No other therapeutic interventions were performed.

• The sample size (N = 29) was comprised of 20 patients (75% female and 25% male) for the study group and 9 healthy volunteers for the control group. 
• Mean age of the study group only was 51.1 years with a range of 20–78 years. Mean age for the control group was not available. 
• The study group consisted of patients who had been hospitalized for extensive lymphedema of the lower extremities.

• Single site
• Inpatient unit
• Netherlands

The study used an experimental, controlled comparative design.

• Sub-bandage pressure was measured by an air-filled pressure transducer.
• A water displacement device was used to measure leg volumetry.

A significant reduction of leg volume was achieved two hours after bandage application in both groups. A further volume decrease of the lymphedematous legs was observed in the following 24 hours after application of a new bandage. The volume reduction was associated with a significant loss of bandage pressure.

Volume reduction is the most important cause of loss of pressure and effectiveness, supporting the need for proper materials, technique, and compliance.

• The sample size was small (N < 30). 
• The study was conducted at a single site.

More frequent bandage changes, in the initial phase of edema reduction in patients with venous diseases, with compression treatment using short-stretch bandages appears to be necessary.