This study was conducted to test whether methylphenidate (MPH) treatment would improve neurobehavioral functioning in patients with malignant glioma.

Participants were administered 5 mg of MPH daily, increasing dosage by 5 mg twice daily until a response or dose-limiting toxicity was noted.

• The number of participants was 30.
• The average participant age was 40.3 with a range of 15–70.
• 66.7% of participants were male and 33.3% were female. 
• 76.7% of participants had anaplastic glioma, 20% had glioblastoma multiforme, and 3.3% had medulloblastoma.

The study had a pre- and post-test design.

• Digit Span for attention
• Digit Symbol Substitution Task for graphomotor skills 
• Hopkins Verbal Learning Test for memory
• Controlled Oral Word Association Test (COWAT) for verbal fluency
• Trail Making Test (TMT) Parts A and B for visual attention, motor speed, cognitive flexibility
• Grooved Pegboard Test for motor speed and dexterity
• Beck Depression Inventory (BDI) for depression
• State-Trait Anxiety Inventory (STAI) for anxiety
• Functional Independence Measure (FIM) for functional ability to perform activities of daily living

Objective improvements were observed in psychomotor speed, memory, visual-motor function, executive function, and motor speed and dexterity (all p < 0.05). Subjective improvements in improved energy, improved ability to ambulate, better concentration, and brighter mood were reported.

There was a significant improvement noted in cognition that cannot be explained by improved mood or use of glucocorticoids. The authors suggest that stimulants such MPH improve motivation and drive.

• The study had a small sample size.
• The study was limited to patients with malignant glioma.
• The study did not specify how long each participant was treated with MPH before the post-test.
• There was a lack of long-term follow-up.
• Participants were given variable dosing, so the study cannot recommend one specific dose.
• There was a large variation in patient age. 

• STUDY PURPOSE: To examine the evidence of Chinese herbal treatment in oral mucositis
• TYPE OF STUDY: Systematic review

• DATABASES USED: PubMed, MEDLINE via OVID, Embase via OVID, Cochrane Database, and CNKI
• KEYWORDS: Chemotherapy, chemotherapy-induced, oral ulcer, mouth ulcer, oral mucositis, stomatitis, Chinese herbal medicine, medicinal herbs, Chinese herbs, traditional Chinese medicine, antioxidant, anti-inflammatory
• INCLUSION CRITERIA: All induced oral mucositis treated by Chinese herbal medicine that offered an English or Chinese medicine were included.  
• EXCLUSION CRITERIA: Articles investigating radiochemotherapy-induced oral mucositis were excluded.

• TOTAL REFERENCES RETRIEVED: 686
• EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Only articles that included oral mucositis treated by Chinese herbal medicine were included. Therefore, 632 articles were excluded, leaving 54 articles of which only 18 met the inclusion criteria.

• FINAL NUMBER STUDIES INCLUDED = 18
• TOTAL PATIENTS INCLUDED IN REVIEW: 1, 476
• KEY SAMPLE CHARACTERISTICS: Patients with oral mucositis, based on the World Health Organization Oral Toxicity Scale, who were treated with either a single herb or a combination of herbs involving more than one component

PHASE OF CARE: Active treatment

All reviewed studies reported positive effects of Chinese herbal treatment for chemotherapy-induced oral mucositis.

Additional well-designed RCT studies are needed, especially to look at the mechanism of action for each herbal remedy. Due to poor design in terms of treatment and control groups, it was almost impossible to evaluate which parts of the treatment concepts are responsible for the measured effects in the reviewed trials.

Some studies used more than one herbal treatment with different routes of administration; therefore, it was difficult to determine which agent may have been more effective in treating oral mucositis. In general, most trials had a poor design.

No recommendations for use in clinical practice were made; recommendations were made for further studies. These studies could use placebo capsules or placebo liquids. It also was recommended that future studies decrease the complexity of the treatments in order to determine what treatments were effective.

To compare the benefits of two interventions on anxiety in women after initial treatment for breast cancer

Women were randomly assigned to study groups in cohorts of 12 patients. One group received 15 sessions of a single-component support intervention, and the other received a 15-session group intervention combining support with psychoeducational interventions focusing on problem-solving skills, optimizing communications and use of personal and social resources, and self-hypnosis. Interventions were delivered in group settings by clinical psychologists following a structured manual. Sessions were audio and video recorded for use in clinical supervision as needed. Psychologists delivered only one type of intervention to avoid contamination. Study measures were obtained at baseline and after the intervention. All instruments were used with dynamic tasks through completion of the Mental Adjustment to Cancer (MAC) Scale followed by 12 minutes of self-relaxation and through completion of the Fear of Cancer Recurrence Inventory (FCRI) followed by a 12-minute guided hypnosis exercise.

• N = 159 in ITT, 130 completed the study   
• MEAN AGE = 50.6 years (SD = 10.1 years)
• AGE RANGE = 30–82
• FEMALES: 100%
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Women were either receiving radiotherapy or had completed radiotherapy within the past month; 79% had stage 1 or 2 disease.
• OTHER KEY SAMPLE CHARACTERISTICS: Forty-four percent were married or cohabitating, 17% were working full-time, and 66% had a high school or more education.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: France

PHASE OF CARE: Transition phase after active treatment

• Randomized, parallel-group trial

• 10-cm visual analog scale (VAS) for anxiety
• Heart rate
• Relaxation strategies questionnaire
• Hospital Anxiety and Depression Scale (HADS)
• Rating of everyday level of anxiety
• Mental Adjustment to Cancer (MAC) Scale
• Fear of Cancer Recurrence Inventory (FCRI) 

A significant group by time effect was observed in the multicomponent intervention compared to controls for state anxiety after self-relaxation (p = 0.006), for anxiety after guided hypnosis (p = 0.013), and for everyday anxiety level (p = 0.005). No differences were reported between groups in HADs scores. Anxiety and depression scores declined over time in both groups (p < 0.001). The item of psychological distress on the FCRI was reduced in both groups over time, with slightly better improvement in the multicomponent intervention group (p = 0.017).

Both supportive and multicomponent interventions were associated with a decline in anxiety and depression scores over time. The findings suggest that the multicomponent intervention was more effective in enabling women to manage their level of anxiety from triggers that could produce anxiety.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%  
• No report of any differences existed between groups in general demographic and disease variables that could have influenced the results.

Both supportive and multicomponent psychoeducational type interventions were associated with a decline in anxiety and depression over time; however, determining if these changes were associated with the general supportive atmosphere of the group-based intervention is not possible. Anxiety has been shown to decline over time in general as well, without specific intervention. The findings suggest that the combination of self-hypnosis techniques and psychoeducation may enable individuals to manage their anxiety responses more effectively.

STUDY PURPOSE: To summarize the available evidence regarding the extent to which exercise improves sleep in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 21
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,077
• SAMPLE RANGE ACROSS STUDIES: 23-301
• KEY SAMPLE CHARACTERISTICS: Sample mean ages ranged from 47-64 years. Varied tumor types were included. Breast cancer was most prevalent. Four studies had a quasiexperimental design.

PHASE OF CARE: Multiple phases of care

Sleep outcomes improved in 10 studies (47.6%). Interventions included home-based programs, supervised exercise, or a combination of these two approaches. Aerobic and resistance exercise were employed individually or in combination. Meta-analysis of 12 randomized, controlled trials showed no significant effect of interventions compared to control groups.

Analysis showed no clear significant effects of exercise interventions on sleep outcomes among patients with cancer.

Evidence from this analysis does not show an effect of exercise interventions on sleep quality. However, a large body of evidence regarding numerous other benefits of exercise for people with cancer exists. The analysis and most research have included patients who do not necessarily have clinical insomnia, so it would not be expected that interventions would improve sleep. Future research needs to be conducted among patients with clinically relevant insomnia.

To compare an APP-based cream and an aloe vera-based gel to determine effectiveness in preventing and treating radiation dermatitis

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by the radiation oncologist. Follow-up examinations were done four to six weeks after completion of radiation therapy, with completion of questionnaires and photographs.

• The study sample was comprised of 45 patients.
• Age ranged from 3–19 years, with a mean of 10 years.
• Of patients in the study, 16 had Hodgkin diseas, 10 a central nervous system tumor, 8 pediatric sarcoma, and 6 neuroblastoma.
• The radiation range was 25.2–67 Gy, with an average total dose of 34.3 Gy.
• Daily fractionation was 1.5–1.8 Gy.

The study took place at St. Jude Children’s Research Hospital in Memphis, TN.

The study used a quasiexperimental design in which patients served as their own controls.

• The primary end point was skin care failure, which included moderate-to-severe dryness, pruritus, erythema, and dry desquamation.
• Skin comfort assessment consisting of 15 items on a four-level scale was completed by the patient or the patient's parent.
• Dermatologic assessment questionnaire of negative items was completed by nursing staff.
• The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (was used.

Some patients rated the APP cream better in terms of comfort and skin dryness. Grouped NCI CTCAE scores were supportive of APP cream (p = 0.004)

APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.

• The applicability to adult patients has not been studied.
• No control group to enable determination of actual effectiveness of either product independently.
• The study had a small sample size, with less than 50 patients.
• Too much variation in time frame for follow-up visits.

To compare an anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).

• The sample was comprised of 45 participants. 
• Average age was 10 years (range 3–19).
• Gender was not listed.
• Patients had Hodgkin disease (16), central nervous system (CNS) tumor (10), pediatric sarcoma (8), and neuroblastoma (6).
• Average total radiation dose was 34.3 Gy (range 25.2–67 Gy). 
• Daily fractionation ranged from 1.5 to 1.8 Gy.

St. Jude Children’s Research Hospital, Memphis, Tennessee

The study used a quasiexperimental design. Patients served as their own controls.

The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.

Significant differences in specific variables favoring APP cream were noted in some patients, including:

• Skin comfort variables: dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), and smooth (p = 0.012)
• Dermatologic variables: dryness (p = 0.013), erythema (p = 0.002), and peely (p = 0.008).

Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. During RT, there was a difference in CTC scores, favoring the cream (p = 0.004). 

APP cream is more effective than aloe vera–based gel for the prevention and treatment of radiodermatitis.

• This was a study on pediatric patients; applicability to adult patients has not been studied.
• The study lacked a control group to enable determination of actual effectiveness of either product independently.
• The study had a small sample size.

To compare analgesic efficacy, adverse effects, need of increasing doses, and quality of life in patients with advanced cancer on morphine, fentanyl, and methadone

To compare the cost of pharmacologic pain management

Patients were randomized to morphine, fentanyl, or methadone. Morphine was offered as breakthrough pain medication at one-sixth of the equianalgesic 24-hour dose. Adjuvants were allowed. If the patient experienced poor opioid response or uncontrolled adverse events, he or she was switched to another opioid. Data were collected at weekly intervals for four weeks.

• The study reported on 108 patients: 36 in the morphine group (22 completed study), 36 in the fentanyl group (25 completed study), and 36 in the methadone group (23 completed study).
• Mean patient age was 59 in the morphine group, 57 in the fentanyl group, and 61 in the methadone group.
• The morphine group had 12 males and 10 females; the fentanyl group had 11 males and 14 females; and the methadone group had 11 males and 12 females.
• Patients had advanced cancer with pain and required first-line opioids for control.
• Patients were excluded from the study if they had liver or renal disease, had cognitive impairment, had less than three months’ survival, were undergoing radiation therapy, were undergoing a new course of chemotherapy, or had prevalent incident pain.
• Patients had mixed nociceptive and neuropathic pain, and breast cancer was the most frequent diagnosis.

• Multisite
• Outpatient setting
• Italy

 The study has clinical applicability for end-of-life and palliative care.

The study was a randomized controlled trial.

• Adverse events (AEs) rated on a 0–3 scale with “0” being not at all and “3” being severe; constipation measured on the number of passages per day
• Pain intensity (PI) scale (0–10)
• Number of daily dose changes to stabilization
• Opioid escalation index (OEI) = OMD–OSD/OSD per day x 100 where OMD represents doses administered at four weeks after study initiation and OSD represents the opioid starting dose at study initiation
• Spitzer Quality of Life Index
• Costs of opioid therapy

A similar number of patients in each group rotated to other opioids. There were no significant differences in the number of days to achieve dose stabilization, nor where there significant differences in the number of dose changes needed during titration. No differences existed in the PI of the three groups. OEI % was highest in the fentanyl group and significantly lower in the methadone group; 14 patients on methadone did not have a dose change, but 8 required a decrease in the dose and then a subsequent increase. There were no significant differences in quality-of-life scores between groups. Methadone was less expensive.

All three opioids were effective in controlling cancer pain in some patients. Adverse event profiles were similar. Methadone was less expensive compared to fentanyl and morphine but required clinical expertise in dosing due to the need to decrease and then increase the dose in some patients.

• The study had a small sample, with less than 100 patients.
• The study used a convenience sample and was not blinded.

Long-acting morphine, fentanyl, and methadone are effective in controlling pain in advanced cancer. Methadone is an option for patients where cost is a concern, but prescribing methadone requires clinical expertise.

To examine the effectiveness and side effects of transdermal buprenorphine in opioid-naive patients with cancer-related pain

Patients received an initial dose of transdermal buprenorphine: 17.5 mcg/hour, with patch changes every three days. For the treatment of breakthrough pain, patients received 5 mg oral morphine. Every 2–3 days, the transdermal buprenorphine dose was adjusted up to 70 mcg/hour. Each patient received adjuvant symptomatic drugs as needed. Patients were contacted weekly for adjustment of therapy. Patients completed rating scales of side effects and pain intensity at baseline, after 1 week, and at 4 weeks.

• Twenty-four patients completed all four weeks.
• Mean patient age was 67.2 years (SD = 11.9 years).
• Of all patients, 41% were female and 59% were male.
• The sample included multiple cancer types; gastrointestinal, breast, and lung cancers were the most frequent.

The setting type was unspecified. The site was Palermo, Italy.

Open-label observational trial

• Numeric scale, 0–10, to measure pain intensity
• Scale (0 = not at all, 3 = severe), to measure multiple symptoms
• Spitzer Quality of Life Index

• Pain intensity scores declined by 50% over the four-week period (p < 0.001).
• Transdermal buprenorphine dose increased significantly and had doubled by the end of the study. 
• Dry mouth and drowsiness were the most severe side effects.
• Of all patients, 15% discontinued the study because of poor compliance or the need for different pain management.

For the patients in this study, transdermal buprenorphine was effective for pain management and well tolerated.

• The study had a risk of bias due to no appropriate control group.
• The study had a relatively small sample.
• The duration of the study was very short; long-term effectiveness and side effects were not evaluated.
• The report provides mean scores regarding treatment side effects but does not provide the prevalence rates of the effects.

Authors pointed out that the World Health Organization analgesic ladder suggests a dose equivalent of approximately 35 mcg/hour.

To test the hypothesis that oxycodone has advantages over morphine in terms of efficacy and dose escalation in the treatment of pancreatic cancer pain

Patients were randomized to one of two groups: One group took 30 mg/day sustained-release morphine; the other, 20 mg/day sustained-release oxycodone. Clinicians increased doses as needed to treat pain that measured higher than 4 on a 0–10 rating scale or if the patient had more than three episodes of breakthrough pain per day. Patients in both groups used oral morphine, at one-sixth daily dose, to address breakthrough pain. Adjuvants were prescribed at the discretion of the clinician. Investigators collected data for four weeks. Patients could enter an extension phase that lasted eight weeks. Investigators followed patients in inpatient palliative care units, at home, and through outpatient care.

• The sample was composed of 39 patients, of which 17 patients completed the eight-week extension.
• Mean patient age was 63.2 years (SD = 9.48 years).
• Of all patients in the initially randomized group, 58.7% were female and 41.3% were male.
• All patients had pancreatic cancer. The study excluded patients with bone metastases.

• Single site
• Palliative care, home, and outpatient care
• Italy

Randomized controlled trial

• Numeric rating scale (0–10), to measure pain
• Rating scale (0–3), to measure side effects and symptoms

Authors noted no differences between groups in pain intensity or use of breakthrough medication. Pain decreased in both groups, in a similar pattern of decline. Dose escalation was similar in both groups. In regard to use of adjuvant pain medication, authors noted no differences between groups. Side effects were similar across groups, with the exception that patients receiving oxycodone had a greater increase in confusion over the course of eight weeks (p = 0.011). No difference in confusion was apparent between groups at any other time point.

This study revealed no differences in the analgesia and side effects associated with morphine and oxycodone, delivered according to similar dose escalation, used in the treatment of pancreatic cancer pain.

• The study had a small sample, with fewer than 100 patients.
• The study had a risk of bias due to no blinding.

This study suggests that, over an eight-week period, morphine SR and oxycodone SR provide similar analgesia with similar side effects. Whether differences would become apparent during a longer term is unknown.

To evaluate patient response to a combination of opioids and local anesthetics administered intrathecally to patients with advanced cancer and to evaluate treating patients with an oral-to-intrathecal-morphine ratio of 100:1, along with required changes in dosage

A cohort of patients with the indicated inclusion criteria received an intrathecal catheter in the operating room under aseptic conditions. The catheter was tunneled subcutaneously to the anterior abdominal wall and connected to a subcutaneous port. Morphine and levobupivacaine initially were started via a syringe pump to provide an infusion rate of 2 mL/h. Levobupivacaine was started at 12.5 mg/d, and morphine rate was calculated from the patient’s daily systemic dose using an oral-intrathecal ratio of 100:1. Doses of each drug were modified as needed to acceptably control pain (about 4 out of 10 on a numeric pain scale), and patients were monitored for adverse effects. Adjuvants, including clonidine and ketamine, were administered intrathecally as necessary. Patients were discharged seven days after the port implantation and converted to a balloon-type device instead of  syringe pump. The balloon-type device was changed every five days. Frequent follow-ups were completed over the phone or in person if possible. Pain and related symptoms were recorded prior to intervention; at hospital discharge; and at one-, three-, and six-month intervals, as well as at least one week prior to death.

• The study reported on 55 patients with advanced cancer. Complete data was available for 45 patients.
• The mean age was 60 years with a range of 33–82 years.
• The sample was 42% female (n = 23) and 58% male (n = 32).
• Patients had undergone previous pain management trials with at least three opioids and two routes of administration (including IV).
• Oral morphine equivalents at baseline averaged 466 mg/d.

This was a single-site study conducted at La Maddalena Cancer Center in Palermo, Italy.

This was a prospective trial.

• Pain intensity was measured using 0–10 numerical scale.
• Opioid-related symptoms, such as nausea and vomiting, drowsiness, confusion, constipation, and dry mouth, were measured using a numerical scale of 0–3 (not at all, slight, a lot, and awful).

• Statistical differences in pain intensity were found with daily dose escalation of intrathecal morphine doses. At the time of hospital discharge and by six months, pain intensity had gone from a mean of 7.98 to 3.0 (p < 0.0002).
• Systemic use of opioids significantly decreased along all measured points of time, up until death, following intrathecal catheter placement for pain control (p < 0.029).
• Symptoms of confusion (p < 0.0001) and constipation (p < 0.008) declined with intrathecal pain management. Early complications, occurring during the hospitalization period, included mild bleeding, headache, and urinary retention requiring bladder catheterization.
• One patient died unexpectedly during admission, and a second patient died after suffering a stroke. No relationship with the use of spinal analgesia was found.
• Two patients developed late complications of local infection. One of these patients required removal and replacement of the catheter.
• One patient developed spinal cord compression and did not proceed with intrathecal treatment.
• Overall, treatment was discontinued in 10 patients for different reasons, but these were not all described.

In patients who have received multiple trials and routes of opioids, intrathecal treatment may provide rapid and long-term relief. An oral-intrathecal morphine conversion ratio of 100:1 and use of local anesthetics may be effective for pain control in highly opioid-tolerant patients with advanced cancer.

• The sample size was small, with fewer than 100 patients.
• Patient and caregiver education was not documented.
• No comparison or control group was included.
• The authors did not discuss breakthrough pain, explain the reasons for all of the discontinuations, or describe the methods of measurement and analysis of complications.

This study was able to demonstrate an effective method and ratio for administration of intrathecal opioids for pain relief in patients with advanced disease. This may provide nursing with additional knowledge regarding appropriate dosages for medication administration, opportunities to develop staff educational sessions on the use of intrathecal catheter maintenance, and educational materials for patients and caregivers. This study suggests that this approach has promise; however, shortcomings in reporting all of the reasons for discontinuation in 18% of the initial sample are problematic. Intrathecal treatment is associated with some complications and caregiving needs for monitoring complications.