To compare senna versus lactulose in relation to efficacy and adverse events in patients with terminal cancer.

Lactulose, an osmotic laxative, is a synthetic disaccharide. Senna acts mainly in the large intestine, directly stimulating the myenteric plexus and increasing water and electrolyte secretions, thus stimulating peristaltic activity. Their action extends over six to 12 hours. Side effects are abdominal pain, nausea, vomiting, and diarrhea.

Group A received senna BID starting at 0.4 ml (12 mg). Group B received lactulose BID starting at 15 ml. Based on clinical response, doses were increased in increments of 0.4 ml and 15 ml, respectively, every three days. Max doses were 1.6 ml (48 mg) for senna and 60 ml (40 g) for lactulose.

When patients reached the ceiling of their respective laxative and had three days without defecation, they were maintained on that dose and, in the absence of side effects, were started on an initial dose of another laxative, which could then be increased at three-day intervals until reaching the experimental maximum. Enema or mechanical bowel evacuation was prescribed after a three-day period without defecation (for ethical reasons), and was recorded as a failure with increase in laxative dose. If no results occurred from mechanical evacuation after six hours, patients were held on standby outside of the study until defecation. 

The randomization schedule was stratified for age and gender (limit of eight per stratum). The study period was seven days to assess laxative efficacy on defecation days and at variable opioid dosage, and 27 days to assess mean morphine dose at which a laxative was necessary. Both laxative and opioid treatments were initiated simultaneously. Prescribers were blinded (single doses of identical volume in closed opaque flasks).

• The study reported on a sample of 91 patients with terminal cancer; 43 patients were assigned to the senna arm and 48 patients were assigned to the lactulose arm. 
• Patients were aged older than 18 years and were in a palliative care program from July 1, 1993, to July 1, 1995.
• Mean patient age was 67.8 years (range 41–93). 
• All patients had clearly documented terminal disease with a life expectancy less than six months, and caregivers in the home.
• Thirty percent had lung cancer, 11% had breast cancer, and 9% had stomach cancer. 
• Patients were excluded if they had contraindications to the experimental laxatives, including colectomy, steatorrhea, or aphagia; a Karnofsky performance status lower than 10%; or taken opioids (codeine or morphine) or laxatives within 72 hours prior to initiation of the study.

The study took place at a palliative care unit (PCU) in Madrid, Spain. The PCU assists patients who are released from the local hospital and is responsible for home care follow-up protocols.

This was a comparative study with a randomized, open, parallel-group design.

• Outcome measures were defecation-free intervals of 72 hours, number of days with defecation events, and general state of health (rated on a five-point Likert-type scale).
• Defecation days as a function of opioid dose and treatment cost also were examined.
• Laxative efficacy was analyzed by t-test and ANOVA.

• Of 91 patients, 75 completed the study for at least seven days and were evaluated in the analysis.
• Sixteen patients abandoned the study within four days and were not included in the analysis. Reasons for leaving were diarrhea (n = 1), noncompliance (n = 4), dying within the first 24 hours (n = 4), permanent hospitalization (n = 5), and moving out of the jurisdiction of the home care area (n = 2).
• Opioid dose did not determine laxative efficacy.
• By the end of the study, 37.5% of patients required both laxatives.

No difference existed between senna and lactulose in efficacy as measured by defecation-free intervals, days with defecation, or adverse effects. Senna use is recommend based on its lower cost. The description of the study design was very precise and detailed.

• Patients could differentiate medications by taste and texture.
• Data were based on self-report, which is not considered reliable.
• The study was done in Spain, so results may not be transferable to a U.S. population.
• The sample size was fewer than 100 patients in the final analysis.
• Baseline effects of diet, age, tumor type, and mobility were not discussed in relation to the results.

To examine the effect of therapeutic touch (TT) on pain and fatigue in patients undergoing chemotherapy.

Patients were randomized to one of three groups:  the TT group; the placebo group, which underwent a procedure that mimicked TT; or the control group, which received standard treatment. Interventions were used for five days. Patients in the TT group received 30 minutes of TT delivered by a trained researcher. The same researcher delivered all interventions.

• The study was comprised of 90 women (30 patients in each group).
• Mean age was 36.86 years in the TT group, 42.70 years in the placebo group, and 43.30 years in the control group.
• All patients were receiving inpatient cancer treatment.

• Three inpatient units (Whether they were at one site or multiple sites is unknown.)
• Iran

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for end of life and palliative care.

The study was a randomized, controlled trial with an intervention group and a usual care control.

• 10-point, 10-cm visual analog scale (VAS) (patient marked line for pain score)   
• Rhoten Fatigue Scale (RFS), 0 to 10 scale (0 = no fatigue, 10 = as much fatigue as I can bear)

• The pain scores of the TT group were lower than the pain scores of the placebo and control groups (p = 0.04).
• The fatigue scores of the TT group were lower than the scores of the placebo and control groups (p = 0.002).
• On some days, the scores of the placebo group were significantly lower (p < 0.05) than the scores of the control group.
• At all times, the fatigue scores of the TT group were lower than the scores of the placebo and control groups (p < 0.05).

TT was more effective at decreasing pain and fatigue than were placebo and control treatments. The placebo arm showed \"control\" that was superior to that in the control group.

• The study had a small sample size, with less than 100 patients.
• The sample was comprised of Muslim women in Iran, which may affect the applicability of the findings.
• The authors did not describe the actual intervention.

TT may decrease pain and fatigue scores in patients undergoing chemotherapy. The fact that a therapist must receive significant training to deliver TT may affect the practicality of the intervention.

STUDY PURPOSE: To review randomized, controlled trials evaluating the effect of telehealth interventions on pain, depression, and health-related quality of life outcomes in cancer care

TYPE OF STUDY: Systematic review

DATABASES USED: PubMed, EMBASE, Google Scholar, CINAHL, and PsychINFO

KEYWORDS: Neoplasms, cancer remote consultation, mHealth, connected health, text messaging, telemedicine, telehealth, ehealth, telephone therapy, teleconsultation, mobile technology, telecare, internet, digital health, mobile phone, smartphone, apps, and mobile application

INCLUSION CRITERIA: Reported the effect of telehealth on pain, depression, or quality of life in patients with cancer; randomized, controlled trials

EXCLUSION CRITERIA: Not stated

TOTAL REFERENCES RETRIEVED: 4,929

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Collaboration’s risk of bias tool 

• FINAL NUMBER STUDIES INCLUDED = 20 
• TOTAL PATIENTS INCLUDED IN REVIEW = 3,654
• SAMPLE RANGE ACROSS STUDIES: 25–571 patients 
• KEY SAMPLE CHARACTERISTICS: Patients with cancer, access to telehealth, and smart phones; English-speaking; high-income countries; most were studies of patients with breast cancer

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Pediatrics, elder care, and palliative care

Many of the included studies were telephone-based interventions with the interventions provided by professionals or peer counselors. Five studies used a web-based delivery of the intervention. The duration of the interventions ranged from one week to 12 months with a median of 12 weeks. Three studies examined the effect on pain; two of these showed a significant positive effect of the intervention, and one showed no difference between the groups. Nine studies examined the intervention effect on depression; four of these showed positive effect on depression while five showed no significant effect. Eight studies examined quality of life, and one measured well-being.

This review showed mixed results for the effects of technology-based interventions on pain and depression among patients with cancer.

There were few included studies, and most of them were done in high-income populations that were tech-savvy. There was high heterogeneity in the outcomes. Many of the studies had a high or unclear risk of bias.

It may be worthwhile to use telehealth applications with tech-savvy, high-income patients. These types of interventions are worthy of additional study to fully determine the efficacy of these interventions for symptom management.

To evaluate the safety and efficacy of (177)Lu-EDTMP for the palliation of pain from bone metastases

Patients with documented bone metastases from prostate or breast cancer were randomly assigned to two groups. One received low-dose and one received high-dose (177)Lu-EDTMP. The radiopharmaceutical was given over one minute via an indwelling IV catheter. Patients were examined at one, two, four, six, eight, 12, and 16 weeks.

• N = 44  
• MEAN AGE = 66 years (males), 47 years (females)
• MALES: 72%, FEMALES: 28%

• PHASE OF CARE: Active antitumor treatment

Randomized, parallel-group trial

• Analgesic score (0 = no analgesic, and 4 = regular opioids)
• Visual Analog Scale (VAS) for pain severity (> 70% VAS decrease = complete response, 40%–70% decrease = partial response, 20%–40% decrease minimal response, and < 20% decrease = no response)
• Bone lesion score based on skeletal scintigraphy
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Overall, 13% of participants experienced a complete responses to the intervention, 48% had partial responses, and 25% had minimal responses. VAS scores were significantly lower at all time points compared to baseline (p < 0.0001) with progressive decreases till four weeks. There was no change between weeks four and eight, and thereafter, pain increased significantly. There were no significant differences in responses between the high- and low-dose groups or between patients with prostate and breast cancers. Grades 3–4 toxicities were seen in 23% of patients, including anemia. The median hemoglobin nadir occurred at three weeks, and the median time to recovery was six weeks. Leukocyte and platelet nadirs occurred at four weeks and recovered to baseline after eight weeks. There was no relationship between pain responses and bone lesion scores.

The radiopharmaceutical tested here was effective in relieving pain from bone metastases in patients with prostate and breast cancers, and it was associated with few high-grade toxicities. Low- and high-dose treatments had similar efficacy.

• Small sample (< 100)
• Risk of bias (no blinding)

This study added to the body of evidence regarding the efficacy of radiopharmaceuticals for pain relief from bone metastases. Various agents have shown different durations of pain-free periods. Nurses need to be aware that bone marrow toxicity is a major dose-limiting factor with radiopharmaceuticals, and patients who receive these agents should be monitored for toxicity. Additional research directly comparing the efficacy and duration of various radiopharmaceuticals' effects is needed.

The study examined estosterone replacement therapy (TRT) after primary treatment for prostate cancer for the management symptoms.

Patients were placed on topical, transdermal, or intramuscular testosterone formulations and followed at regular intervals (every two months) with determinations of serum total testosterone and prostate-specific antigen (PSA) level.

Ten men, with a mean age of 63.4 years, were enrolled.  Participants were identified between 1993 and 2003, had no evidence of disease by clinical and PSA criteria. They presented postoperatively with complaints of decreased libido, erectile dysfunction, lack of energy, cognitive impairment, or hot flashes.

The study was a retrospective case review of patients with organ-confined prostate cancers that were subsequently treated for hypogonadism with testosterone replacement therapy.

At each two month visit, the participants completed the hormone domain of the Extended Prostate Inventory Composite (EPIC) Health-Related QOL questionnaire without any assistance form a healthcare provider.

Median duration of treatment was 19 months. During the course of therapy, no patient had a PSA recurrence. The hormone domain of the EPIC questionnaire increased significantly from 38 to 49, primarily due to a reduction in hot flashes and an increase in energy level.

A few case reports suggest that short-term TRT can cause an increase in PSA and convert an occult lesion into a clinically apparent one.

Baseline serum PSA and digital rectal examination must be performed along with baseline serum free and total testosterone. Also patients must be followed frequently, especially if baseline prostate biopsy is not performed. A large placebo-controlled, multicenter prospective trial to evaluate the feasibility of TRT in patients with hypogonadism after radical prostatectomy is indicated.

To identify rational, effective, and cost-effective treatment approaches for patients with constipation.

In this evidence-based guideline, material was selected from reviews and focused literature searches of peer-reviewed published studies.

Databases searched, search keywords, and inclusion criteria were not stated.

Studies were excluded if they reported on children or patients with constipation as a secondary symptom caused by problems such as spinal cord injury.
 

The study has clinical applicability to older adult and palliative care.

Evidence was categorized according to the U.S. Preventive Services Task Force grading system. Rome II criteria were used to define constipation. The resource identified causes of constipation, approaches for assessment, and recommendations for management based on evidence review. In addition to opiates, other causative agents associated with constipation in patients with cancer were antidepressants, anticholinergic agents, vinca alkaloids, vincristine, and cyclophosphamide.

• No evidence suggests increasing fluid intake improves constipation.
• Increased physical activity is associated with less constipation.
• Data are limited regarding the impact of probiotics on constipation.
• Dietary fiber has potential therapeutic benefits, and fiber supplementation should be considered as a first step in patients with chronic constipation. However, the quality of evidence in this area is low.
• If needed, osmotic agents should be used regularly and supplemented with stimulant laxatives as rescue medication, although the quality of evidence is moderate at best.

Limited high-quality evidence exists for effective interventions in managing constipation.

To evaluate if oral daily vitamin E is an effective agent in preventing oxaliplatin-induced peripheral neuropathy

Patients were randomized to receive either an oral placebo daily or 400 mg of oral vitamin E daily starting five days before their oxaliplatin-based regimen and continued until completion of the oxaliplatin-based regimen. Both groups received calcium 1 gram IV and magnesium 1 gram IV supplementation 30 minutes before and the same dose after the completion of 12 cycles of oxaliplatin infusions.

• N = 32 (18 in the vitamin E group, 16 in the placebo group)  
• MEAN AGE = 56 years in the vitamin E group; 57 years in the placebo group
• MALES: 10 in the vitamin E group, 8 in the placebo group; FEMALES: 8 in the vitamin E group, 8 in the placebo group
• KEY DISEASE CHARACTERISTICS: Equal distribution of colon cancer, rectal cancer, and advanced gastric cancer; metastatic colon cancer: three in the vitamin E group, zero in the placebo group
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group score 0–1: equal distribution; FOLFOX, FLOX, and EOX regimens: equal distribution; diabetes: two patients in the vitamin E group, zero in the placebo group; previous chemotherapy, radiotherapy, and ETOH consumption: equal distribution
• EXCLUSION CRITERIA: Patients with previous history of peripheral neuropathy or symptoms of peripheral neuropathy; patients receiving gabapentin, carbamazepine, amitriptyline, amifostine, or multivitamins

• SITE: Department of hematology and oncology
• SETTING TYPE: University hospital  
• LOCATION: Santo Andre, Sao Paulo, Brazil

• PHASE OF CARE: Adjuvant, advanced, and metastatic
• APPLICATIONS: Elder care, palliative care

• Prospective, phase II, randomized, double-blind pilot study

• Common Terminology Criteria for Adverse Events (version 3) and gradation scales for oxaliplatin based on National Cancer Institute Common Toxicity Criteria in the assessment of chemotherapy-induced peripheral neuropathy to detect a 50% decrease in the incidence of peripheral neuropathy with a power of 0.8 and a type I error of 0.05

In evaluating the effectiveness of oral vitamin E 400 mg daily for prevention of oxaliplatin-induced peripheral neuropathy, this study sought to detect a 50% reduction in associated peripheral neuropathy. The results showed no significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy comparing vitamin E and placebo groups (p = 0.43) and no significant difference in the grade (p = 0.45) or time to onset of peripheral neuropathy (p = 0.66) between groups. Incidence of vomiting, nausea, mucositis, fatigue, headache, vertigo, and bleeding observed between groups showed no statistical difference. Incidence of diarrhea was increased in the vitamin E group (p = 0.06).

There is no difference in the incidence, grade, or time to onset of peripheral neuropathy when comparing vitamin E given at 400 mg orally daily or placebo in patients receiving 12 cycles of an oxaliplatin-based regimen (i.e., FOLFOX, FLOX, EOX).

• Small sample (less than 100)
• Measurement/methods were not well described. All time points for evaluation of peripheral neuropathy were not clearly stated. Any dose adjustment for the chemotherapy regimen or oxaliplatin dose, treatment delay, or missed treatment were not mentioned or addressed.
• Other limitations/explanation: Both groups received calcium and magnesium supplementation that may have confounded results. The clinical effectiveness of vitamin E may not have been measured adequately. Dosing of vitamin E at 400 mg daily was based on only one previous clinical trial using cisplatin, not oxaliplatin. There may have been differences in peripheral neuropathy under the 50% measurement used that were not able to be evaluated.

This small pilot study showed no benefit of vitamin E in preventing or reducing the onset or grade of peripheral neuropathy with oxaliplatin-based regimens over 12 weeks. Patients receiving vitamin E had increased signs and symptoms of diarrhea. Further nursing research is needed to evaluate the therapeutic value of vitamin E in this setting.

To determine if the intervention used would increase adherence to ​National Comprehensive Cancer Network (NCCN), Multinational Association of Supportive Care in Cancer, and American Society of Clinical Oncology guidelines in patients receiving moderately emetogenic chemotherapy (MEC) for glioma

• N = 14 providers, 36 patients  
• AGE = Not provided
• MALES: 36%, FEMALES: 64%
• KEY DISEASE CHARACTERISTICS: Included six physicians and eight APNs who ordered antiemetics; all patients had glioma and were receiving at least moderately emetogenic chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Median clinical experience was 6.5 years with a range of 1–31 years. Providers were trained in neurology (n = 7) or oncology (n = 7).

• SITE: Single site    
• SETTING TYPE: Outpatient  
• LOCATION: Duke University Preston Robert Tisch Brain Tumor Center

• PHASE OF CARE: Active antitumor treatment

One-sample, binomial, quasi-experimental design measuring pre- and postintervention data for adherence and patient outcomes

• The retrieval of providers’ computerized prescriptive records and existing assessment tools was used to assess patient CINV rates and quality of life. The CINV complete response rate (CR) for both acute and delayed phases was defined as no emetic episode and no use of rescue medication. CINV CR was defined as no vomiting or use of medication for vomiting, and CINV CR as absence of need for medication for nausea.
• Osoba survey for quality of life
• Functional Assessment of Chronic Illness Therapy–Brain (FACIT–B)
• Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–F)
• Adherence was defined as the ratio of antiemetic orders with palonosetron and dexamethasone to total orders.

Providers used standardized order sets more often, which was associated with fewer patient reports of nausea and vomiting. Of 61 orders, adherence to guidelines was seen in 58%. Over time, adherence ultimately increased to 92%. There was a significant increase in acute (p < 0.05, 75% CR) and delayed (p < 0.05, 84% CR) CINV rates. Nausea was less controlled, and CR rates for nausea only improved by 3%–4%. No significant changes in quality of life were identified.

Patients with improved adherence also reported less nausea and vomiting and better quality of life.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Findings not generalizable
• Other limitations/explanation: There was no discrimination for duplicate data (same provider writing orders for same patients on multiple visits).

These findings supported the use of standardized order sets for all prescribers, including nurses, who order antiemetics for patients receiving chemotherapy within a single institution. It also supports using NCCN guidelines (specifically palonosetron and dexamethasone recommendations) for patients with malignant gliomas receiving moderately emetogenic chemotherapies.

To assess the efficacy and safety of fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving multiday cisplatin combination chemotherapy

Germ cell tumor patients receiving a five-day cisplatin combination chemotherapy were enrolled. Fosaprepitant 150 mg was given intravenously on days 3 and 5. A 5HT3 receptor antagonist was administered on days 1–2 (on days 1, 3, and 5, if palonosetron), plus 20 mg dexamethasone on days 1–2 and 4 mg twice a day on days 6–8. Patients were asked to keep a diary of the chemotherapy cycle on days 1–8.

• N = 54   
• MEDIAN AGE = 33 years
• MALES: 100%  
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Germ cell tumors
• OTHER KEY SAMPLE CHARACTERISTICS: Caucasian, mostly chemotherapy naïve, stage I–II

• SITE: Not stated/unknown   
• SETTING TYPE: Not specified    
• LOCATION: Not stated

PHASE OF CARE: Active antitumor treatment

• Single-arm, phase-II trial

• 100 mm visual analog scale (VAS)
• Acute phase CINV defined as days 1–5 and delayed phase defined as days 6–8

The primary objective was to determine the complete response (CR) rate as no emetic episodes or use of antiemetic medications. The CR was observed in 12 (24.1%) patients.

The reported CR rate was much lower than that generally reported, suggesting a much lower efficacy for CINV with a five-day cisplatin regimen.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable

Whether substituting fosaprepitant for aprepitant provides the same benefit in a multiday cisplatin regimen is unknown.

STUDY PURPOSE: To review the evidence for educational interventions in cancer-related pain management

TYPE OF STUDY: Systematic review

DATABASES USED: MEDLINE, EMBASE, CINAHL, and Cochrane collaboration

KEYWORDS: Cancer, education, and pain

INCLUSION CRITERIA: Systematic reviews that evaluated educational interventions for cancer pain management; participants were adult patients, caregivers, or health professionals

EXCLUSION CRITERIA: Studies including trials of cognitive behavioral therapy, mindfulness, relaxation, hypnosis, or acupuncture

TOTAL REFERENCES RETRIEVED: 2,066

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for quality assessment

• FINAL NUMBER STUDIES INCLUDED = 8
• TOTAL PATIENTS INCLUDED IN REVIEW = 18,544 (147 total studies)
• KEY SAMPLE CHARACTERISTICS: Not provided

APPLICATIONS: Palliative care

In the eight systematic reviews included, two reported that educational interventions had a positive impact on pain intensity. The rest did not report any effects on pain outcomes but concluded improved knowledge and adherence to pain medications. A detailed review of randomized, controlled trials included in the systematic reviews reported improved pain intensity outcomes in 12 studies and no significant difference from controls in 18 studies. Educational interventions had at least one of the following components: education on the physiology of cancer-related pain, advice on how to report and communicate pain, enhancements of provider assessments of pain, improved analgesic prescribing, approaches to barriers to nonadherence, nonpharmacologic strategies, or the promotion of pain reassessment.

Educational interventions for healthcare providers improved knowledge and attitudes, but their effects on patient pain outcomes were not demonstrated. Education for patients has shown inconsistent effects on pain outcomes. The key characteristics of effective educational interventions were not clear. Educational interventions for patients improved their knowledge and self-reported pain outcomes.

• The studies included had very different scope and approaches.
• The interventions were heterogeneous in approach, content, timing, and duration.

Evidence regarding the effectiveness of educational and psychoeducational interventions to reduce cancer-related pain outcomes showed mixed results. However, in some studies, education had a positive effect on pain intensity. These interventions improved knowledge. Educational interventions are low-risk and can empower patients to self-manage pain. Evidence in this review suggested that ongoing patient contact and reinforcement is needed to maintain any gains from educational interventions. The most effective components and method of education delivery are not clear. This area could benefit from additional research.