To study the effectiveness of psyllium fiber (Metamucil^®) taken during pelvic radiation treatment for prostate or gynecological cancer

The experimental group received 1–2 teaspoons psyllium fiber. The control group did not receive any psyllium fiber. Patients in both groups were given a booklet titled “Nutritional Guidelines to Help Control Diarrhea.” Patients kept diaries from day 1 of recruitment through 28 days post-treatment, recording the number of bowel movements per day, consistency of stools, amount of antidiarrhea medication taken, and daily dose of psyllium fiber (for the experimental group).

• The study reported on 84 patients (72 males and 12 females).
• Patients had prostate or gynecologic cancer and were undergoing radiotherapy to the pelvis of at least 4,000 cGy in 20 fractions. 
• Patients with gastrointestinal (GI) disease, tumors of the GI tract, or regularly using laxatives or antidiarrheal medications were excluded from the study.

This was a nonblinded, randomized controlled trial.

• Diarrhea was assessed using the Murphy Diarrhea Scale, which is a scale that has not yet been validated but is based on preexisting scales.
• A day with diarrhea was defined as any one of the following.
  • 4–6 bowel movements (BMs) more than normal limits for the patient
  • One or more watery BMs
  • 2-3 loose BMs more than normal limits for the patient
  • Use of antidiarrhea medications
• Severity rankings were as follows.
  • Mild: Less than 11% of days with diarrhea
  • Moderate: 11%–20% of days with diarrhea
  • Severe: More than 20% of days with diarrhea
• Researchers identified the mean severity score for diarrhea, incidence of diarrhea, mean time to onset of diarrhea, mean duration of diarrhea (in days), and the mean percentage of days in which patients took antidiarrhea medication.

• Psyllium fiber was effective in reducing the incidence and severity of radiation-induced diarrhea.
• A statistically significant difference was found in severity (p = 0.030) and incidence (p = 0.049) of diarrhea.
• No statistical difference was found in mean time to onset of diarrhea, duration of diarrhea, or percentage of days in which patients took antidiarrhea medications.
• Psyllium fiber was well-tolerated, and patients had no complaints of GI side effects.
• The cost of psyllium fiber is low.

Psyllium fiber is a well-tolerated, low-cost, effective intervention for reducing the incidence and severity of radiation-induced diarrhea in patients undergoing pelvic radiation treatment for prostate or gynecologic cancer. 

• Because this was a pilot study, it was limited in scope.
• The study had a high attrition rate (60 out of 84 patients completed the study, 30 in each group; patients with inaccurate or incomplete diaries and patients in the non-psyllium fiber group who used psyllium fiber were excluded from final analysis).
• Proctor and Gamble, manufacturer of Metamucil^®, provided partial funding for the study via a research grant.

To determine the effectiveness of palonosetron when compared to granisetron in controlling nausea and vomiting in people with gastrointestinal cancer who were receiving moderately emetogenic chemotherapy

Patients with gastrointestinal cancer receiving their initial dose of induction chemotherapy (moderately emetogenic) either received 3 mg of granisetron or 0.75 mg of palonosetron on day 1 of treatment in addition to standard treatment (6.6 mg IV dexamethasone on day 1 and 8 mg oral dexamethasone on days 2 and 3). Effectiveness of the antiemetics was evaluated on day 5 by comparing occurrence of acute and delayed nausea and vomiting between the two groups.

• N = 92  
• MEAN AGE (whole sample) = 67.25 years (range = 37–86 years) 
• MALES: 69.5%, FEMALES: 30.4%
• KEY DISEASE CHARACTERISTICS: Gastrointestinal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving moderately emetogenic chemotherapy

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Large cancer clinic in Japan

• PHASE OF CARE: Active antitumor treatment

Prospective observational design, no random assignment of conditions, and no blinding of conditions

The Multinational Association of Supportive Care in Cancer's (MASCC's) Antiemesis Tool (MAT) with additional items about anorexia added. The MAT contains eight items assessing acute and delayed nausea and vomiting and one item assessing anorexia. Participants were asked to complete this measure five days after receiving chemotherapy.

Overall nausea and delayed nausea were significantly lower in the palonosetron group as compared to the granisetron group (p  <  0.01). The differences between acute nausea, overall vomiting, delayed vomiting, and acute vomiting were not statistically significant.

Palonosetron effectively controls delayed nausea caused by moderately emetogenic chemotherapy as compared to granisetron in patients with gastrointestinal cancer.

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

Palonosetron appears to be effective in controlling delayed nausea and would be a useful antiemetic to prescribe for those receiving regimens consisting of moderately emetogenic chemotherapy.

The purpose of the study was to facilitate practice based on clinical evidence by establishing practice guidelines on the use of myeloid growth factors. Adults in hematology and oncology were studied.
 

The resource type was evidence-based guideline. The process of development included a review of the meta-analysis, systematic Cochrane review, and a review of several randomized clinical trials.

The Cochrane database was reviewed. Keywords included  neutropenia, febrile neutropenia, myeloid growth factors, G-CSF, clinical practice guidelines, filgrastim, and pegfilgrastim
 

Active antitumor treatment

This article did not discuss the specific evidence, but outlined benefits of treatment with colony-stimulating factor (CSF) and its use in chemotherapy regimens. Distinguished use as secondary or therapeutic and reviewed the different types of CSFs to be used with which tumor types. The volume of citations was 35.

The use of CSF for primary prophylaxis should be based on the risk of an episode of febrile neutropenia based on disease and chemotherapy regimen. Chemotherapy regimens with risk of febrile neutropenia greater than 20% of primary prophylaxis with CSF is recommended; 10%–20% febrile neutropenia CSF should be considered and less than 10% risk CSF is not recommended. Secondary prophylaxis following an episode of febrile neutropenia or dose-limiting neutropenia, CSF should be considered if not given previously or in cases in which a reduction or delay of the dose is associated with poor prognosis.  Therapeutic use when patients present with febrile neutropenia is recommended based on the existing risk factors for poor clinical outcomes or for developing infection-associated complications.

Risk factors are older than age 65 years, sepsis syndrome, severe neutropenia, absolute neutrophil count (ANC) less than 100 mcl or prolonged duration of more than 10 days, pneumonia, invasive fungal infection or other clinically documented infections, hospitalization at time of fever, and prior episode of febrile neutropenia.

Provides professional evidence-based guidelines for use of CSFs for prophylaxis and treatment of febrile neutropenia. Recommendations here are consistent with those of past versions, and are consistent with those of the National Comprehensive Cancer Network and other relevant professional groups.

To evaluate the efficacy of olanzapine in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving platinum-based chemotherapy and prophylactic palonosetron and dexamethasone

• N = 100   
• MEAN AGE = Control group: 55.04 years (SD = 1.5); test group: 53.66 years (SD = 1.55)
• MALES: 58%, FEMALES: 42%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Head and neck cancer, cervical cancer, esophageal cancer, ovarian cancer

• SITE: Single site   
• SETTING TYPE: Not specified
• LOCATION: Hospital in northwest India

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

This was a randomized, controlled, assessor-blind study.

Patients recorded the frequency and time of emetic episodes and the frequency and time of rescue antiemetics for the first five days. Patients also used the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) to record the control of nausea and vomiting and intensity of symptoms from days 1–5. Patients also recorded any adverse effects on days 1, 3, and 8–10 and as needed, as well as the duration and severity of the adverse effect. A trained nurse assessed all patients between day 8–10. At this time, the patients' overall quality of life was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30), version 3, questionnaire.

For patients receiving platinum-based chemotherapy, olanzapine is an effective addition for the prevention of CINV. The only side effect listed is more sedation.

Findings not generalizable

Olanazpine is effective for the prevention of CINV in this sample with few adverse effects. It may not be generalizable, but more studies are supporting its use.

To evaluate the effectiveness of sodium picosulfate for constipation.

Patients were randomized to receive either sodium picosulfate or matching placebo drops as treatment. If the study treatment was not effective, 10 mg bisacodyl was used as rescue medication. Patients were allowed to titrate the number of study drug drops to best meet their bowel function needs.

• The study reported on a sample of 202 women.
• Mean patient age was 50.8 years in the treatment group and 51.9 years in the placebo group.
• The sample comprised healthy patients with functional constipation.
• Mean duration of constipation was 13.2 years.

• Multi-site
• Outpatient
• 45 general practices in Germany

This was a double-blind, placebo-controlled, parallel-group, randomized clinical trial.

• Diary to record bowel symptoms
• SF-36^®, version 2
• Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
• Rome III diagnostic criteria

• The mean number of complete spontaneous bowel movements (BMs) increased from 0.9 to 3.4 in the sodium picosulfate group, compared to an increase from 1.1 to 1.7 in the placebo group (p < 0.0001).
• The mean number of complete spontaneous BMs per week compared to baseline increased by more than one in 65.5% of patients (p < 0.0001).
• After 24 hours, more patients in the intervention group had a complete spontaneous BM compared to the control group (69% versus 53%).

The use of laxative with sodium picosulfate in patients with chronic constipation may improve complete spontaneous BMs.

• The study was performed on a very general population. One should be cautious in interpreting these data for patients with cancer.
• The SF-36 looks at general functional status and is not a great tool for measuring quality of life.

Nurses need to be aware of other agents for the treatment of constipation, as well as the pharmacodynamics in which these agents work.

To describe one organization’s experience and findings with the use of prophylactic and interventional granulocyte infusions.

Two different approaches with granulocyte transfusions were used: (1) as an intervention for patients with progressive life-threatening infections and (2) to prevent the recurrence of infections in patients at high risk, including those undergoing allogeneic peripheral stem cell transplant. Patients receiving prophylactic treatment were scheduled for granulocyte transfusion from the beginning of neutropenia in the treatment cycle.  As an intervention, transfusions were given to patients with an absolute neutrophil count (ANC) less than 100/mm³ if they had a life-threatening infection despite other prophylactic antimicrobial treatment or severe infections during a previous neturopenic period, with a high risk of recurrence.  Timing and frequency of granulocyte transfusions were not described, but it was stated that transfusions were stopped if the ANC was greater than 500/mm³ 48 hours after the last transfusion.  Outcomes were evaluated 30 days after the first transfusion.

• Sixty-seven patients (79% male, 21% female) were included. 
• Median age was 56 years in the prophylactic group and 52 years in the interventional group (range 21–68).
• All patients had leukemia or non-Hodgkin lymphoma; 42% were undergoing transplant, 27% were receiving consolidation chemotherapy, and 24% were receiving salvage chemotherapy. Seventy-six percent of patients had a previous underlying fungal infection.

• Single site  
• Inpatient  
• Germany

Patients were undergoing the active antitumor treatment phase of care.

 This was a descriptive observational study.

European Organization for Research and Treatment of Cancer (EORTC) criteria for the classification of fungal infections

• Twelve percent of patients died with an inability to control infection.  
• In 82% of the treatment cycles, there was a positive response, and benefit seemed to be greater in the case of fungal infections, with prophylactic use (p = 0.01).
• Transfusions were reported to be well tolerated.

This study described the use of granulocyte transfusions and findings between prophylactic and interventional use related to fungal infections.

• Small sample (<100)
• Risk of bias (no control group, no blinding, no random assignment) 
• Unintended interventions or applicable interventions that would influence results were not described.*
• Selective outcomes reporting*
• Measurement/methods were not well described.

* Results reporting provides individual case details but little analysis of results and only analysis of difference between prophylactic use and interventional use in a small subset of patients who developed fungal infections.  There was no information regarding antifungal prophylaxis or other aspects of care that can be expected to affect these outcomes.  Reporting of percentages varied between the sample percent, cycles, or episodes of transfusion.  Many of the cases reported as fungal infection were actually possible rather than actual according to the EORTC criteria used. There was no subgroup analysis between various sample groups with different infection risks.

This study provided minimal information; it described an experience in using granulocyte transfusions.

To investigate the effects of prophylactic antihistamine on colony-stimulating factor(CSF)–related bone pain

The study included observation and treatment phases. Patients receiving pegfilgrastim completed pain surveys during the observation phase. Patients who developed significant pain were randomized to loratadine 10 mg daily or a matched placebo for seven days beginning on the day of pegfilgrastim administration. Rescue analgesics were recorded. Bone pain was assessed at baseline and on day 8 during both study phases.

• N = 213 in observation phase, 46 in treatment phase   
• MEDIAN AGE = 59 years
• AGE RANGE = 22–90 years
• MALES: 33.9% (observation), FEMALES: 66.1% (observation)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Various tumor types with breast and lung most common.
• OTHER KEY SAMPLE CHARACTERISTICS: All had baseline bone pain greater than or equal to 5 for study entry, and 25.7% were on non-NSAID analgesics at baseline.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: USA

• PHASE OF CARE: Active antitumor treatment

• Observation and double-blind randomized treatment trial

• Brief Pain Inventory (BPI)
• Functional Assessment of Cancer Therapy–Bone Pain (FACT-BP)

Significant bone pain occurred in 30.5% of patients and worst pain score increased on average from 1.6 to 3.6 during the eight days following pegfilgrastim (p < 0.001). Patients receiving taxanes were more likely to develop significant pain (50.8% versus 23%, p < 0.001). There were no significant differences in baseline pain scores or change in pain scores between study groups. There were no significant differences between groups in analgesic use. Among patients receiving taxane, 90% benefited from loratadine, compared to 27.3%  in the placebo arm (p = 0.0008). Both study groups receiving taxanes showed increased worst pains scores from baseline.

In the total sample, antihistamine prophylaxis did not demonstrate a benefit for prevention of CSF-induced bone pain. Findings suggest that there may be some effects for patients receiving taxanes; however, the sample size is too small to draw firm conclusions.

• Small sample (< 100)
• Measurements used were designed to measure chronic pain rather than the acute episodic pain associated with CSFs. Pain was measured only at two time points. Some data regarding analgesic use were missing.

This study did not show any benefit of antihistamine for prevention of CSF-related bone pain. Findings suggest that further research in this area is needed, and specific examination of any benefits in patients receiving taxanes should be further investigated.

Patients received 20 mL pure, natural honey 14 minutes before radiotherapy, then 20 mL 15 minutes and six hours after radiotherapy. Honey was rinsed and gradually swallowed to coat the oral and pharyngeal mucosa.

• N (honey group) = 20
• N (control group [20 mL NS]) = 20
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer received radiation to a total dose of 50–60 Gy.
   

• RCT
  • Single-blind (examiner only)

• Mucositis severity was scored each week of radiation by one clinician blinded to groups.
• Oral Mucositis Assessment Scale (OMAS)

OMAS scores were significantly lower for the honey group than the control group for all weeks (p = 0.000). Significant differences were noted during week six of therapy. Mean weight loss was significantly higher in the control group (p = 0.000).

• Small study

Bupropion sustained release (SR) was administered for four weeks at the maximum tolerated dose. Dosing was initiated at 100 mg in the morning and adjusted in increments of 50 mg, based on tolerability and effects, to a maximum of 300 mg daily. It was given in divided doses of either 100 or 150 mg. The dose was not increased if the maximum tolerable dose had been identified. The dose was 300 mg per day until the Brief Fatigue Inventory (BFI) score had dropped to less than 50% of the initial value. Following dose escalation, a four-week, fixed-dose phase occurred at the maximum tolerated dose, during which efficacy and safety measures were assessed every two weeks. The average dose for bupropion SR was 214 mg per day (standard deviation = 80 mg).

• The study included 21 patients (52% male) with a mean age of 40.4 years.
• All patients had persistent fatigue as a prominent symptom (scoring at least 4 out of 10 on the BFI fatigue interference scale). Nine patients scored 7 or greater on the BFI, which indicated severe fatigue.
• One-third of the patients had a primary brain tumor, and approximately 25% had breast cancer. Patients with brain tumors were overrepresented because the sample included a specific recruitment of this patient population.
• Patients were ineligible if they were receiving erythropoietin or had received it in the past six weeks, were using psychostimulants or antidepressants, or identified a medical cause for fatigue (e.g., thyroid dysfunction, adrenal insufficiency) on screening tests or on review of systems.

• Outpatient
• Large comprehensive cancer center

The study used a prospective, variable dose, open-label trial design.

• BFI scores were measured every two weeks and were used for dose escalation and then were measured twice for evaluation of treatment effects during the four-week, fixed-dose phase of the study.
• Other constructs measured included depression and health-related quality of life.

• A statistically significant improvement (p = 0.001) in fatigue was found when the baseline fatigue score was compared to the fatigue score obtained after four weeks of the fixed-dose treatment with bupropion.
• At baseline, fatigue and depression were not significantly correlated (r = 0.21).
• Four patients withdrew during treatment due to intolerable side effects (n = 1), perceived lack of efficacy (n = 2), and scheduled surgery for cholecystitis and cholelithiasis (n = 1).

• The trial was open-label and nonrandomized.
• The sample size was small, which made it difficult to establish a relationship between depression and fatigue.
• Overrepresentation of patients with brain tumors limited generalizability.
• The lengths of treatment and follow-up were brief.
• Side effects experienced at dose limits were not described; one patient withdrew because of side effects, but no details were reported.
• Cost was incurred to acquire the drug.

To determine the effect of n-acetyl cysteine (NAC) on the incidence and severity of oral mucositis glutathione peroxidase-1 activity

Patients were randomized to groups by a researcher not involved in the assessment of study outcomes. This same researcher also provided either the study drug or the placebo to the administrating nurse. Nurses were not blinded to the study groups, but treating physicians and those involved in the assessment of study data were blinded to the groups.

The study group was given NAC at 100 mg/kg of body weight diffused in 500 ml dextrose solution 5%. The drug was infused over a three-hour period beginning on the same day as high-dose chemotherapy (HDC) and continuing until 15 days post-transplantation. A placebo infusion was given to control subjects. Patients were assessed daily beginning the first day of HDC and continuing for 21 days post-transplantation or until mucositis resolved.

• N = 80
• AVERAGE AGE = 33.5 years
• MALES: 68.7%, FEMALES: 31.3%
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia 51.3%, acute lymphoblastic leukemia 43.8%, and myelodysplastic syndrome 4.9%

• SITE: Single-site

PHASE OF CARE: Active antitumor treatment

Double-blind, randomized, placebo-controlled study

• World Health Organization (WHO) Oral Toxicity Scale

The overall incidence of all grades of oral mucositis (OM) did not differ between groups. The incidence of severe OM (grades 3 and 4) was significantly lower in the intervention group (23.7%) compared to the control group (45.2%) (p = 0.04). No patients in the intervention group developed grade 4 mucositis while seven patients in the control group developed grade 4 mucositis. Patients who received NAC had a significantly shorter duration of mucositis (6.24 days) compared to controls (8.12 days) (p = 0.02). There was no difference in the time to onset of mucositis between groups. The use of parenteral opioid analgesics was not significantly different between study groups.

In this study, patients in the intervention group experienced less severe oral mucositis. No patients who received NAC developed grade 4 mucositis. Additionally, patients receiving NAC had a shorter duration of oral mucositis compared to controls. There was, however, no difference in the overall incidence of all grades of mucositis (grades 0–4) and no difference in the time to onset of mucositis between groups.

• Small sample (< 100)

NAC was shown to decrease the severity and duration of OM and was well tolerated by the patients in this study. Patients undergoing transplant can benefit from these findings as the toxicities of increased pain, potential for infection, impaired nutritional intake, and prolonged hospitalization can be decreased. Nurses should carefully asses patients for the presence of mucositis during treatment with HDC and continue assessments until mucositis has resolved.