Ryu, J.K., Swann, S., LeVeque, F., Scarantino, C.W., Johnson, D., Chen, A., et al. (2007). The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. International Journal of Radiation Oncology, Biology, Physics, 67(3), 643–650.
Subcutaneous GM-CSF (250 mcg/m2) was started one week before radiation and stopped two weeks after completion. GM-CSF was given within two hours after each radiation fraction on Monday, Wednesday, and Friday. Doses were held on days that patients received chemotherapy.
Patients with head and neck cancer with radiation ports on 50% or more of oral cavity or oropharynx to 60-70 Gy.
GM-CSF: n = 63
Placebo: n = 58
October 2000-September 2002
No statistical differences in mucositis or QOL scores
Some participants discontinued study because of unspecified “toxicity”. Drug supply ended before all patients completed therapy.
Ryan, J.L., Heckler, C.E., Roscoe, J.A., Dakhil, S.R., Kirshner, J., Flynn, P.J., … Morrow, G.R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20, 1479-1489.
To determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea (CIN) on day one of chemotherapy
Patients were randomly assigned to four arms.
Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT3 receptor antagonist antiemetic on day one of all cycles. Patients took three capsules of ginger (250 mg) or placebo twice daily for six days starting three days before the first day of chemotherapy. Patients reported the severity of nausea for days 1–4 of each cycle, four times daily. Compliance was determined by pill counts.
This was a multisite study conducted at 23 private practice oncology groups affiliated with the University of Rochester.
This was a phase II/III randomized, double blind, placebo-controlled clinical trial.
Ginger given at 0.5 g-1.0 g daily, may aid in the reduction of acute-phase CIN in patients receiving standard antiemetics. The ability to clearly interpret results is difficult because of lack of information on chemotherapy agents involved and differences in antiemetic regimens used.
This study showed that ginger significantly reduced nausea in these patients during the acute phase but had no apparent effect on delayed nausea. Studies in the use of ginger have had mixed results, and meta analysis have shown no effect, in contrast to this study. Here, only nausea was examined, which may partially explain differences. Application of these findings is difficult, because the chemotherapy regimens used are not described, so emetogenicity or differences in regimens between groups cannot be evaluated. Also, the antiemetic medications used were varied and subgroup analysis was not done; how this influenced findings is not clear. Even with maximum current pharmacologic management of chemotherapy-induced nausea and vomiting, control of nausea, as opposed to vomiting, has remained problematic. Further research in approaches to effectively manage nausea, as well as emesis is needed.
Rutkowski, A., Zajac, L., Pietrzak, L., Bednarczyk, M., Byszek, A., Oledzki, J., . . . Chwalinski, M. (2014). Surgical site infections following short-term radiotherapy and total mesorectal excision: Results of a randomized study examining the role of gentamicin collagen implant in rectal cancer surgery. Techniques in Coloproctology, 18, 921–928.
To determine the risk of surgical site infection (SSI) reduction using local gentamicin collagen implants (GCIs) following preoperative radiotherapy and total mesorectal excisions (TMEs)
No statistically significant differences existed between the study and control groups in early postoperative complications (25.6% and 34.1%, respectively, p = 0.245). The reoperation rate was similar in both groups: 12.8% versus 9.4%, p = 0.628, risk ratio [RR] = 1.359, 95% confidence interval [CI] [0.575, 3.212]. The total rate of SSI and organ space SSI were 22.2% and 15.8% without differences between the study and control groups. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received the GCI: 2.6% versus 13%, p = 0.018.
Inconclusive: Applying the GCI in the pelvic cavity after short-term preoperative XRT and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.
Postoperative complications were a secondary aim and, therefore, the study lacked adequate power. Fewer patients received GCI because of a protocol deviation. Organ space SSI was not confirmed by bacteriological swabs. Sometimes, SSI was determined by a CT or physical symptoms and, therefore, could be misconstrued as infection when it was really an inflammatory reaction. This suggests that anastomotic leakage is such a significant risk factor for organ space SSI that the application of GCI does not prevent it. Patients were not given preoperative antibiotics, which is a current standard of care.
Nursing implications for this are clearly good surgical patient care postoperatively, such as using the aseptic technique while changing dressings; encouraging walking to prevent pneumonia; and teaching good nutrition for healing and excellent handwashing. The actual test depends on the surgeon’s suturing and excising techniques to prevent leakage. This study did not provide strong evidence for the use of CGIs to prevent SSIs.
Rustøen, T., Valeberg, B.T., Kolstad, E., Wist, E., Paul, S., & Miaskowski, C. (2014). A randomized clinical trial of the efficacy of a self-care intervention to improve cancer pain management. Cancer Nursing, 37, 34–43.
To evaluate the efficacy of a psychoeducational nursing intervention for pain management on pain outcomes
Patients were randomly assigned to control or intervention groups. The intervention was a version of the PRO-SELF pain control program adapted from the work of Miaskowski et al. A specially trained oncology nurse visited patients in their homes on weeks 1, 3, and 6, and did telephone interviews on weeks 2, 4, and 5. Individual patient knowledge deficits were identified based on responses on the pain experience scale, and educational information was tailored to meet individual needs. Patients were given written instructions about pain and the management of adverse effects, and they were taught how to use a weekly pill box and how to use a script to communicate with their physicians about unrelieved pain. During telephone contact, education was reinforced and patients were coached about how to modify pain management or contact the physician to improve pain outcomes. Home visits also involved additional coaching and ongoing education. Patients in the control group were given a booklet about cancer-related pain management and received home visits and telephone interviews with the same timing, focusing on encouraging patients to maintain a pain diary. Pain assessments were done during telephone interviews. The principal investigator listened to tapes of the intervention and control group nurses to ensure the fidelity of the intervention and control conditions.
Randomized, controlled trial with attention control
There was a significant reduction in least, worst, and average pain in both groups. There were no differences based on group or the combinations of group and time. For both groups, there were significant decreases over time in total doses of opioids taken and no differences between groups in dosage changes. There were no differences between the groups in adjuvant pain medication use or other relevant interventions such as bone-modifying agents.
As used here, the psychoeducational nursing intervention to increase self-care in pain management did not have an impact on pain outcomes. It is not clear if the intervention changed patient behavior in pain management, though both groups in the study had some reduction in pain intensity.
The psychoeducational intervention used here improved patients’ knowledge about pain management, but it was not clear if it resulted in any behavior change, and there were no differences in pain outcomes between those who received the full intervention and those who were given attention and written instructions for pain control. More evidence is needed to determine the most effective components of this type of intervention. These findings also suggest that the provision of written directions for pain control, daily patient attention via diary use, and simple nursing attention may be as effective as more structured interventions.
Rustøen, T., Valeberg, B.T., Kolstad, E., Wist, E., Paul, S., & Miaskowski, C. (2012). The Pro-Self© Pain Control Program improves patients' knowledge of cancer pain management. Journal of Pain and Symptom Management, 44, 321–330.
To evaluate the effects of a psychoeducational intervention on increasing patients’ knowledge and attitudes of cancer pain management
Prior to the intervention, nurses were trained by the PI and study oncologist. The PI listened to audio recordings of the sessions with nurses and patients in the intervention and control groups to ensure fidelity. The Norwegian version of the Pro-Self Pain Control Program intervention was used. A trained oncology nurse made home visits at 1, 3, and 6 weeks and telephone interviews at 2, 4, and 5 weeks. At the week 1 visit, the nurse delivered educational information tailored to each patient’s needs and patients received written instructions about pain and side effect management and were taught how to use a pillbox and how to use a script to help discuss pain management with their physician. At weeks 2, 4, and 5, the intervention group was contacted via phone to review pain score and medication use. The consent of the Pro-Self Pain Control Program was reinforced, and patients received coaching on how to address pain management needs. The same was done for home visits on weeks 3 and 6. The control group was given a booklet about cancer pain management and received home visits and telephone calls on the same schedule as intervention patients. The focus of interaction in the control group was adherence with completing the study diary. Both groups recorded measurements in a pain diary every night.
At baseline, control patients reported a higher KPS score than those in the intervention group (p = 0.0003). Improvement in all individual and overall (p < 0.001) scores on the PES was noted for patients in the Pro-Self group. A statistically significant improvement was seen in nine items on the PES scale for patients in the intervention group.
The study resulted in an increase in knowledge of cancer pain management in the Pro-Self group.
Additional research is recommended to examine the influence of the level of education of participants on interventions to improve cancer pain management. A similar study was completed in the United States using a similar intervention, but the results were not as dramatic (the U.S. study yielded significant improvements in only five of the nine items on the PES, versus significant improvements in all 9 areas in the Norwegian study), which suggests cultural, educational, and demographic influences. Although individualized patient education tends to be more effective, this requires additional time and resources for planning and intervention.
Ruschulte, H., Franke, M., Gastmeier, P., Zenz, S., Mahr, K.H., Buchholz, S., . . . Piepenbrock, S. (2009). Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: A randomized controlled trial. Annals of Hematology, 88, 267–272.
To evaluate the effectiveness of chlorhexidine sponges in prevention of central venous catheter infections inserted for cancer chemotherapy
All patients received chlorhexidine and silver-impregnated, triple-lumen central venous catheters (CVC) that were intended for at least five-day use. Catheter insertion was done using maximal barriers, and skin antisepsis was done with alcohol. Catheter dressings were changed weekly. Patients expected to have catheters in place for less than five days were not included in the study.
Mean catheter duration was 15.8 days among controls and 16.6 days in the experimental group. Among the treatment group were 19 cases of CVC infection (3.8 per 1,000 catheter days) compared to 34 cases (7 per 1,000 catheter days) in the control group (p = 0.016).
The use of chlorhexidine-impregnated dressings was associated with a lower rate of catheter-related infections.
This study demonstrated supportive evidence for efficacy of chlorhexidine-impregnated dressings in CVC care to reduce the incidence of catheter-related infections. Patients with hematologic cancers receiving chemotherapy as included here are generally at high risk for infection. Interventions that can reduce the risk of infection in this patient population are important to incorporate into practice.
Rummans, T.A., Clark, M.M., Sloan, J.A., Frost, M.H., Bostwick, J.M., Atherton, P.J., . . . Hanson, J. (2006). Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: A randomized controlled trial. Journal of Clinical Oncology, 24, 635–642.
Intervention consisted of structured sessions, which began with 20 minutes of conditioning exercises conducted by a physical therapist followed by an educational session with cognitive-behavioral strategies for coping with cancer and open discussion with group leaders and other participants. Sessions were balanced with didactic material, a question and answer period, sharing, reflecting, relaxation, and physical activity. Participants attended eight sessions throughout four weeks following enrollment . Intervention was delivered three days per week. After the fourth week, patients filled out quality of life questionnaires, and questionnaires were collected at 8 and 27 weeks after enrollment via mail.
Mean score for fatigue scale of the LASA was lower at week four for the intervention group in comparison to the standard care group, but this difference was not significant. No significant differences were observed between groups for the SDS and FACT measures of fatigue at week four. Although intervention may have impact on overall quality of life, no significant effects were observed on fatigue.
Ruiz-Tovar, J., Santos, J., Arroyo, A., Llavero, C., Armananzas, L., Lopez-Delgado, A., . . . Calpena, R. (2012). Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. Journal of the American College of Surgeons, 214, 202–207.
The purpose of the study was to evaluate the effects of peritoneal lavage with normal saline or an antibiotic solution (clindamycin-gentamicin) on intra-abdominal abscesses and wound infection and to determine the microbiologic impact of both irrigations on peritoneal contamination.
An open surgical approach was used in all patients. The patients were randomized by means of an Internet randomization module into two groups: those undergoing an intra-abdominal lavage with normal saline (group 1) and those first undergoing an intra-abdominal lavage with normal saline followed by a second lavage with a clindamycin-gentamicin solution (group 2). Perioperative systemic antibiotics (ciprofloxacin 400 mg and metronidazole 1,500 mg; single-dose preoperatively, within 30 minutes of incision, and re-dosed after four hours when the surgery is prolonged over that time) were used in both groups. No mechanical bowel preparation took place in any patient.
A single-site inpatient setting (the coloproctology unit of the General University Hospital of Elche)
Active treatment
Prospective, randomized, placebo-controlled study
Wound infection rates were 14% in group 1 and 4% in group 2 (p = 0.009). Intra-abdominal abscess rates were 6% in group 1 and 0% in group 2 (p = 0.014).
In this study, antibiotic lavage was shown to be very effective, reducing the rate of positive culture by 59% after saline lavage to 4% after antibiotic lavage. These data show that, if the peritoneal cavity remains sterile, there is a lower risk of bacteria migrating from the abdominal cavity through the fascia to the subcutaneous tissue. The study also showed reduced intra-abdominal abscess rates.
A lower incidence of infection was noted in patients with antibiotic lavage during contaminated bowel surgery.
Findings would not be generalizable to other groups of patients.
Findings suggest that antibiotic intra-abdominal lavage may reduce surgical infectious complications in patients undergoing bowel surgery.
Ruiz Garcia, V., Lopez-Briz, E., Carbonell Sanchis, R., Gonzalvez Perales, J.L., & Bort-Marti, S. (2013). Megestrol acetate for treatment of anorexia-cachexia syndrome. Cochrane Database of Systematic Reviews, 3, CD004310.
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews
KEYWORDS: Extensive keyword and specific search term listing per database is provided.
INCLUSION CRITERIA: Studies were included if they were a randomized controlled trial; reported on patients with weight loss and anorexia-cachexia syndrome due to cancer, HIV, or other disease; and studied use of megestrol acetate (MA) compared to placebo, to active control, or at different doses.
TOTAL REFERENCES RETRIEVED: N = 950 articles
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Quality and risk of bias were evaluated according to the Cochrane handbook criteria.
FINAL NUMBER STUDIES INCLUDED: N (studies) = 35 studies: 23 trials in cancer, with 3,428 patients
KEY SAMPLE CHARACTERISTICS: Patients with lung, gastrointestinal, head and neck, and gynecologic cancer, as well as unspecified cancer types, were included in the studies.
Patients receiving MA had weight gain (RR = 1.55, 95% CI 1.06–2.66) among trials in patients with cancer. Appetite improved with MA in patients with cancer (RR = 2.57, 95% CI 1.48–4.49). In studies where MA was compared to another active drug, such as a steroid or an antidepressant, in patients with cancer, there was no significant advantage with MA in meta-analysis. There was no apparent impact of higher doses of MA on appetite. There were more adverse events with MA than with placebo, with the most common adverse events being edema and thromboembolism. The quality of evidence for findings related to appetite and weight gain were deemed to be very low, mainly due to high risk of bias.
Findings suggest that MA is effective in improving appetite and resulting in weight gain among patients with cancer; however, findings also show that the quality of evidence was very low. MA did not appear to be more effective than other medications such as steroids.
The quality of evidence was very low.
MA can be effective in improving appetite and weight gain in patients with cancer. Higher doses of MA do not appear to have any greater effect. Nurses should be aware of the possible adverse events associated with MA use, such as thromboembolism. Further research in comparison of risks and benefits of MA in comparison to other medications and strategies to improve appetite and weight gain would be useful.
Ruhlmann, C.H., Christensen, T.B., Dohn, L.H., Paludan, M., Ronnengart, E., Halekoh, U., . . . Herrstedt, J. (2016). Efficacy and safety of fosaprepitant for the prevention of nausea and emesis during 5 weeks of chemoradiotherapy for cervical cancer (the GAND-emesis study): A multinational, randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Oncology, 17, 509–518.
To investigate the efficacy and safety of fosaprepitant in combination with palonosetron and dexamethasone in the prevention of nausea and vomiting during five weeks of fractionated radiotherapy and concomitant weekly cisplatin in patients with cervical cancer
Patients received fractionated radiotherapy and concomitant weekly cisplatin 40 mg/m2 for five weeks. Patients were randomly assigned to receive either single doses of 150 mg fosaprepitant IV or placebo (saline) in combination with 0.25 mg palonosetron IV and 16 mg dexamethasone orally before cisplatin administration. All patients received 8 mg dexamethasone orally twice a day on day 2, 4 mg twice a day on day 3, and 4 mg once a day on day 4. The treatment was repeated for five weeks. Patients kept daily logs of their symptoms, which were reviewed weekly to determine continued eligibility.
Of the patients, 48.7% of the placebo group and 65.7% of the control group with fosaprepitant sustained no emesis at five weeks. A significantly lower cumulative risk of emesis was seen in the fosaprepitant group compared to the placebo group (p + 0.008).
Patients receiving concomitant chemo/radiation therapy for cervical cancer who received fosaprepitant in addition to palonosetron and dexamethasone were less likely to experience emesis and nausea compared to those receiving palonosetron and dexamethasone alone.
Neurokinin 1 receptor antagonists (NK1s) use should be considered in the prevention of radiation-induced nausea and vomiting.