Kitamura, H., Takahashi, A., Hotta, H., Kato, R., Kunishima, Y., Takei, F., . . . Sapporo Medical University Urologic Oncology Consortium. (2015). Palonosetron with aprepitant plus dexamethasone to prevent chemotherapy-induced nausea and vomiting during gemcitabine/cisplatin in urothelial cancer patients. International Journal of Urology, 22, 911–914.
To evaluate the antiemetic potential of palonosetron, aprepitant, and dexamethasone in patients with urothelial cancer receiving gemcitabine and cisplatin chemotherapy
Patients received one of two antiemetic regimens, ondansetron or granisetron plus dexamethasone, or palonosetron, aprepitant, and dexamethasone, and over one cycle of chemotherapy were evaluated for chemotherapy-induced nausea and vomiting (CINV) events, rescue medications needed, and food intake.
Patients in the palonosetron, aprepitant, and dexamethasone group had significantly fewer episodes of CINV, anorexia, and rescue medication used compared to the ondansetron or granisetron plus dexamethasone group during the first cycle of chemotherapy (p = 0.012) and overall during chemotherapy (p = 0.0019).
The use of palonosetron plus aprepitant and dexamethasone results in significantly fewer episodes of CINV, anorexia, and rescue medications used in people with urothelial cancer treated with gemcitabine and cisplatin as compared to another commonly used antiemetic regimen, ondansetron or granisetron plus dexamethasone.
Palonosetron, aprepitant, and dexamethasone may offer more relief from CINV in people being treated with gemcitabine and cisplatin chemotherapy.
Kissane, D.W., McKenzie, M., Bloch, S., Moskowitz, C., McKenzie, D.P., & O'Neill, I. (2006). Family focused grief therapy: A randomized, controlled trial in palliative care and bereavement. American Journal of Psychiatry, 163, 1208–1218.
To examine the efficacy of family focused grief therapy on psychosocial functioning in families of patients who are terminally ill
Patients and relatives in several palliative care centers and hospices were recruited for the study. Families were randomly assigned to receive the focused grief therapy or usual care stratified based on recruitment site. Usual care consisted of standard palliative care provided by homecare programs, which involved counseling when deemed clinically appropriate. Focused grief therapy was provided by qualified family therapists who had received standardized training in the intervention. Clinical supervision of the therapists was provided throughout the trial, and fidelity to the intervention was independently evaluated from review of audiotaped sessions. Family focused grief therapy typically included four to eight sessions of 90 minutes provided across 9–18 months. It included exploration of family cohesion, communication, and handling of conflict. Families were assigned to functional classes: dysfunctional (sullen or hostile) or intermediate. Data at baseline and follow-up at 6 and 13 months postbereavement were obtained from relatives by a research assistant.
A randomized controlled trial design was used.
Among all participants, those receiving the study intervention had significantly greater change in mean score of the Brief Symptom Inventory (BSI) (0.12, p = 0.02). BSI showed a nonsignificant improvement at 13 months in the intervention group than in the control group. Grief phenomena diminished similarly in both groups. There was no significant difference in social adjustment in both groups. There were no other significant differences between groups. Among family members who were most distressed, differences were greater, with 0.83 improvement in the BSI (p < 0.01), Beck Depression Inventory (p < 0.01), and the Bereavement Phenomenology Questionnaire (p = 0.05). In both the intervention and control groups, the general patterns of change in outcomes measures showed overall decline in symptoms over time. Families with intermediate functioning who received the intervention had a larger reduction in conflict level at six months than intermediate families in the control group (p = 0.03). Hostile families that received the intervention deteriorated more than hostile control families over the 13 months of bereavement (p = 0.001). Intermediate families received an average of 7 sessions, sullen families received an average of 6.4 sessions, and hostile families received an average of 9.4 sessions.
Family focused grief therapy appeared to have some benefit for the most distressed family members in terms of reduction of symptoms; however, these changes were not accompanied by improvement in family functioning. This intervention may protect against pathologic grief in highly distressed individuals. Among hostile families, the intervention was counterproductive
Family focused interventions to mitigate grief issues may be helpful in some families for highly distressed individuals; however, among the most dysfunctional families, this type of intervention might be counterproductive. Additional research is needed to determine the appropriate role of this therapy approach in palliative care.
Kissane, D.W., Bloch, S., Smith, G.C., Miach, P., Clarke, D.M., Ikin, J., . . . McKenzie, D. (2003). Cognitive-existential group psychotherapy for women with primary breast cancer: A randomized controlled trial. Psycho-Oncology, 12, 532–546.
The intervention was cognitive-existential therapy (CEGT) provided in nine Australian hospitals. Existential themes of anxiety about death and uncertainty were incorporated into six goals of therapy: promoting a supportive environment, facilitating grief work over multiple losses, altering maladaptive cognitive patterns, enhancing problem-solving and coping skills, fostering a sense of mastery, and sorting out priorities for the future. The CEGT group had 20 weekly sessions, 90 minutes each, over six months. The control group had three 50-minute relaxation classes using progressive muscle relaxation with guided imagery. Measurements were taken at baseline, 6 months, and 12 months after the intervention. The intervention was offered by 15 therapists recruited from psychiatry, psychology, social work, occupational therapy, and oncology nursing staff. All therapists received specialized training and supervision through a series of workshops using 68-page manual.
Nine Australian hospitals
A randomized controlled trial/longitudinal study design was used.
Kirshner, J.J., Heckler, C.E., Janelsins, M.C., Dakhil, S.R., Hopkins, J.O., Coles, C., & Morrow, G.R. (2012). Prevention of pegfilgrastim-induced bone pain: A phase III double-blind placebo-controlled randomized clinical trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base. Journal of Clinical Oncology, 30, 1974–1979.
To determine whether naproxen could prevent or decrease the incidence and/or severity of pegfilgrastim-induced bone pain
A baseline assessment questionnaire was administered prior to treatment asking the presence, location, and duration of bone or joint pain, as well as how the pain was treated. A second set of questions asking whether there was development of new bone or joint pain, location, onset, duration, and severity of the effect of the assigned medication was given to patients at the time of pegfilgrastim administration. Any additional analgesia taken by the patient was also recorded. Questionnaires were completed at home and mailed. Patients were telephoned at home as a reminder to mail in their questionnaires. Enrolled patients received 500 mg of naproxen PO or placebo instructed to take prior to pegfilgrastim and continue BID. Patients were then asked to record pain severity on a 0–10 scale and duration in a daily diary. Serious adverse events (SAEs) were reported to local investigators at the University of Rochester Cancer Center Community Clinical Oncology Program research base. Other symptoms were recorded but not reportable (e.g., sleep disturbance, pain other than bone pain, fatigue).
The study was a phase III, double-blind, placebo-controlled, randomized trial.
African Americans experienced more bone pain than white patients. The naproxen group showed improvement in pain reduction versus placebo. Area under the curve for pain was 7.71 for the placebo group and 6.04 for the naproxen group (p = 0.037). Naproxen decreased maximum pain from 3.40 to 2.50 (p = 0.005), incidence from 71.3% to 61.1% (p = 0.020), duration from 2.40 to 1.92 (p = 0.009), and severe pain from 27% to 19.2% (p = 0.048). Bone pain reached maximum at day 3, where naproxen patients experienced the most benefit. Patients receiving naproxen took less prescription and nonprescription pain medication. Six SAEs occurred in the naproxen group, and six SEAs occurred in the placebo group, with all SAEs unlikely or determined to be unrelated to the intervention.
There is a high incidence of pain in patients receiving pegfilgrastim. Naproxen seems to decrease incidence, duration, and severity.
The pain questionnaire was not presented in the article, and further studies may not reproduce similar results. Patients were called at home to complete the survey; prescription and nonprescription medications that were taken in addition to the naproxen and timing of the survey may have impacted results. It is also possible that the individual responding to the call may not have been the study participant. The study does not address whether individuals with other existing pain conditions were in the study or excluded or whether there were other pain conditions present at the start of the study that may have impacted results.
This study indicates there a is a difference in pain experience with different races, which may impact practice in terms of treating pain and the patient population being treated. Additional research and education are needed to investigate this difference. These results may be helpful in treating some patients’ pain; however, more work is needed to find treatments for those who cannot seek this treatment or who derive limited or no benefit from it. More than 60% of patients in this study still experienced pain, with approximately 20% experiencing severe pain. It seems this study has a good start to recognizing the existence of pegfilgrastim-induced pain and has tested a somewhat helpful intervention. However, there is still a need for more studies with different approaches to pain control and factors to predict incidence, severity, and ability to prevent pegfilgrastim-induced bone pain. The benefit of using naproxen is that it is low cost and has very few SAEs, which will need to be considered in future studies.
Kirova, Y. M., Fromantin, I., De Rycke, Y., Fourquet, A., Morvan, E., Padiglione, S., . . . Bollet, M. A. (2011). Can we decrease the skin reaction in breast cancer patients using hyaluronic acid during radiation therapy? Results of phase III randomised trial. Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology, 100(2), 205–209.
To evaluate the benefit of hyaluronic acid in management of radiodermatitis
Women who developed a grade 1 dermatitis with radiotherapy were randomized to use either hyaluronic acid cream or a simple urea-based emollient once daily. Patients were advised to shower one-to-two times daily. Clinical evaluation of the skin was done weekly by the radiation oncologist. Pain and quality of life were assessed at the end of treatment on day 30. The study endpoint was a success as defined by disappearance of erythema 30 days after its occurrence.
The study used a randomised open-label phase III design.
Overall, 36.5% of participants withdrew prematurely because of worsening of eipthelitis, patient refusal, change in treatment, or use of another product. In the intent to treat population (all registered), there was a 27.3% treatment failure with hyaluronate and a 38.8% treatment failure with emollient. Power analysis showed that 100 per study group were needed. With drop outs, this study was underpowered.
The study did not demonstrate any significant differences in epithelitis between those using hyaluronic acid or emollient topically. The study was insufficiently powered to provide any firm conclusions.
Study findings are inconclusive because of the study limitations. Findings suggest that hyaluronic acid and urea-based emollients topically may provide similar results for prevention of low-grade radiodermatitis. These findings should be viewed with caution because of the study design limitations and lack of sufficient sample size to meet power requirements.
King, K. (2010). A review of the effects of guided imagery on cancer patients with pain. Complementary Health Practice Review, 15, 98–107.
To review the effects of guided imagery on patients with cancer experiencing pain
The type of report was systematic review.
Databases searched were PubMed, CINAHL, PsycINFO, and Cochrane Library.
Search keywords were guided imagery, cancer pain, and systematic review.
Studies were included if they were review articles published in English since 1985; the search was not limited to randomized controlled trials (RCTs).
Studies were excluded if they were clinical trials or systematic reviews that did not utilize guided imagery as an intervention, did not specifically investigate cancer pain, were not a clinical study but rather a summary of guided imagery, had a qualitative design, and were not conducted within the study time frame.
In order to focus on the most current research, this review targeted articles published during 2001–2008.
Five studies included pain as either a primary or secondary outcome measure. In three of those, pain intensity and pain-related distress decreased in the guided imagery intervention versus control for pain intensity and pain-related distress, average pain score decreased, and there was a decrease in body discomfort.
It is difficult to give concrete recommendations that guided imagery will work for all patients who suffer from cancer pain. However, based on the information from these reviews, guided imagery can be recommended as a potential aid in the relief of pain associated with cancer.
Inconsistencies and limitations included the small sample size, different patient populations, different scripts, and frequency of medication administration.
There is inconsistency in the methodological qualities of these trials. Further research is necessary to provide better evidence for the use of guided imagery in cancer pain.
King, M., Deveaux, A., White, H., & Rayson, D. (2012). Compression garments versus compression bandaging in decongestive lymphatic therapy for breast cancer-related lymphedema: A randomized controlled trial. Supportive Care in Cancer, 20, 1031–1036.
To compare effects of compression garment versus compression bandaging in women receiving complete decongestive therapy for arm lymphedema
Therapy for all patients included manual lymphatic drainage five days per week over a two-week period. During initial treatment, patients were randomly assigned to wear a compression glove and sleeve or compression bandages day and night as tolerated. At the end of two weeks, all were provided with a new sleeve and glove, which was worn only during the day. They were instructed in skin care. Participants completed study measurement of lymphedema at baseline and on days 5 and 10 and then at 3 months.
There were no difference between groups in arm volume or DASH scores at 10 week or 3 months. There were no differences between groups in VAS symptom scores. There was a trend toward lower arm volumes but higher DASH scores with compression bandaging.
Findings showed no significant differences in effect of compression bandaging versus use of compression garments during the first two weeks of therapy for arm lymphedema.
Findings suggest that compression garment and compression bandaging use during initial phase of CDT for arm lymphedema yielded similar results. There was a trend suggesting lower arm volume, but higher disability scores with bandaging; however, no firm conclusions can be drawn due to lack of statistical significance and the small sample size. Ongoing work is important to determine which treatment approaches are better tolerated by patients and degree of comparative effectiveness combined with tolerance.
Kim, S.Y., Song, J.W., Park, B., Park, S., An, Y.J., & Shim, Y.H. (2011). Pregabalin reduces post-operative pain after mastectomy: A double-blind, randomized, placebo-controlled study. Acta Anaesthesiologica Scandinavica, 55(3), 290–296.
To investigate the safety and effectiveness of pregabalin for reducing postoperative pain in patients who have undergone mastectomy
Patients were randomly assigned to receive either pregabalin or placebo at 1 hour before surgery and at 12 hours after the initial dose. All patients received the same anesthesia and all received 100 mg aceclofenac twice a day the day after surgery. Assessment of pain and for adverse effects was done at 1, 6, 24, and 48 hours postoperatively. If a patient’s pain intensity was 5 or greater or if the patient requested analgesia, additional pain medication was provided. After discharge from the hospital, at one week and one month postoperatively, patients were contacted by phone for pain scoring.
Double-blind placebo-controlled randomized study
Perioperative pregabalin may improve postoperative pain control in patients who have undergone mastectomy.
Perioperative administration of pregabalin may be helpful in the management of postoperative pain. This study does not establish the most effective timing of administration. Nurses should be aware of the common side effects of pregabalin (dizziness and sedation), which other studies have established. These side effects may complicate postanesthesia assessment.
Kim, S. W., Shin, I. S., Kim, J. M., Kim, Y. C., Kim, K. S., Kim, K. M., . . . Yoon, J. S. (2008). Effectiveness of mirtazapine for nausea and insomnia in cancer patients with depression. Psychiatry and Clinical Neurosciences, 62, 75–83.
To study the effectiveness of mirtazapine on various cancer-related symptoms, such as nausea, sleep disturbance, pain, and depression.
Patients were treated at a starting dosage of 15 mg of mirtazapine in orally disintegrating tablets a day. The dosage was titrated between 15 and 45 mg per day based on clinical judgment. Mean treatment dosage was 19.6 mg per day in the total population and 22.9 mg in those who completed the study. Patients were administered serial assessments at baseline and on days 1, 3, 5, 7, 14, and 28.
The study used a prospective, open-label, repeated measure design.
Nausea improved significantly from day 1 after administration of mirtazapine (p < 0.001). Improvement was sustained throughout the treatment and seemed to work best for patients actively receiving chemotherapy. In addition, anorexia improved. All sleep measures improved, many as early as day 1, but at least one measure (ease of wakening) did not improve until day 5 (p < 0.001). Mirtazapine increased sleepiness in one of three patients, but this resolved after several days on therapy. Reduction in pain scores (p < 0.5), improvement in depression score (p < 0.01), and overall quality of life (QOL) (p < 0.01) were noted as well.
Mirtazapine may be helpful in treating the cancer-related symptoms of nausea, sleep disturbance, anorexia, pain, and depression, as well as improving QOL.
Mirtazapine may be useful in treating chemotherapy-related symptoms, especially sleep disturbance and nausea, in patients with malignant cancers.