Milone, G., Leotta, S., Cupri, A., Fauci, A. L., Spina, P., Parisi, M., . . . Tripepi, G. (2014). Palifermin reduces infection rate and hyperfibrinogenemia in patients treated with high-dose chemotherapy based on beam or BU-thiothepa. Bone Marrow Transplantation, 49, 1193–1197.
To assess the effect of palifermin on mucositis and infection risk according to conditioning regimen used, and to evaluate the effect of palifermin on fibrinogen levels
This is a retrospective study of patients who underwent high-dose chemotherapy and autologous hematopoietic stem cell transplantation (auto-SCT) because of hematologic malignancies. The authors evaluated the differences between a cohort of patients who received prophylaxis with palifermin and a matched control group of patients who did not receive this agent, and assessed the effect of palifermin on infection risk according to the conditioning regimen used, comparing BEAM, BU-CY, THIO-CY, and HD-PAM conditioning regimens.
Total of 120 patients who underwent SCT from 2000–2009 who either received palifermin prophylaxis or did not receive palifermin (control group)
Weekly blood cultures, serum galactomannan assay, and skin and oral culture swabs were used in afebrile patients. Standard febrile workup was used including blood and urine cultures, chest radiography (CXR), and a CT of the thorax within 72 hours of the onset of fever. Any infection arising during the first 30 days was evaluated. Fever of unknown origin (FUO), pneumonia, febrile gram-positive bacteremia, and CVC-related infections were all evaluated. Mucositis was assessed for all patients using daily inspection and grading according to daily mucositis scoring using Eastern Cooperative Oncology Group (ECOG) Common Terminology Criteria for Adverse Events (CTCAE) criteria. Gastrointestinal (GI) toxicity was deemed as severe if there were five or more stools per day.
Palifermin reduced rates of severe mucositis when evaluation was conducted taking into account conditioning type. There was a significant reduction in the severe mucositis rate in the BEAM/BUS group, whereas there was no significant reduction in the HD-PAM group. Palifermin had no effect on GI toxicity. FUO was significantly reduced in palifermin treated group. A reduction in severe infections (p = 0.06) existed in the BEAM/BUS group. A highly significant reduction in gram-positive infections existed in the BEAM/BUS group but not in HD-PAM group. Rate of patients with fevers was decreased in the palifermin group, but not significantly. A reduction in serum fibrinogen peak levels during the aplastic phase was observed with palifermin in the BEAM/BUS group but not in HD-PAM group.
Palifermin reduced FUO and severe infections unrelated to gram-positive bacteria with a more evident effect after conditioning based on BEAM/BUS. Severe mucositis was also reduced in the BEAM/BUS group but not in the HD-PAM group. The reduction in fibrinogen level substantiates the beneficial effect and may suggest a reduction in risk of mortality.
Nurses should monitor fever, mucositis, and onset of infection; educate patients on infection prevention and use of medications; and advocate for use of palifermin in high-risk populations, including the elderly, those receiving BEAM/BUS therapy, or heavily pretreated patients.
Miller, C.L., Colwell, A.S., Horick, N., Skolny, M.N., Jammallo, L.S., O'Toole, J.A., . . . Taghian, A.G. (2016). Immediate implant reconstruction is associated with a reduced risk of lymphedema compared to mastectomy alone: A prospective cohort study. Annals of Surgery, 263, 399–405.
To determine the risk of lymphedema associated with immediate breast reconstruction compared to mastectomy alone
Patients were screened for lymphedema prospectively, and lymphedema rates were compared between those who had immediate breast implantation, immediate autologous reconstruction, and those who had mastectomy alone. Each breast was considered individually in analysis. Follow-up was a median of 22.2 months.
PHASE OF CARE: Late effects and survivorship
Prospective cohort study
Arm measurements were performed preoperatively and during postoperative follow-up using a perometer. Lymphedema was defined as 10% or more arm volume increase compared to preoperative. Measurement was adjusted for body weight.
Overall incidence of lymphedema was 10.58%. Among those who had immediate breast reconstruction, the incidence of lymphedema was 5.13% compared to 26.66% among those with no immediate reconstruction. Both immediate implantation (HR = 0.172, p < 0.0001) and autologous (HR = 0.467, p = 0.0077) were associated with reduced risk of lymphedema compared to no reconstruction. Factors associated with increased risk of lymphedema were a body mass index greater than or equal to 30, axillary lymph node dissection (ALND), and number of lymph nodes dissected.
Immediate implantation reconstruction does not appear to increase the risk of lymphedema compared to mastectomy alone; however, the findings are limited by significant differences in cohort characteristics shown to be associated with lymphedema incidence.
Nurses should be advised that although immediate reconstruction may not increase the risk of lymphedema, risk reduction for this population should continue.
Miller, R.C., Schwartz, D.J., Sloan, J.A., Griffin, P.C., Deming, R.L., Anders, J.C., . . . Martenson, J.A. (2011). Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. International Journal of Radiation Oncology, Biology, Physics, 79(5), 1460–1466.
To evaluate the effect of 0.1% mometasone furoate on a acute skin-related toxicity in patients undergoing breast or chest-wall radiotherapy
Patients were randomly assigned to either 0.1% mometasone furoate cream or an identical-looking placebo cream. Patients were to apply toe cream once daily to the area under treatment not less than four hours before or after radiation therapy. Creams were used throughout the radiation therapy course. No other topical agents were to be used. If the primary physician initiated a medication other than the study agent, the study medication was discontinued and evaluations continued according to the study protocol. Patients were evaluated at baseline and weekly by treatment providers.
The study took place at the May Clinic in Rochester, NY.
The study used a double-blind placebo-controlled randomized clinical trial design.
There was no significant difference between groups in the mean grade of provider-assessed radiation dermatitis. The Skindex-16 showed no statistically significant difference between groups. In the Symptom Experience Diary, patients in the mometasome arm reported less burning, itching, and redness (p < 0.02). There was no difference between groups in quality of life.
Topical mometasone furoate was associated with less burning, itching, and redness but did not show any significant effect on overall radiation-induced skin toxicity.
Findings suggest that topical corticosteroid use or mometasone does not significantly reduce the severity of radiodermatitis but may reduce patient symptoms of burning, itching, and redness. Though topical steroids may not prevent dermatitis, their use may help patients be more comfortable during radiation treatment.
Miller, C.L., Specht, M.C., Skolny, M.N., Horick, N., Jammallo, L.S., O’Toole, J., Taghian, A.G. (2014). Risk of lymphedema after mastectomy: Potential benefit of applying ACOSOG Z0011 protocol to mastectomy patients. Breast Cancer Research and Treatment, 144, 71–77.
To evaluate the rate of lymphedema occurrence in patients who recieved a mastectomy and a sentinel lymph node biopsy (SLNB) with radiation therapy (RT) compared to an axillary lymph node dissection (ALND) with or without RT, with a secondary purpose to identify risk factors for development of lymphedema
Pre/post design with repeated measures
Avoiding completion ALND and receiving SLNB with RT may decrease lymphedema risk in patients requiring a mastectomy. This study indicates that the application of the American College of Surgeons Oncology Group's Z0011 treatment protocol may reduce the risk of lymphedema for patients who receive a mastectomy.
The study provides nurses with information about SLNB with RT and how its use may decrease the risk of developing lymphedema compared to patients who recieve ALND. However, the nonrandomized, controlled trial design and the different sample sizes of each study group limit the ability to generalize this study's findings. Future randomized, controlled studies are warranted.
Miller, M., & Kearney, N. (2004). Chemotherapy-related nausea and vomiting—Past reflections, present practice and future management. European Journal of Cancer Care, 13(1), 71-81.
Support for the use of nonpharmacologic interventions for the treatment of chemotherapy-induced nausea and vomiting (CINV) was weak.
Many studies were flawed because of small sample sizes and confounding variables (e.g., stage of disease, various chemotherapy regimens, culture, patient compliance).
Preliminary available evidence suggests positive benefits through nonpharmacologic techniques; however, larger randomized trials are needed to demonstrate the exact benefits, including economic.
Miller, D.K., Chibnall, J.T., Videen, S.D., & Duckro, P.N. (2005). Supportive-affective group experience for persons with life-threatening illness: Reducing spiritual, psychological, and death-related distress in dying patients. Journal of Palliative Medicine, 8, 333–343.
The intervention was a 75-minute supportive-affective group that met monthly offering Life-Threatening Illness Supportive-Affective Group Experience (LTI-SAGE). These groups were for education and support, not group therapy. Topics included
Groups consisted of three to eight patients, with one or two group facilitators.
Two measurements were taken: baseline and 12 months
In the intervention group (n = 37), group assignment was based on diagnosis and race.
In the control group (n = 32), patients received quarterly mailings of existing, readily available self-help resource materials, with a phone call to ensure that mailings were received.
The study reported on a sample of 69 African American and Caucasian patients with any serious medical condition severe enough to create a limited life expectancy (not cause death within six months).
The study was a randomized pre/post-test trial with a longitudinal design.
Miller, S., McNutt, L., McCann, M.A., & McCorry, N. (2014). Use of corticosteroids for anorexia in palliative medicine: A systematic review. Journal of Palliative Medicine, 17, 482–485.
PHASE OF CARE: End-of-life care
APPLICATIONS: Palliative care
All studies showed an improvement in appetite with the specific steroid used in the study. Side effects were an issue for continued treatment and led to attrition of rates between 16% and 63%. Improvement in appetite was shown to continue through up to eight weeks of therapy. Side effects were a common cause of attrition.
Corticosteroids can be beneficial in treating anorexia in patients with malignancies who are in the palliative care setting. There is inadequate data to recommend a specific steroid over another or a specific dose of the steroid for the management of anorexia.
Various steroids, various routes of administration, and various doses were used, making it difficult to make any conclusions. Steroids are associated with significant side effects including gastrointestinal bleeding, oral candidiasis, and proximal myopathy.
Anorexia is a significant problem in individuals with cancer, especially in certain malignancies and at the end of life. Nurses need to be aware of potential treatment options and side effects of these treatments to enhance patients' quality of life.
Miles, C.L., Fellowes, D., Goodman, M.L., & Wilkinson, S. (2006). Laxatives for the management of constipation in palliative care patients. Cochrane Database of Systematic Reviews, 4, CD003448.
To determine the effectiveness of laxative administration for constipation in patients receiving palliative care; to differentiate among laxatives being used regarding efficacy for constipation management.
Databases searched were Medline, Embase, CANCERLIT, PubMed, CINAHL, System for Information on Grey Literature in Europe (SIGLE), National Technical Information Service (NTIS), Department of Health and Social Security (DHSS-DATA), Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Dissertation Abstracts, and the Index to Scientific and Technical Proceedings. Conference proceedings and references of articles reviewed were also hand searched.
Search keywords were palliative care, cathartics (adverse effects; therapeutic use), constipation (drug therapy), and randomized controlled trial as topic.
Studies were included in the review if they
Studies were excluded if they included healthy volunteers, patients with constipation as a result of drug misuse, patients with bowel obstruction, or other interventions such as opioid antagonists.
Two hundred twelve studies were initially retrieved. After removal of duplicates and studies that did not meet inclusion criteria, three studies were finally included. Study quality was assessed using the Jadad scale and additional criteria identified including issues of accrual, homogeneity, attrition, interventions, quality of outcome measurement, and clarity of results presentation. The review provided extensive detail on quality assessment findings and rationale for study exclusion. Included studies used senna, lactulose, danthron combined with poloxamer, misrakasneham, and magnesium hydroxide combined with liquid paraffin.
The final sample of three studies involved a total of 162 patients, with study samples ranging from 36 to 75.
The treatment of constipation in palliative care patients is not based on sufficient data from RCTs. Recommendations for laxatives may be based as much on cost as on efficacy. Polyethylene glycols are widely used in palliative care despite lack of evidence. The authors did not note evidence in this area in other patient populations that may be applicable.
This review and included studies did not provide sufficient information to draw conclusions about the laxatives in terms of weighing effectiveness versus adverse side effects.
This area could benefit from research to compare effects and cost effectiveness. Some findings suggested effect and preference for lactulose combinations, whereas lactulose tends to be much more expensive than alternatives.
Milbury, K., Chaoul, A., Biegler, K., Wangyal, T., Spelman, A., Meyers, C.A., . . . Cohen, L. (2013). Tibetan sound meditation for cognitive dysfunction: Results of a randomized controlled pilot trial. Psycho-Oncology.
Test the effect of Tibetan sound meditation on cognitive function
Patients randomly were assigned to the treatment group or a wait list control group. The intervention consisted of 12 meditation sessions that were 60 minutes long and incorporated instructions on developing breathing, awareness, and concentration skills, as well as visualization maneuvers. The intervention was offered twice a week over six weeks. A CD recording and printed materials were provided to the participants with the expectation that they practice the intervention independently at home. Objective and subjective outcome measures were evaluated at baseline and one month after completion of the intervention. Subjective measures also were completed during the last week of the intervention. Class attendance and participant satisfaction were tracked to measure the feasibility of the intervention program.
Randomized clinical trial
No significant differences were seen between the intervention or control groups in either objective or subjective measures of cognitive function over time. Although significantly less depressive symptoms were found in the treatment group (p = 0.05) during the last week of the intervention, this effect was no longer significant one month later, indicating that the result was not sustainable. No significant differences between groups over time were found for fatigue or sleep-wake disturbances. Although all treatment group participants attended at least 50% of the class sessions, compliance was a variable for both class and individual participation.
Findings from this study do not provide clear support for a significant effect of Tibetan sound meditation on cognitive function, fatigue, or sleep-wake disturbances. However, this intervention may have a limited, short-term effect on decreasing depression.
Although this treatment was not associated with improvements in objective or subjective measures of cognitive function, it was underpowered and lacking consistent patient compliance with the intervention. Further research with larger sample sizes may be warranted to determine effectiveness.
Milbury, K., Chaoul, A., Engle, R., Liao, Z., Yang, C., Carmack, C., . . . Cohen, L. (2014). Couple-based Tibetan yoga program for lung cancer patients and their caregivers. Psycho-Oncology, 24, 117–120.
To examine the feasibility and preliminary efficacy of Tibetan yoga practice as a supportive approach for patients and caregiver dyads during radiation therapy for lung cancer
Participants had two to three weekly sessions of yoga for 45–60 minutes over five to six weeks. The program included deep breathing awareness and visualization, guided meditation, compassion-based meditation, and gentle movements coordinated with specific breathing patterns. Patients and caregivers completed study measures at baseline and at the end of the program.
Single-group, prospective pilot study
Ten of 19 consenting dyads completed the study and attended a mean of 12 sessions (range = 6–15). For patients, there was a significant increase in spiritual well-being (d = 1.12, p = .03), improvement in sleep (d = .60), and depressive symptoms (d = .52). There were small effects for anxiety. For caregivers, there were significant decreases in fatigue (d = .89, p = .03) and anxiety (d = .81, p =.04) and some reduction in sleep disturbance (d = .71, p =.08). Class attendance and home practice frequency was not associated with differences seen in symptoms for either patients or caregivers.
A couple-based yoga program was seen as feasible for patients, including those with advanced disease. Medium effect sizes were seen for depressive symptoms and sleep disturbance.
Couple-based yoga sessions were shown to be feasible, and findings suggest that this type of supportive care during radiation therapy may be beneficial in some patients and caregivers for symptoms of fatigue, anxiety, depression, and sleep disturbances. The high drop-out rate suggests that many patients may not be interested or able to participate in such a program, but for those who are interested, it may be helpful. The fact, however, that the number of sessions attended and frequency of home practice were not related to the magnitude of results seen causes one to question whether it was the yoga practice or general support and attention provided that caused effects.