Herrington, J.D., Jaskiewicz, A.D., & Song, J. (2008). Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. Cancer, 112, 2080–2087.
To evaluate the efficacy of one-day versus three-day administration of aprepitant in combination with palonosetron and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC)
The study was conducted in a single site.
All patients were in active treatment.
This was a randomized, double-blind, placebo-controlled, comparative pilot study.
This study suggested that a single, 125-mg dose of aprepitant provides similar effectiveness compared to the 3-day regimen. The addition of palonosetron and dexamethasone provided protection against emesis in more than 90% of patients during the 5-day study period.
The use of aprepitant has shown to be effective in preventing acute and delayed emesis in patients who are receiving cisplatin- and anthracycline-containing therapies.
Herr, K., Titler, M., Fine, P.G., Sanders, S., Cavanaugh, J.E., Swegle, J., . . . Forcucci, C. (2012). The effect of a translating research into practice (TRIP)-cancer intervention on cancer pain management in older adults in hospice. Pain Medicine, 13, 1004–1017.
To promote the adoption of evidence-based pain practices for older adults with cancer
No significant differences existed between the E and C groups in regards to improvement in the CPPI. A decrease in pain severity was found from baseline to post-intervention in the E group, but this was not statistically significant.
Numerous factors influence a multicomponent intervention. Culture, competing priorities, intervention complexity, and other factors may have a role. Future studies should focus on more specific factors in need of change. Although the patient sample was large, only eight hospices comprised each group for the study.
Translating research into practice is a primary goal of nursing, and pain guideline translation is essential to improving pain outcomes. Translation, however, takes time and may not translate immediately to improved patient outcomes.
Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., . . . Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45–52.
Patients were randomized to receive massage therapy or standard treatment. The massage therapy group received 15 massages that were 3–30 minutes long per week by a trained massage therapist for four weeks. The control group received standard medical care alone.
Massage did show some benefit in patient mood scale assessment tools and immune system function. Specifically, reduced anxiety was found on the STAI after the first and last sessions. Reduced depression was found on the POMS depression score after the first and last sessions and from the first to the last day of the study. The SCL-90-R confirmed a reduction in depression from the first to the last day. Wilcoxon’s matched-pairs signed-ranks tests revealed an increase in dopamine and serotonin levels in the massage group; the control group showed a significant increase in norepinephrine. Natural killer cell cytotoxicity did not attain significance.
Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., . . . Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45–52.
Immediate effects: Analysis of variance on STAI revealed a significant (p < 0.001) group effect on the first day’s change scores, and subsequent Bonferroni t-tests revealed reduced anxiety scores for the massage and PMR groups when compared to the control group. The longer-term effects (SCL-90R subscale) did not differ significantly among the three groups.
Hernández Muñoz, G., & Pluchino, S. (2003). Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer. Maturitas, 44(Suppl. 1), S59–S65.
The purpose of this study was to examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flashes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. This treatment presents an off-label use of CR BNO 1055 (also known as black cohosh).
Participants took one tablet twice daily with meals for 60 days. Duration of treatment was five years for tamoxifen, and 12 months for CR BNO 1055. Participants were instructed not to initiate new therapies for hot flashes while participating in the study. Forty-six participants were randomly assigned (1-2) to receive tamoxifen 20 mg per day orally (usual-care group;mean age = 47 years); 90 participants received tamoxifen plus CR BNO 1055 corresponding to 20 mg of herbal drug (intervention group; mean age = 46 years.).
This was a two-arm, randomized and open-label trial. The primary endpoint was to assess the effect of CR BNO 1055 on the frequency and intensity of hot flushes.
Control visits occurred every two months, when the supply of CR BNO 1055 was replaced and clinical assessments made. Hot flashes were considered severe when five or more heat episodes occurred during the day and were accompanied by sweating, sleep disturbances, feeling of irritation, and anxiety. A few episodes of heat with discrete sweating were classified as moderate hot flushes. Participants completed hot flash diaries at baseline, at every control visit, and at the end of the study at 12 months.
The hot flash patterns were significantly different between the two groups using Fisher’s exact test (p < 0.01). Among the 46 study participants included into the usual-care group, 73.9% experienced severe hot flushes and 26.1% moderate symptoms. Among the 90 study participants in the intervention group, at the end of the study, 46.7% were free of hot flashes, and 24.4% reported severe symptoms.
In the intervention group, the administration of CR BNO 1055 in combination with tamoxifen for a 12-month period significantly reduced the vasomotor episodes induced by tamoxifen in breast cancer survivors.
Methodologic problems included an open label trial and unbalanced arms (twice as many participants in the Black Cohosh group as in the usual care group).
Hernandez-Reif, M., Ironson, G., Field, T., Hurley, J., Katz, G., Diego, M., . . . Burman, I. (2004). Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57, 45–52.
The intervention consisted of 30-minute progressive muscle relaxation (PMR) sessions three times per week for five weeks versus massage therapy for five weeks versus a control group. Participants completed the State-Trait Anxiety Inventory (STAI) before and after the first and last sessions. Longer-term anxiety effect was examined by comparing pre first day and pre last day measures on the STAI and by the Symptom Checklist (SCL)-90R (revised) anxiety subscale administered on the first and last days of intervention. Blood samples were drawn to evaluate immune response for natural killer (NK) cell production, cytotoxicity, and hormone levels.
The study reported on three groups: PMR (n = 20), massage therapy (n = 22), and control (n = 16).
A three-group experimental study design was used.
ANOVA on STAI revealed a significant (p < 0.001) group effect on the first day’s change scores; subsequent Bonferroni t tests revealed reduced anxiety scores for the massage and PMR groups when compared to the control group. The longer-term effects (SCL-90R subscale) did not differ significantly among the three groups. Massage therapy demonstrated an increase in dopamine, serotonin, NK cells, and lymphocytes.
This study supports the use of massage treatment and relaxation therapy to reduce anxiety, pain, and depression in women with breast cancer.
Hernandez-Reif, M., Field, T., Ironson, G., Beutler, J., Vera, Y., Hurley, J., . . . Fraser, M. (2005). Natural killer cells and lymphocytes increase in women with breast cancer following massage therapy. International Journal of Neuroscience, 115, 495–510.
The intervention was five weeks of massage therapy sessions for 30 minutes per session. Massages were given three times per week, for a total of 15 massages (control group).
A longitudinal randomized controlled trial design was used.
Anxiety was reduced in the massage group on STAI (p < 0.05) after the first and last sessions (decreased by 25%).
Herbst, C., Naumann, F., Kruse, E.B., Monsef, I., Bohlius, J., Schulz, H., & Engert, A. (2009). Prophylactic antibiotics or G-CSF for the prevention of infections and improvement of survival in cancer patients undergoing chemotherapy. Cochrane Database of Systematic Reviews, 1, CD007107.
The purpose of the study was to compare the effectiveness of prophylactic G-CSF or GM-CSF with prophylactic antibiotics for the prevention of febrile neutropenia, severe infection, infection-related mortality, and overall mortality in patients of all ages with any type of malignancy receiving myeloablative chemotherapy.
The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE databases were searched from January 1985 to January 2008, as were proceedings from the American Society of Clinical Oncology and the American Society of Hematology (2000–2007). In addition, references from identified trials, relevant reviews, guidelines, and ongoing clinical trials were searched.
Key words included granulocyte–colony-stimulate factors (G-CSF), granulocyte macrophage–colony-stimulating factors(GM-CSF), antibiotics, cancer
Studies were included if they were randomized, controlled trials conducted from January 1980 to January 2008 comparing G-CSF or GM-CSF prophylaxis with antibiotic prophylaxis in patients with cancer receiving myeloablative chemotherapy.
Studies were excluded if they were non-randomixed and were quasi-randomized with information on perioperative infection prophylaxis, stem cell mobilization, and priming of malignant cells with G-CSF or GM-CSF.
10,924 abstracts and 473 full-text articles were reviewed.
Forty-four were considered for the review.
Two articles were included in the final review.
Subgroup analyses conducted for types of underlying malignancies, baseline risk factors for febrile neutropenia for infection, inpatient versus outpatient setting, type of treatment (chemotherapy, hematopoietic stem cell transplantation), types of growth factors administered, age, and antimycotic prophylactic administration.
It was not possible to conduct a meta-analysis as planned due to differences in outcomes among the two studies included in this review.
Studies that were excluded were made up of 36 trials that compared antibiotics and G-CSF prophylaxis to antibiotic prophylaxis alone, four trials that compared prophylactic antibiotics and growth factors to growth factors prophylaxis alone, one due to different chemotherapeutic agents used in each of the study arms, and one non-randomized study comparison. Therefore, only two studies fit the exact inclusion criteria.
In the two trials evaluated, both showed efficacy for use of prophylactic colony-stimulating factors (G-CSF or GM-CSF) or antibiotics for decreased risk of infection; however neither colony-stimulating factors or antibiotics proved better than the other in adults with solid tumors who received myeloablative chemotherapy. No differences were found for infection-related mortality, treatment-related or early mortality, febrile neutropenia, the incidence of severe infections, or infectious episodes.
The use of prophylactic treatment with G-CSF, GM-CSF, or antibiotics for the reduction of risk of infections among adults receiving myeloablative chemotherapy for the treatment of small cell lung cancer or breast cancer is effective; however, use of a colony-stimulating factor versus an antibiotic is inconclusive in terms of better efficacy. More trials are warranted to evaluate prophylactic antibiotic versus colony-stimulating factor use for reduced risk of neutropenia, febrile neutropenia, infections, hospitalizations, and survival.
Implications for nursing practice include knowledge of the known literature and lack of information available. Use of a prophylactic treatment (colony-stimulating factor or antibiotic) for infection prevention is warranted.
Heras, P., Hatzopoulos, A., Heras, V., Kritikos, N., Karagiannis, S., & Kritikos, K. (2011). A comparative study of intravenous ibandronate and pamidronate in patients with bone metastases from breast or lung cancer: Effect on metastatic bone pain. American Journal of Therapeutics, 18(5), 340–342.
To compare the effects of ibandronate with those of pamidronate in patients with bone metastases from breast or lung cancer
All patients were diagnosed with either breast or lung cancer and had scan-confirmed bone metastases. Patients were in one of two treatment groups, each receiving IV medication every four weeks for six months. Group A received 6 mg ibandronate. Group B received 90 mg pamidronate.
The authors are practitioners at three facilities in Greece: General Hospital of Nafplio, General Hospital of Kos, and the Hellenic Medical Society for the Study of Psychosomatic Problems, Athens. The report does not specify that these were locations used in the study, however.
Comparative study
Patient demographics were similar in both groups. At baseline, linear analog scale scores were similar in both groups. Compared to the pamidronate group, the ibandronate group had lower pain scores, higher mobility and QoL scores, and lower serum calcium levels. Patients who were taking ibandronate needed fewer analgesics (p = 0.001). In regard to bone pain, patients taking ibandronate reported scores in the range 0–1 and patients taking pamidronate reported scores in the range 3–4.
Ibandronate may be superior to pamidronate in alleviating pain, improving mobility and QoL, and reducing bone resorption in patients with bone metastases from breast or lung cancer.
Evidence from this study strongly supported the effectiveness of bone-modifying agents in reducing the pain of patients with bone metastases. This study attempted to compare the effectiveness of different bisphosphonates. The size and limitations of the trial did not permit researchers to draw firm conclusions regarding the usefulness of one agent over another. Further research is needed to determine the relative efficacy of bone-modifying agents in pain control.
Hensley, M.L., Hagerty, K.L., Kewalramani, T., Green, D.M., Meropol, N.J., Wasserman, T.H., . . . Schuchter, L.M. (2009). American Society of Clinical Oncology 2008 clinical practice guideline update: Use of chemotherapy and radiation therapy protectants. Journal of Clinical Oncology, 27(1), 127–145.
STUDY PURPOSE: To update the American Society of Clinical Oncology (ASCO) guidelines on the use of chemotherapy and radiation therapy protectants for patients with cancer
PHASE OF CARE: Active antitumor treatment
Using various chemotherapy/radiotherapy protectants is useful in certain malignancies for prevention of toxicity related to therapy. Future trials need to be blinded with placebo-controlled arms to provide key evidence to ensure safe guideline recommendations.
Most of the trials lacked a placebo arm in the studies with the quality of the literature reviewed being limited. The panel found that different instruments and/or assessment tools varied for assessing the same outcome in multiple trials.
Nurses caring for this patient population need to be aware and understand that there are medications that can be given to prevent certain chemotherapy/radiation toxicities.