Koopmans, G., Simpson, K., De Andres, J., Lux, E. A., Wagemans, M., & Van Megen, Y. (2014). Fixed ratio (2:1) prolonged-release oxycodone/naloxone combination improves bowel function in patients with moderate-to-severe pain and opioid-induced constipation refractory to at least two classes of laxatives. Current Medical Research and Opinion, 30, 2389–2396.
To determine the effect of a combination of oxycodone and naloxone prolonged release tablets (OXN PR) on opioid-induced constipation and pain in patients with moderate to severe cancer- or noncancer-related pain
Patients had received OXN PR in prior double-blinded, multicenter, randomized studies. In one previous study (also a pooled analysis of two Phase III studies), patients with noncancer-related pain received 12 weeks of OXN PR or oxycodone prolonged release (Oxy PR) at the dose equivalent of 20–50 mg per day or 60–120 mg per day. After a 7–28-day period, patients were titrated to an effective analgesic dose of Oxy PR. In a previous Phase II study, patients with moderate to severe cancer-related pain were screened for 3–10 days and then switched to OXN PR or Oxy PR for four weeks (20–120 mg per day). In all prior studies, bisacodyl at 10 mg per day could be taken orally as a rescue laxative 72 hours after a previous bowel movement or when the patient experienced discomfort for a maximum of five doses in seven consecutive days. In all previous studies, data were collected at screening, at the start of the intervention period, and at the end of the intervention period. Laxative use was documented throughout the intervention period in all studies.
Pooled analysis
The high BFI score at the time of screening indicated that both groups of patients experienced constipation and that patients with cancer-related pain experienced more symptoms. OXN PR clinically and statistically improved constipation in patients with chronic cancer- and noncancer-related pain. Laxative use decreased during the intervention period, and more patients fell within the range of normal bowel habits as the intervention progressed. Pain scores did not change during the intervention period although there was a nonsignificant trend of pain improvement in patients with cancer-related pain.
OXN PR may be a viable pharmacologic intervention to achieve pain control in patients with cancer-related pain while minimizing the symptoms of opioid-induced constipation. OXN PR reduced laxative use and increased the number of patients who reported normal bowel function. OXN PR did not change pain scores.
Kono, T., Hata, T., Morita, S., Munemoto, Y., Matsui, T., Kojima, H., . . . Mishima, H. (2013). Goshajinkigan oxaliplatin neurotoxicity evaluation (GONE): A phase 2, multicenter, randomized, double-blind, placebo-controlled trial of goshajinkigan to prevent oxaliplatin-induced neuropathy. Cancer Chemotherapy and Pharmacology, 72, 1283–1290.
To evaluate the efficacy of a Japanese medicine called goshajinkigan (TJ-107) for preventing oxaliplatin-induced neuropathy, compared to placebo controls, and also to evaluate its safety
Patients were randomized to receive goshajinkigan ( TJ-107) 7.5 mg per day day, a mix of extracts of 10 crude herbs, or placebo for 26 weeks starting on the first day of chemotherapy. Neuropathy was measured before each chemotherapy cycle every two weeks until the eighth chemotherapy cycle and every four weeks thereafter until 26 weeks. Patients randomly were assigned to the intervention or control group.
Although there was a trend toward lower neuropathy scores as measured by the FACT/GOG-NTX in the intervention group at eight weeks (p = .421) and 26 weeks (p = .151), the differences were not statistically significant. The incidence of grade 2 peripheral neuropathy or greater until the eighth cycle was 39% in the experimental group and 51% in the control group (RR = 0.76, 95% CI 0.47–1.21), and the incidence of grade 3 or greater neurotoxicity was 7% in the treatment group and 13% in the placebo group (RR = 0.51, 95% CI 0.14–1.92). The time to development of grade 2 or greater toxicity was 5.5 months in the experimental group and 3.9 months in the placebo group (RR = 0.65, 95% CI 0.36–1.17). No differences were observed between those getting the different FOLFOX regimens. The goshajinkigan was tolerated well. Adverse effects were similar between study groups and most likely caused by the chemotherapy, but vomiting was significantly less prevalent in the treatment group (p = .029).
Goshajinkigan may delay development of grade 2 or greater oxaliplatin-induced peripheral neuropathy, and there was a trend toward less severe chemotherapy-induced peripheral neuropathy in the intervention group at 8 and 26 weeks as compared to the control group.
This study showed that administration of goshajinkigan, a traditional Japanese kampo medicine, was associated with reduced prevalence and severity of neurotoxicity among patients receiving oxaliplatin and was tolerated well by patients. Further study is needed to support the use of goshajinkigan for oxaliplatin-induced peripheral neuropathy. Goshajinkigan may not be widely available in the United States or outside of Japan.
Kono, T., Satomi, M., Chisato, N., Ebisawa, Y., Suno, M., Asama, T., . . . Furukawa, H. (2010). Topical application of hangeshashinto (TJ-14) in the treatment of chemotherapy-induced oral mucositis. World Journal of Oncology, 1, 232–235.
To determine if hangeshashinto (TJ-14) is an effective treatment for oral mucositis
Patients with oral lesions 7–10 days after chemotherapy were given a 50 ml oral rinse with 2.5 g of TJ-14 and tap water three times per day for 7 days. Patients held the solution in their mouth for 10 seconds and spit it out. TJ-14 also was applied to the lesions with a cotton pellet as soon as the lesion appeared. Patients could not eat or drink 30 minutes before or after treatment. No other mucosal treatments were used during the study. Two blinded physicians graded mucositis.
In this study, 92.8% of patients had improvements in oral mucositis. There was a significant reduction in CTCAE grades of mucositis for all participants from 2.4 ± 0.8 to 1.1 ± 0.8 (p = 0.0012). No adverse events or side effects from NJ-14 were reported.
NJ-14 was effective at improving oral mucositis and did not have any reported side effects in this small sample. However, caution must be used in interpreting this data due to the limitations of the study.
NJ-14 is a promising intervention to treat chemotherapy-induced oral mucositis; however, more research is needed from large RCTs.
Kong, M., Shin, S.H., Lee, E., & Yun, E.K. (2014). The effect of laughter therapy on radiation dermatitis in patients with breast cancer: A single-blind prospective pilot study. OncoTargets and Therapy, 7, 2053–2059.
To measure the effectiveness of laughter therapy for preventing radiation-induced dermatitis in patients with breast cancer who are receiving radiation therapy (RT)
Thirty-seven patients were enrolled in the study. Eighteen patients were assigned to the experimental group, which received laughter therapy during radiation treatment, based on their preference to participate. Nineteen patients who did not want to participate in the laughter therapy were assigned to the control group. The laughter therapy started at the beginning of therapy and continued until completion of RT. In this three-part intervention study, patients were assessed by staff observation or a questionnaire before and after laughter therapy. Patients in the control group were not allowed to use any prophylactic creams or lotion (p. 2054).
PHASE OF CARE: Active antitumor treatment
Single-blind, two-group, prospective, nonrandom design
The authors stated that, although laughter therapy showed favorable therapeutic efficacy in preventing dermatitis and alleviating pain, they could not draw a definite conclusion because of the lack of statistical significance. An additional study of a larger sample group is necessary. Some limitations exist in this small pilot study, which makes it difficult to interpret the data and draw conclusions.
This single-blind, prospective, pilot study showed that laughter therapy can be beneficial in preventing radiation-induced dermatitis in patient with breast cancer; however, a well-designed randomized study with a larger sample size is needed to confirm the efficacy of the study.
Laughter therapy may have a beneficial effect on patients with radiation dermatitis undergoing breast cancer treatment. However, not enough data exist to support the sole use of this intervention during treatment.
Kongsgaard, U.E., Eeg, M., & Greisen, H. (2014). The use of Instanyl® in the treatment of breakthrough pain in cancer patients: A 3-month observational, prospective, cohort study. Supportive Care in Cancer, 22, 1655–1662.
To evaluate Instanyl® for breakthrough pain in patients with cancer in real-life settings
This study followed adult patients with cancer receiving Instanyl® in seven countries at 61 centers. The Brief Pain Inventory Short Form (BPI) and patient Treatment Satisfaction Scale (TSS) questionnaires were used to assess patient satisfaction with pain management. Descriptive statistics of the patient population were also collected. The Instanyl® doses received by patients were 50, 100, and 200 micrograms, and data were collected at three time points: baseline, week 4, and week 13.
Observational prospective cohort study
The primary outcome variables were success of titration, measured by whether maintenance dose level was achieved, and the dose level of Instanyl® (maintenance dose). The secondary outcome variables measured were changes in maintenance dose and the level of background pain medication, severity and impact of pain on daily life (assessed by the BPI), and satisfaction with current pain medicine (assessed by the TSS). The BPI and TSS were only used in the United Kingdom and in France and were assessed at baseline and during week 4. Adverse drug reactions were measured as well as reasons for and time to Instanyl® termination.
The successful titration of Instanyl® to a maintenance dose was achieved in 84.5% of patients. There was a difference noted between different countries with successful titration rates highest in Greece and Norway and lowest in France and the United Kingdom. The majority of the patients who were successfully titrated achieved this with 50 micrograms of fentanyl, which was the lowest dose. Most patients showed no change in the maintenance dose strength throughout the study even though disease progression was expected. 49.8% of patients were successfully titrated at 50 micrograms, the lowest dose. Treatment was followed to the duration of 13 weeks. In 4.5% of patients, termination was due to lack of efficacy; in 2.3% it was due to adverse effects; and in 7.1% it was due to the inability to successfully titrate the medication. Patients' worst-pain scores, pain severity, and pain interference with activities declined significantly within the first four weeks (p < .001).
The rate of successful titration and pain management using Instanyl® was high in this study, and successful titration was often achieved with the lowest possible dose of Instanyl®. Patients were more satisfied with their pain management and had reductions in pain severity, worst-pain score, and pain interference with daily activities.
This study adds to the body of evidence regarding the efficacy of opioid nasal spray for breakthrough pain. The authors suggest that patients who did not respond were likely those for whom titration to full dosage was not achieved. Nurses need to be aware of full dosage needs for efficacy. There continues to be a lack of evidence regarding the long-term effects and any potential adverse effects on the nasal cavity for this medication type.
Kong, M., & Hong, S.E. (2013). Topical use of recombinant human epidermal growth factor (EGF)-based cream to prevent radiation dermatitis in breast cancer patients: A single-blind randomized preliminary study. Asian Pacific Journal of Cancer Prevention, 14, 4859–4864.
To determine if the use of a human epidermal growth factor (EGF)-based cream can prevent radiation dermatitis in patients with breast cancer treated with radiation
Patients with breast cancer needing post-operative radiation randomly were assigned to use human recombinant EGF-based cream (intervention) or general supportive skin care (control). The intervention group applied study cream three times daily to the radiated area from start of treatment through two weeks post-completion of treatment. The control group washed gently with or without mild soap, patting to dry. No cosmetics, perfumes, creams, or lotions were allowed on the treated area in the control arm.
Examination of site was completed prior to RT, weekly during RT, and six weeks post-RT. Skin changes were scored using the Radiation Therapy Oncology Group (RTOG) criteria by a radiation oncologist blinded to group assignment. Pain was evaluated with a 10-point visual analog scale. Intervention patients completed a questionnaire regarding ease of cream application at the end of the study.
Although there was a difference in the intervention and control groups in terms of grade 3 dermatitis, (15% compared to 40%), there was no statistical difference between the intervention of human recombinant EGF-based cream and the control of supportive skin care. As with previous studies, total RT dose and lymph node radiation were prognostic factors for grade 3 radiation dermatitis. This study did not look at patient-related prognostic factors that potentially contribute to increased radiation dermatitis.
There continues to be no “best practice” for prevention and treatment of radiation dermatitis. Practice varies worldwide. Further studies with a large sample size and inclusion of a double-blinding would be useful for this product as several studies have shown with EGF for wound healing.
Komatsu, Y., Okita, K., Yuki, S., Furuhata, T., Fukushima, H., Masuko, H., . . . Takahashi, Y. (2015). Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with palonosetron. Cancer Science, 106, 891–895.
To evaluate chemotherapy-induced nausea and vomiting and adverse events when dexamethasone is eliminated on days 2 and 3 of moderately emetogenic chemotherapy (not including anthracyclines or cyclophosphamide) in combination with palonosetron or another 5HT3 receptor antagonist
The control group received 9.9 mg of dexamethasone IV then 0.75 mg of palonosetron IV before moderately emetogenic chemotherapy then either 8 mg of oral dexamethasone or 6.6 mg of IV dexamethasone on days 2 and 3 of chemotherapy. The treatment group received only 9.9 mg of dexamethasone IV then 0.75 mg of palonosetron IV before moderately emetogenic chemotherapy and no additional prophylactic antiemetics. Rescue antiemetic drugs (excluding dexamethasone, NK1 receptor antagonists, serotonin reuptake inhibitors, and serotonin–norepinephrine reuptake inhibitors) were allowed for both the treatment and control groups.
Open-label, noninferiority, randomized, comparative, phase 3 study
The noninferiority of the experimental group in regard to complete response rate (acute and delayed phases) and complete control rate (overall, acute, and delayed phases) was demonstrated. There was no difference between the treatment and control groups. A subgroup analysis according to age, sex, and chemotherapy showed no statistical differences in complete response rates. No significant difference in adverse events was found between the treatment and control group with primary events in both groups being constipation, hiccups, anorexia, and elevated alanine transaminase.
There was no difference in chemotherapy-induced nausea and vomiting (acute and delayed) or adverse events between one-day dexamethasone plus palonosetron versus three-day dexamethasone plus palonosetron among patients receiving moderately emetogenic chemotherapy (not including anthracyclines or cyclophosphamide).
The one-day administration of dexamethasone (with palonosetron) was adequate in controlling acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy when the chemotherapy did not include anthracyclines or cyclophosphamide.
Komatsu, H., Hayashi, N., Suzuki, K., Yagasaki, K., Iioka, Y., Neumann, J., . . . & Ueno, N.T. (2012). Guided self-help for prevention of depression and anxiety in women with breast cancer. ISRN Nursing, 716367.
Evaluate the effects of a self-help program on depression and anxiety in women with breast cancer receiving chemotherapy
Patients were assigned to intervention or treatment groups by authors (not random assignment). The intervention was a self-learning package aimed at rehearsing the chemotherapy procedure, improving beliefs in managing side effects, and helping build problem-solving skills. This group also was given a professional-led support group that met two to three times during the study. The control group received usual care including a chemotherapy education leaflet. Nurses monitored patient progress from review of patient diaries in the intervention group that documented side effects and self management performed at the beginning of each cycle of chemotherapy. Nurses involved with the intervention were educated and demonstrated increased knowledge regarding improving coping processes in daily living. Data were collected at baseline, one week, three months, and six months.
PHASE OF CARE: Active antitumor treatment
Non-random, two-group comparison, quasi-experimental—historical control approach
No significant differences were found in outcomes between study groups. Study measures improved over time in all patients.
This study did not find that the intervention tested here had an effect on depression or anxiety.
This particular study did not demonstrate effectiveness of the intervention tested here. The study had several limitations. Anxiety and depression improved in all patients, suggesting that usual nursing education provided was just as effective as the expanded approach used here. Several study results have suggested that interventions aimed at improving anxiety and depression are most effective for patients who have clinically relevant anxiety and depression.
Kollmannsberger, C., Schittenhelm, M., Honecker, F., Tillner, J., Weber, D., Oechsle, K., . . . Bokemeyer, C. (2006). A phase I study of the humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody EMD 72000 (matuzumab) in combination with paclitaxel in patients with EGFR-positive advanced non-small-cell lung cancer (NSCLC). Annals of Oncology, 17, 1007–1013.
To evaluate the effectiveness of dexamethasone and pyridoxine on the frequency and severity of palmar-plantar erythrodysesthesia (PPE) in patients with solid tumors receiving pegylated liposomal doxorubicin (PLD).
Evaluable patients had at least two cycles of therapy. A total of 51 cycles of PLD was applied to the 19 patients. The maximum tolerated dose was 60 mg/m2 every 28 days. In a second step, interval reductions at the highest four weekly doses from 28 to 21 to 14 days were planned. Patients received oral dexamethasone 8 mg BID on days 1 to 5 with vitamin B6 100 mg BID continuously along with PLD.
PPE was evaluated with a scale from grade 1 to 4. The specific grading scale was not discussed.
Compared to reported frequencies of up to 25%, the incidence of PPE caused by PLD appeared to decrease with concomitant dexamethasone and vitamin B6.
Koller, A., Miaskowski, C., De Geest, S., Opitz, O., & Spichiger, E. (2012). A systematic evaluation of content, structure, and efficacy of interventions to improve patients' self-management of cancer pain. Journal of Pain and Symptom Management, 44, 264–284.
Although the efficacy of various intervention components could not be clearly delineated, this systematic review provides an overview of the various structural and content components of intervention studies to improve cancer pain management and an evaluation of combinations of components.
Nurses need to be aware of the various structural and content components of interventions to support patients’ self-management of cancer pain. The interventions should be culturally appropriate and include written material; a face-to-face educational session of at least 15 minutes; and information about pain treatment, cognitive barriers to pain management, and implementation of self-management pain strategies.