Kutner, J.S., Smith, M.C., Corbin, L., Hemphill, L., Benton, K., Mellis, B.K., . . . Fairclough, D.L. (2008). Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer: A randomized trial. Annals of Internal Medicine, 149, 369–379.
To test the hypothesis that massage would decrease pain and analgesic medicine use
To explore effects on quality of life and physical and emotional symptom distress
Patients were randomly assigned to a massage treatment group or to a control group in which patients received simple touch controlled for time and attention. Individual baseline data for disease characteristics, pain, symptom distress, quality of life, functional status, expectations from massage, and concurrent interventions were collected within 72 hours of study inclusion and at three weekly visits over the three to four weeks of study participation, for measurement of sustained effects. Data collectors were blinded to study group assignment. Participants received up to three 30-minute treatments over two weeks with at least 24 hours between treatment sessions, according to a schedule jointly determined by the patient and the treatment provider. Treatment providers obtained immediate outcome data prior to and following each treatment. All participants received routine care in addition to study interventions. Massage intervention included gentle effleurage, petrissage, and myofascial trigger point release. The most frequently massaged areas were neck and upper back and arms, hands, lower legs, and feet. Massages were performed by licensed massage therapists who had at least six months’ experience working with patients with advanced cancer. Control touch included placement of both hands on the participant bilaterally on the neck, shoulder blades, lower back, calves, heels, clavicles, lower arms, hands, patellae, and feet with light and consistent pressure. All treatment providers had standardized hands-on training and were evaluated for competency.
The study was a randomized, single-blind, controlled trial.
Both massage and touch were associated with significant improvements in immediate and sustained pain outcomes. Massage was superior to touch, but the difference was not statistically significant. Both groups demonstrated statistical, but not clinically significant, improvement in BPI scores. Both massage and simple touch were reported to be associated with statistically significant immediate improvement in mood, with massage showing statistically superior effect compared to touch. Confidence intervals were provided, but significance levels were not reported. Both groups demonstrated improvement in physical and emotional symptom distress and quality of life across weekly evaluations, but there were no differences between groups. There were no adverse effects associated with the interventions, and no differences in general adverse events or mortality between groups. Differences in pain medication use were not reported.
Both massage and simple touch appeared to have immediate beneficial effects on pain and mood in these patients. Both groups experienced slight improvement in pain, quality of life, and symptom distress over time. These changes were minimal, showing statistical significance but not clinical relevance.
Simple touch appeared to have a short-term positive effect on patient mood and pain experience. This is an intervention that should be easy to provide for patients and could be something that caregivers could also be educated to provide. This intervention could be useful for intermittent use as an adjunct to other interventions for pain management. Formal massage did not provide significantly greater effects. Given findings of simple touch in the population studied here, evaluation of this approach in other patient groups can be useful.
Kutner, J.S., Smith, M.C., Corbin, L. Hemphill, L., Benton, K., Mellis, B.K., . . . Fairclough, D.L. (2008). Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer: A randomized trial. Annals of Internal Medicine, 149, 369–379.
To test the hypothesis that massage would decrease pain and analgesic medicine use
Patients were randomly assigned to a massage treatment group or to a control group in which patients received simple touch controlled for time and attention. Individual baseline data for disease characteristics, pain, symptom distress, quality of life, functional status, expectations from massage, and concurrent interventions were collected within 72 hours of study inclusion and at three weekly visits over the three to four weeks of study participation for measurement of sustained effects. Data collectors were blinded to study group assignment. Participants received up to three 30-minute treatments over two weeks, with at least 24 hours between treatment sessions, according to a schedule jointly determined by the patient and the treatment provider. Treatment providers obtained immediate outcome data prior to and following each treatment. All participants received routine care in addition to study interventions. Massage intervention included gentle effleurage, petrissage, and myofascial trigger point release. Most frequently massaged areas were neck and upper back, arms, hands, lower legs, and feet. Massages were performed by licensed massage therapists who had at least six months’ experience working with patients with advanced cancer. Control touch included placement of both hands on the participant bilaterally on the neck, shoulder blades, lower back, calves, heels, clavicles, lower arms, hands, patellae, and feet with light and consistent pressure. All treatment providers had standardized hands-on training and were evaluated for competency.
A randomized, single-blind, controlled trial design was used.
Both massage and touch were associated with significant improvements in immediate and sustained pain outcomes. Massage was superior to touch, but the difference was not statistically significant. Both groups demonstrated statistical, but not clinically significant, improvement in BPI scores. Both massage and simple touch were reported to be associated with statistically significant immediate improvement in mood, with massage showing statistically superior effect compared to touch. Confidence intervals were provided but significance levels were not reported. Both groups demonstrated improvement in physical and emotional symptom distress and quality of life across weekly evaluations, but there were no differences between groups. There were no adverse effects associated with the interventions, and no differences in general adverse events or mortality between groups. Differences in pain medication use were not reported.
Both massage and simple touch appeared to have immediate beneficial effects on pain and mood in these patients. Both groups experienced slight improvement in pain, quality of life, and symptom distress over time. These changes were minimal, showing statistical significance but not clinical relevance.
Simple touch appeared to have a short-term positive effect on patient mood and pain experience. This is an intervention that should be easy to provide for patients, and could be something that caregivers could also be educated to provide. This intervention could be useful for intermittent use as an adjunct to other interventions for pain management. Formal massage did not provide significantly greater effects. Given findings of simple touch in the population studied here, evaluation of this approach in other patient groups can be useful.
Kus, T., Aktas, G., Alpak, G., Kalender, M.E., Sevinc, A., Kul, S., . . . Camci, C. (2016). Efficacy of venlafaxine for the relief of taxane and oxaliplatin-induced acute neurotoxicity: A single-center retrospective case-control study. Supportive Care in Cancer, 24, 2085–2091.
To evaluate the effect of venlafaxine 75 mg daily oral administration on peripheral neuropathy (PN) pain severity reduction rates in patients on taxane- or oxaliplatin-based chemotherapy with moderate to severe painful chemotherapy-induced PN (CIPN) compared to participants who refused treatment
Retrospective, case-control, nonblinded design with a venlafaxine-treated group and a case-matched control group that had rejected CIPN treatment
Every three weeks, PN was measured using the 10-item NPSI mean composite score, which ranged from 0 (“no pain”) to 10 (“worst pain imaginable”). Each NPSI item used the same 0–10 NRS to measure patient-reported severity for the past 24 hours of various neuropathic pain symptoms (e.g., burning pain, pain provoked by cold, abnormal pin-and-needle sensations). The severity of venlafaxine-associated adverse effects was also measured using the CTCAE, version 4.03, ranging from 0 (normal) to 4 (life-threatening).
This study provided weak evidence supporting the superiority of venlafaxine compared to no venlafaxine in decreasing PN symptoms among participants with moderate to severe painful CIPN and mild depression while receiving taxane- and/or platinum-based chemotherapy. Participants who received venlafaxine 75 mg once daily experienced a reduction in painful and nonpainful PN symptoms after three weeks that continued through nine weeks, compared to no change in participants who did not receive venlafaxine. Participants with milder PN before treatment experienced the most benefit. However, these results may not be reliable or valid because of the retrospective design and potentially biased study procedures/methods/analysis.
Additional testing of venlafaxine in large prospective, randomized, controlled trials is needed before it can be used in clinical practice to treat CIPN. However, the positive results of this trial emphasize the importance of continual nursing assessment of PN signs and symptoms throughout chemotherapy because pain treatments may be most beneficial to patients with acute mild CIPN.
Kusuki, S., Hashii, Y., Yoshida, H., Takizawa, S., Sato, E., Tokimasa, S., . . . Ozono, K. (2009). Antifungal prophylaxis with micafungin in patients treated for childhood cancer. Pediatric Blood and Cancer, 53, 605–609.
The primary aim of this study was to determine if micafungin is an effective and safe antifungal prophylaxis to be used for neutropenic pediatric patients undergoing chemotherapy treatment or stem cell transplantation treatment for cancer.
Patient records were reviewed for pediatric oncology patients who received micafungin via IV (3 mg/kg per day) while they were neutropenic from May 2006 to September 2008. A total of 40 children were included in a record review that encompassed 146 patient cycles of chemotherapy.
A single-site setting.
Retrospective
Development of probable, proven, or suspected invasive fungal infection.
Of the 40 records reviewed, a total of 131 patient cycles were noted for chemotherapy and 15 patient cycles for those undergoing stem cell transplantation. Thirty of 40 patients had successful prevention of invasive fungal infection. Only one patient developed a diagnosed fungal infection, the rest of the failures were suspected fungal infections.
Based on this study, it appears that micafungin may be a safe and effective prophylactic treatment for fungal infection in pediatric patients with cancer. A larger randomized study would be beneficial to prove the success rates in a larger randomized group.
Micafungin is generally tolerated well with minor side effects and minimal drug-to-drug interactions as opposed to other treatment for fungal prophylaxis. More exclusive, randomized studies are needed to determine if it is appropriate for all patient populations and demographics.
Kusagaya, H., Inui, N., Karayama, M., Fujisawa, T., Enomoto, N., Kuroishi, S., . . . Suda, T. (2015). Evaluation of palonosetron and dexamethasone with or without aprepitant to prevent carboplatin-induced nausea and vomiting in patients with advanced non-small-cell lung cancer. Lung Cancer, 90, 410–416.
To compare the efficacy of triplet versus doublet antiemetic prophylaxis in patients receiving carboplatin-based chemotherapy
Patients were randomized to triple drug or doublet prophylaxis. Both groups received palonosetron 0.75 mg on day 1 and dexamethasone 8 mg on days 1–3. In addition, those randomized to triple drug therapy received aprepitant 125 mg on day 1 and 80 mg on days 2–3. Physicians recorded the use of rescue therapy.
PHASE OF CARE: Active antitumor treatment
Open-label, randomized, two-group trial
Complete response rate was defined as no vomiting or rescue therapy.
Aprepitant and control groups showed overall complete response rates of 80.5% and 76.9%, respectively. No significant difference existed between groups. No differences existed in patient reports of nausea.
Doublet antiemetic prophylaxis using palonosetron was as effective as triplet antiemetic treatment for the control of chemotherapy-induced nausea and vomiting (CINV).
The finding suggest that antiemetics with a 5-HT3 and dexamethasone were as effective as triplet therapy, including an NK1, for control of CINV in patients receiving carboplatin. The 5-HT3 used here was palonosetron. A variety of mixed evidence exists regarding the comparative efficacy of doublet versus triplet antiemetics for CINV, as well as the comparative efficacy of dexamethasone-paring regimens and olanzapine-based regimens. Ongoing research and evaluation of comparative effectiveness for various chemotherapy regimens are needed. Multiple factors need to be considered in individualization of antiemetic treatments, and nurses need to evaluate the effectiveness of interventions across cycles to provide the most effective regimen for each patient.
Kurzrock, R., Cortes, J., Thomas, D.A., Jeha, S., Pilat, S., & Talpaz, M. (2001). Pilot study of low-dose interleukin-11 in patients with bone marrow failure. Journal of Clinical Oncology, 19, 4165–4172.
Six of 16 patients (38%) showed an increase in platelet count greater than 70K, mostly within the first two-week course. Of the six responders, their baseline platelet count was 1–48; none received transfusions. One patient also received granulocyte colony-stimulating factor and erythropoietin; time to response was approximately 20 weeks. Two patients had an abrupt decrease in platelet counts in the two-week rest period between courses. Response duration was 12–30 weeks. Side effects were mild peripheral edema (two patients treated with furosemide 20 mg PO), conjunctival infection, and myalgia; seven patients had no side effects.
Kurosaka, S., Satoh, T., Chow, E., Asano, Y., Tabata, K., Kimura, M., . . . Baba, S. (2012). EORTC QLQ-BM22 and QLQ-C30 quality of life scores in patients with painful bone metastases of prostate cancer treated with strontium-89 radionuclide therapy. Annals of Nuclear Medicine, 26, 485–491.
To evaluate the effect of Sr-89 radionuclide therapy on the quality of life of patients with prostate cancer with painful bone metastases
Sr-89 radionuclide therapy is an established alternative for the palliation of bone pain in prostate cancer. This study is to assess the Sr-89 radionuclide therapy on quality of life (QOL) in patients with prostate cancer and painful bone metastasis.
12-week, prospective, single-arm, open-label study
Three patients reduced their analgesic dosages within three months after Sr-89 treatment. No patients increased their analgesics dosages during the study period. According to the ECOG scale, performance status prior to the Sr-89 treatment was reported by the physician to be 0 or 1 in three patients (23.1%) and 2 or greater in the remaining 10 patients (76.9%). In the QLQ-C30, the mean score for global QOL was 29.9. Overall, there were no significant changes in patients' serum PSA and ALP after Se-89 therapy.
Using the EORTC QLQ-BM22 module, this study showed that Sr-89 therapy improves the comprehensive quality of life of patients with prostate cancer with bone metastases pain. This radionuclide therapy can provide not only reduced pain but also better psychosocial aspects and functional interference in this patient population.
Treatment with Sr-89 for prostate cancer with painful bone metastases could assist in pain management for this group of patients.
Kurita, G.P., Benthien, K.S., Nordly, M., Mercadante, S., Klepstad, P., Sjogren, P., & European Palliative Care Research Collaborative (EPCRC). (2015). The evidence of neuraxial administration of analgesics for cancer-related pain: A systematic review. Acta Anaesthesiologica Scandinavica, 59, 1103–1115.
STUDY PURPOSE: To review the evidence for the intraspinal administration of analgesics for refractory cancer-related pain
TOTAL REFERENCES RETRIEVED: 2,672
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A four-point quality scoring system was described.
PHASE OF CARE: End of life care
APPLICATIONS: Palliative care
Four studies compared combinations of opioids and adjuvant drugs to opioids alone. Two studies compared a neuraxial drug bolus with a continuous infusion, one study compared a single drug with a placebo, and two studies compared neuraxial drug administration with comprehensive medical management. Pain relief was reported in all studies comparing opioids alone or in combination with adjuvant drugs. Better analgesic effects were reported with continuous infusion compared to bolus infusion. Sample sizes were small, and the quality of the studies was low.
There was limited evidence regarding neuraxial analgesic administration for intractable pain in patients with cancer.
There were multiple methodologic concerns regarding study design and sample size. There were few studies for each type of study reviewed. Quality issues identified included loss to follow-up, unclear descriptions of setting, and no report of a power calculation. This review did not report sample sizes and graded items such as lack of setting description alone as equivalent to design issues.
There was limited evidence regarding the efficacy of intrathecal analgesic administration compared to other aggressive forms of pain control for patients with refractory pain, and the most effective drugs or drug combinations for this mode of delivery were not clear. Neuraxial treatment requires appropriate resources for safe administration and patient observation. Nurses have an important role to play regarding the selection of patients for safe home-based care delivery and the assessment of patient risks. Additional research comparing the efficacy of various aggressive pain management interventions is needed.
Kurdi, M.S., & Muthukalai, S.P. (2016). The efficacy of oral melatonin in improving sleep in cancer patients with insomnia: A randomized double-blind placebo-controlled study. Indian Journal of Palliative Care, 22, 295–300.
To conduct a randomized, double-blind, placebo-controlled efficacy study evaluating the effects of oral melatonin in improving sleep in patients with cancer experiencing symptoms of insomnia
The investigators randomized participants who consented into group A (melatonin) or group B (placebo) using a fishbowl technique. Melatonin (3 mg) or placebo (multivitamin tablet) was provided by a pharmacist. Tablets were similar in color (light yellow) and shape, and were wrapped in similar envelopes and given to participants. Instructions were to take tablets two hours prior to bedtime every day for 14 days. The Athens Insomnia Scale (AIS) was given by phone or in person on days 1, 7, and 14. Patients and evaluators were blinded to the drug group, and the group was revealed to research staff at the end of the study. Results were compared using a paired t test.
Prospective, randomized, double-blind, placebo-controlled study
The AIS self-assessment psychometric tool for measurement of sleep difficulty is an eight-item scale, and the first five items assess sleep induction, nighttime awakenings, final awakening, total sleep duration, and sleep quality. The remaining three items assess daytime well-being, functional capacity, and sleepiness. Items are scaled using 0–3 ratings, from 0 (no problem) to 3 (no sleep at all). The scale cut-off is 10 to predict outcomes.
Power for a sample size of 25 was verified (90% and alpha = 5%). No significant differences in demographic characteristics of age and sex existed (p > 0.05). Each group had one dropout. The sample was predominantly stage 1 (44% [group A], 40% [group B]) and stage 2 (32% [group A], 36% [group B]), and stage 3–4 was 24% in each group. The majority of subjects (54%) had head and neck cancer (e.g., tongue, larynx) followed by cervix cancer (12%), and 14% had ovarian, gastrointestinal, breast, and sarcomas. Group A had significantly improvements in sleep (p < 0.05) on the AIS at week 1 with intragroup improvements in group A in week 2 (p = 0.00001). The percent change in sleep improvement within group A was significant (p = 0.0001) but not significant in group B (p > 0.05).
The use of 3 mg of melatonin two hours prior to bedtime is an effective nonpharmacological treatment for increasing sleep induction and sleep quality in patients with cancer experiencing insomnia.
Additional large-scale randomized studies are needed to determine efficacy. Melatonin has emerging data to support the nonpharmacological treatment of sleep problems in patients with cancer.
Kundel, Y., Nasser, N.J., Purim, O., Yerushalmi, R., Fenig, E., Pfeffer, R.M., . . . Brenner, B. (2013). Phase II study of concurrent capecitabine and external beam radiotherapy for pain control of bone metastases of breast cancer origin. PloS One, 8, e68327.
To test the safety and efficacy of treatment with localized radiotherapy and capecitabine for management of painful bone metastases
Women with bone metastases from breast cancer received radiation with 30Gy in 10 fractions to cover all metastatic bone regions, given 5 days per week. Oral capecitabine at 1400mg/m2 was given 5 days per week, concurrently with radiation therapy. Patients were evaluated weekly during treatment and for every 4 weeks after treatment, for a total of 12 weeks after completion of treatment.
Phase-II, observational study
Side effects were mild. The most prevalent were nausea (33%), diarrhea (24%), weakness (21%), and mucositis (10%). The mean pain score decreased from 2.93 to 2.28 after one week (p < .002), to 1.45 after two weeks (p < .0001), and to 1.14 after four weeks (p < .01). Changes in pain scores after four weeks were not significant. Declines in analgesic use were noted during the first four weeks of treatment (p < .02) and were stabilized thereafter. The response rate was 31% at one week and 38% at 12 weeks. There were no differences between patients who did and did not receive bisphosphonates.
Combined radiation therapy with capecitabine was effective for the short-term reduction on pain from bone metastases with relatively mild side effects in the majority of subjects.
Combined radiation therapy and capecitabine may be a promising intervention for the palliation of painful bone metastases. Further research is needed to fully determine its efficacy and toxicity.