Langford, D. J., Lee, K., & Miaskowski, C. (2012). Sleep disturbance interventions in oncology patients and family caregivers: a comprehensive review and meta-analysis. Sleep Medicine Reviews, 16, 397–414.
To synthesize findings from intervention studies for sleep disturbance in patients with cancer and their caregivers.
Databases searched were PubMed, CINAHL, and PsycINFO.
Search keywords were sleep, sleep disturbance, insomnia, intervention, cancer, oncology, and caregivers.
Studies dated through 2010 that evaluated sleep disturbance/sleep quality as the primary or secondary outcome were included.
Intervention groupings analyzed via meta-analysis included cognitive-behavioral therapy (CBT), education, exercise, and complementary and alternative therapies. Effect sizes appeared to be slightly over 1.0 for CBT, close to 0 for education, slightly over 1.0 for exercise, and slightly over 0 for complementary and alternative therapies. Specific effect sizes were only shown graphically, and actual data were not presented. No separate analysis of caregiver effects could be determined. Modes of delivery of interventions varied widely across studies.
Findings suggest at least moderate effects of CBT and exercise for improvement in sleep disturbances for patients with cancer. No substantial effects of exercise and education were demonstrated.
The review was limited by the lack of any data regarding heterogeneity in the meta-analysis, variability of interventions, and modes of delivery to enable any firm conclusions.
Insufficient evidence was provided to draw any conclusions regarding intervention effects for caregivers.
Landier, W., & Tse, A.M. (2010). Use of complementary and alternative medical interventions for the management of procedure-related pain, anxiety, and distress in pediatric oncology: An integrative review. Journal of Pediatric Nursing, 25, 566–579.
To perform an integrative review of four electronic databases to determine the effectiveness of complementary and alternative medical (CAM) interventions, either alone or as an adjunct to pharmacologic therapy, in alleviating procedure-related pain, anxiety, and distress in children and adolescents with cancer
Databases searched were MEDLINE, CINAHL, PsycINFO, and Cochrane Database.
Search keywords were procedure, pain, anxiety, distress, childhood cancer, pediatric oncology, CAM, and complementary therapies.
Studies were included in the review if
Excluded from the review were studies that reported on surgical procedures (except percutaneous access to an implanted vascular device) and on the anxiety and distress of a parent.
Results suggest that mind-body intervention may be effective, alone or as an adjunct to pharmacologic interventions, in managing procedure-related pain, anxiety, and distress in pediatric patients with cancer. In this population the three most commonly studied mind-body modalities were distraction, hypnosis, and imagery.
Although multiple studies demonstrated the value of CAM interventions, many of the studies were small and incorporated multiple CAM therapies as a single intervention. These types of interventions may be useful, particularly when used in combination with pharmacologic agents, but further research is needed to identify which interventions were valuable.
Lambrecht, M., Mercier, C., Geussens, Y., & Nuyts, S. (2013). The effect of a supersaturated calcium phosphate mouth rinse on the development of oral mucositis in head and neck cancer patients treated with (chemo)radiation: A single-center, randomized, prospective study of a calcium phosphate mouth rinse + standard of care versus standard of care. Supportive Care in Cancer, 21, 2663–2670.
To investigate whether the addition of a neutral, supersaturated, calcium phosphate (CP) mouth rinse benefits the severity and duration of acute mucositis in patients with head and neck cancer treated with (chemo)radiation
Patients in group A were instructed to use caphosol mouth rinse twice daily with 15 ml solution for one minute plus standard care. Patients in group B were instructed to use standard care consisting of gargling with 15 ml of “magic mouth wash” (hydrocortisone, lidocaine, nystatin, propylene glycol, sodium carboxymethylcellulose, aqua admixture) up to six times per day, swallowing one time out of two. Two experienced physicians conducted visual inspection of the oral cavity and visualized oropharyns weekly until two to seven weeks after completion or until mucositis grade 1 or 0.
PHASE OF CARE: Active antitumor treatment
No significant differences were found in grade, time of onset, or duration of peak mucositis between groups. Fewer patients in the study arm experienced grade 3 or higher mucositis (59% versus 71%). Mean time to development of mucositis was 28.6 days in the study group versus 28.7 days in the control group (p = .96). Duration of mucositis was 22.7 days in the study group versus 24.6 days in the control group (p = .62). No significant reduction in the need for analgesics was found.
An oral solution of neutral CP mouth rinse does not reduce frequency, duration, or severity of oral mucositis or pain in patients treated with (chemo)radiation for head and neck cancer. No evidence supports its standard use.
Mucosal damage continues to be an important and debilitating side effect that warrants continued research.
Lambertini, M., Del Mastro, L., Bellodi, A., & Pronzato, P. (2014). The five “Ws” for bone pain due to the administration of granulocyte-colony stimulating factors (G-CSFs). Critical Reviews in Oncology/Hematology, 89, 112–128.
There was no real difference between pegfilgrastim and daily GCSFs in terms of incidence of bone pain, and most patients will benefit from the use of NSAIDs to control pain. The authors suggest that patients who do not respond to NSAIDs should consider second-line treatment with antihistamines. The study cites a series of four patients and one case study in which this was effective.
Only one study was cited that evaluated the efficacy of antihistamines in relieving or decreasing bone pain associated with GCSFs from 2005. Main evidence is case reports only.
More studies are needed to evaluate the efficacy of antihistamines versus NSAIDs or acetaminophen in relieving bone pain.
Lalla, R. V., Gordon, G. B., Schubert, M., Silverman, S., Jr, Hutten, M., Sonis, S. T., et al. (2012). A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy. Supportive Care in Cancer, 20, 1797-1804.
The purpose of this study was to determine if a misoprostol oral rinse would reduce the severity of mucositis in patients receiving high-dose chemotherapy for autologous stem cell transplant.
This multi-center study employed a randomized, double blind, placebo controlled, parallel-group design. Participants were assigned to the misoprostol arm or placebo arm. Subjects swished and gargled the misoprostol or placebo solution (in 15 ml of water), held it in their mouths for 60 seconds, and then swallowed. Administration began 45 min. to 2 hours before the initiation of the conditioning regimen and then every 8 hours until 24 hours after the conditioning regimen was complete. All subjects also received instructions on standard care and instructed not to use other oral care for 1 hour after the misoprostol or placebo solution. The Oral Mucositis Index was used to grade mucositis every 2 to 3 days.
The study was comprised of 48 patients, 22 in treatment arm and 26 in placebo group, with an age greater than or equal to 18 years.
MALES 30%, FEMALES 70%
KEY DISEASE CHARACTERISTICS: Lymphoma, multiple myeloma, or solid tumor patient undergoing autologous stem cell transplant.
OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have been receiving cisplantin/carboplatin conditioning regimens or total body irradiation.
SITE: Multi-site
SETTING TYPE: Inpatient
LOCATION: Six participating sites in the United States
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Palliative care
Randomized, double-blind, placebo-controlled, parallel group design
No statistically significant differences in Oral Mucositis Index scores. No statistically significant differences in the peak mucositis severity scores. No statistically significant differences in pain ratings, length of hospital stay, or days of total parenteral nutrition. There were no serious adverse events.
There was not a statistically significant benefit to using a misoprostol rinse in deterring the development or the severity of oral mucositis in patients undergoing autologous stem cell transplant. There was also no decrease in the length of stay or the use of total parenteral nutrition.
Small sample (<100)
Findings not generalizable
Other limitations/*explanation: The patient population was limited to only those cancer patients undergoing autologous stem cell transplant.
This study provides no evidence to support using a misoprostol mouth rinse to prevent the development of mucositis, decrease the severity of mucositis, decrease the length of stay, or decrease the use of total parenteral nutrition in patients undergoing a non-TBI based or non-cisplatin/carboplatin-based conditioning regimen for autologous stem cell transplant.
Lalla, R.V., Bowen, J., Barasch, A., Elting, L., Epstein, J., Keefe, D.M., ... Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). (2014). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer, 120, 1453–1461.
570 articles were included in this literature review. Literature contained prevention and/or treatment methods for mucositis. Interventions for treatment of mucositis were given, recommendations against an intervention were provided, suggestions in favor of an intervention were supplied, and suggestions against an intervention were given.
Recommendations included a combination of teeth brushing, flossing, mouth rinsing, and use of growth factors and cytokines in treatment of mucositis. The use of anti-inflammatory agents was also recommended. Low level laser therapy was recommended in prevention of mucositis with specific types of cancer treatment. Cryotherapy was also recommended for patients receiving chemotherapy. A list of natural and miscellaneous agents was recommended for treatment and prevention of mucositis.
Limitations of this study include clinical situations that were not seen in the literature review or that are rare in clinical settings. These limitations occur because of conflicting evidence or not enough evidence provided.
Nurses should be assessing patients' pain control, nutritional support, ability to eat, and oral hygiene practices, and should be teaching on the use of oral care products that are essential for prevention.
Lalla, R.V., Choquette, L.E., Curley, K.F., Dowsett, R.J., Feinn, R.S., Hegde, U.P., . . . Peterson, D.E. (2014). Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis in patients receiving radiation therapy for head and neck cancer. Oral Oncology, 50, 1098–1103.
To investigate the effects of cyclooxygenase-2 (COX-2) inhibition on the severity and morbidity or oral mucositis in patients with head and neck cancer undergoing radiation based on the role of inflammatory pathways in oral mucositis pathogenesis
Patients were randomized using a one-to-one ratio in blocks of 10 to receive either celecoxib or a placebo. The celecoxib and placebo capsules were identical. The first four patients took 200 mg of celecoxib twice per day beginning five days prior to the first day of radiation therapy and continuing for three days after the conclusion of radiation therapy. Dosing was modified for all subsequent patients to 200 mg of oral celecoxib once per day only on the days of radiation therapy from the first to the last day of therapy. Subsequent patients assigned to the control arm took the placebo once per day for the same duration. Data were collected two to three times per week for the six to seven weeks during which radiation occurred.
Prospective, randomized, double-blinded, placebo-controlled, parallel-arm trial
There was no difference in oral mucositis severity between the celecoxib and placebo groups (p = .67).
The use of a COX-2 inhibitor during radiation in patients with head and neck cancer did not reduce the severity of clinical oral mucositis, mouth pain, dietary compromise, or use of opioid analgesics. This study’s power calculation seems to be weak. The dropout and missing data rate (usually 20%) should be added to satisfy the original power calculation. This increases the significant risk of type II error. Without a study with a larger sample size, this practice cannot be recommended.
This is not an effective option for treating radiation-induced mucositis.
Lalami, Y., Paesmans, M., Aoun, M., Munoz-Bermeo, R., Reuss, K., Cherifi, S., . . . Klastersky, J. (2004). A prospective randomised evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia. Supportive Care in Cancer, 12, 725–730.
The study focused on the secondary prevention of febrile neutropenia with G-CSF and antibiotics.
G-CSF (5 mcg/kg subcutaneous) or G-CSF with antibiotics (ciprofloxacin 500 mg by mouth every eight hours and amoxicillin 500 mg by mouth or clavulanate 125 mg by mouth every eight hours) daily starting 48 hours after chemotherapy and continuing until the absolute neutrophil count is greater than 2,000 cells/mm³. Patients were included in the study for one treatment cycle.
Two sites in Europe.
Prospective, randomized pilot trial.
Patients were evaluated with:
In the event of a fever, the antibiotic prophylaxis was discontinued and a complete clinical evaluation for infection was completed.
No episodes of febrile neutropenia occurred in the G-CSF group, and only one incident of febrile neutropenia was reported in the combined group (p = 1). Reported side effects were similar and mild.
G-CSF reduced the risk of febrile neutropenia recurrence. Antibiotics did not provide any additional benefit in terms of prophylaxis.
Lajolo, P.P., De Camargo, B., & Del Giglio, A. (2009). Omission of day 2 of antiemetic medications is a cost saving strategy for improving chemotherapy-induced nausea and vomiting control results of a randomized phase III trial. American Journal of Clinical Oncology, 32, 23–26.
To evaluate the effect of omitting day 2 administration of granisetron in the treatment of chemotherapy-induced nausea and vomiting (CINV)
The study was conducted at a single outpatient setting in Brazil.
All patients were in active treatment.
This was a randomized, placebo-controlled, double-blind trial.
Differences in rates of complete protection from nausea and vomiting in this study were unclear and difficult to interpret because different groups experienced better CINV control at different time points.
No clear conclusions can be drawn from this study.
Lajolo, P.P., & del Giglio, A. (2007). Skipping day 2 antiemetic medications may improve chemotherapy induced delayed nausea and vomiting control: Results of two pilot phase II trials. Supportive Care in Cancer, 15(3), 343-346.
To evaluate whether skipping day 2 antiemetic medications may improve delayed chemotherapy-induced nausea and vomiting (CINV), based on the hypothesis that repeated consecutive doses of antiemetics may lead to increased accumulation of 5-HT3 at the presynaptic level in the gastrointestinal (GI) tract, decreasing the activity of the next dose of a 5-HT3 receptor antagonist (tachyphylaxis)
Patients were given day 1 antiemetics according to American Society of Clinical Oncology (ASCO) guidelines. Patients in Study 1 received 10 mg metochlopramide by mouth every eight hours, 0.05 mg granisetron by mouth four times per day, and 8 mg dexamethasone four times per day on days 2 and 3. In Study 2, patients received the same medications except that no drugs were given on day 2. Patients recorded emetic episodes in diaries and responded to a quality-of-life (QOL) questionnaire at baseline and on day 6.
The studies were conducted in the hematology and oncology department of a School of Medicine in Brazil.
This research consisted of two pilot studies.
The Functional Living Index of Vomiting (FLIE) was used.
Skipping day 2 antiemetic medications does not seem to worsen delayed CINV and may reduce CINV.
Study limitations include the use of a nonrandomized design and the small sample size.