Yahata, H., Kobayashi, H., Sonoda, K., Shimokawa, M., Ohgami, T., Saito, T., . . . Kato, K. (2016). Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen: A multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin. International Journal of Clinical Oncology, 21, 491–497.
To evaluate the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) and hypersensitivity reactions in patients with gynecologic cancer who are receiving paclitaxel and carboplatin
All patients received either 1 mg of granisetron or 4 mg of ondansetron and 20 mg of dexamethasone IV on day 1. Patients in the placebo group received a placebo on days 1–3, and patients in the aprepitant group received 125 mg of aprepitant PO on day 1 and 80 mg of aprepitant PO on days 2 and 3.
PHASE OF CARE: Active antitumor treatment
This was a randomized, double-blind, placebo-controlled study.
Hypersensitivity reactions were graded using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. From days 1–5, patients recorded the highest level of nausea severity each day (absent, mild, moderate, severe), number of episodes of emesis, and time of each episode. Patients also recorded the date and time of each rescue antiemetic and responses to questions about appetite. Adverse effects were graded using CTCAE, version 4.0.
The rates of hypersensitivity reactions were similar in the control and test groups. Patients who received aprepitant, when compared to the control group, had higher rates of no vomiting in the overall phase and during the acute and delayed phases (p < 0.0001, p < 0.0001, p = 0.0495). The rate of \"no significant nausea\" was also significantly higher in the aprepitant group in the overall phase and delayed phase (p = 0.0143, p = 0.0274). Complete response (no vomiting and no rescue medication) was significantly higher in the aprepitant group in the overall and delayed phases (p = 0.0073, p = 0.0072).
Aprepitant is beneficial when used in combination with a 5-HT3 receptor antagonist and dexamethasone in patients with gynecologic cancer receiving paclitaxel and carboplatin.
Aprepitant may be given as CINV prophylaxis for patients receiving paclitaxel and carboplatin for the treatment of gynecologic cancer.
Yagli, N.V., Sener, G., Arikan, H., Saglam, M., Inal Ince, D., Savci, S., . . . Ozisik, Y. (2015). Do yoga and aerobic exercise training have impact on functional capacity, fatigue, peripheral muscle strength, and quality of life in breast cancer survivors? Integrative Cancer Therapies, 14, 125–132.
Patients were randomized to a yoga plus exercise group or an exercise alone group. Both groups did aerobic exercises three days per week for six weeks. The yoga program involved postures, meditation, and relaxation with imagery. Yoga was provided in 60-minute group sessions three days per week on the same day as exercise was done. Yoga was supervised by a certified therapist.
Randomized, controlled trial
Aerobic exercise training and yoga improved functional capacity and QOL and reduced fatigue in patients with breast cancer. The addition of yoga to aerobic exercise was associated with greater improvements in fatigue perception and QOL measures.
The findings of this study suggest that the addition of yoga to exercise interventions may cause improvements in perception of dyspnea and fatigue among breast cancer survivors that are greater than the effects of exercise alone. Mind–body approaches should be considered as adjuvant interventions for fatigue.
STUDY PURPOSE: To determine the prophylactic effects of honey on radiation- and chemotherapy-induced mucositis
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Active antitumor treatment
Honey treatment reduced the incidence of oral mucositis in the honey group by 65% compared to the control group. The type of radiation therapy (source, dose) may have influenced the results.
Mostly low quality/high risk of bias studies
Honey prevents the incidence of mucositis compared to no intervention. However, more randomized, controlled trials are needed to determine the prophylactic effects of honey on patients receiving radiation or radiation and chemotherapy.
Xu, X.T., Dai, Z.H., Xu, Q., Qiao, Y.Q., Gu, Y., Nie, F., . . . Ran, Z.H. (2013). Safety and efficacy of calcium and magnesium infusions in the chemoprevention of oxaliplatin-induced sensory neuropathy in gastrointestinal cancers. Journal of Digestive Diseases, 14, 288–298.
STUDY PURPOSE: To identify all observational studies that examine the role of calcium and magnesium infusions in the chemoprevention of oxaliplatin-induced sensory neuropathy in gastrointestinal cancers
DATABASES USED: PubMed, EMBASE, Science Citation Index, Expanded Chinese National Knowledge Infrastructure
KEYWORDS: Calcium gluconate; digestive system neoplasms; magnesium sulfate; neurotoxicity syndrome; oxaliplatin; oxaliplatine; eloxatine; ACT 078 L-HP; neuropathy; chemotherapeutic agent; toxicity; calcium; Ca; Ca and magnesium; Mg or Mg and oesophageal cancer; gastric cancer; stomach cancer; bowel cancer; colorectal cancer; colon cancer; rectal cancer; pancreatic cancer; hepatocellular carcinoma; liver cancer; biliary tract cancer
INCLUSION CRITERIA: Studies for meta-analysis included randomized, controlled trials and cohort studies that involved calcium and magnesium infusions in chemoprevention of oxaliplatin-induced sensory neurotoxicity in gastrointestinal cancers.
EXCLUSION CRITERIA: Letters, case studies, reviews, comments, studies on cell lines, animal studies, and any study with no control group
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: National Cancer Institute Common Toxicity Criteria (NCI CTC) and oxaliplatin-specific scale (OSS) were used. Meta-analysis was done on six studies that had reported responses. A sensitivity analysis was used by repeating meta-analysis but excluding one study at a time. Odds ratio and its 95% confidence interval were calculated.
The difference in the incidence of grade 1 oxaliplatin-induced neuropathy was statistically significant between those who received calcium and magnesium infusions and those who did not receive the treatment (NCI CTC: OR .44, 95% CI 0.31–0.62, p = 0.000; OSS: OR 0.30, 95% CI 0.20–0.45, p = 0.000). Similar results were found in the incidence of grade 2 oxaliplatin-induced neuropathy (NCI CTC: OR 0.60, 95% CI 0.46–0.77, p = 0.000; OSS: OR .45, 95% CI 0.30–0.67, p = 0.000). No difference was observed in grade 3 neuropathy in patients treated with calcium and magnesium infusions opposed to those who were not treated with calcium and magnesium infusions (NCI CTC: OR 0.67, 95% CI 0.44–1.01, p = 0.054; OSS: OR 0.66, 95% CI 0.34–1.29, p = 0.224). Overall, calcium and magnesium infusions reduced the incidence of peripheral neuropathy grades 1 and 2. This did not include the incidence of grade 3 neuropathy. The calcium and magnesium infusions did not lessen the treatment effects of oxaliplatin (OR 0.89, 95% CI 0.67–1.17, p = 0.391).
Most research in chemotherapy-induced peripheral neuropathy has focused on treatment-related side effects. Positive studies in this area are lacking. However, this analysis of six studies of calcium and magnesium infusions in the prevention of chemotherapy-induced peripheral neuropathy is promising. Large, randomized trials would need to be done to determine efficacy.
One of the limitations speaks to lack of consistency among various assessment scales for peripheral neuropathy. Whether a preventive study or treatment study, assessment is critical to patients with peripheral neuropathy. Nurses should be knowledgeable concerning various assessment scales and should use the scales from baseline through survivorship.
Xu, Y., Chen, Y., Li, P., & Wang, X.S. (2015). Ren Shen Yangrong Tang for fatigue in cancer survivors: A phase I/II open-label study. Journal of Alternative and Complementary Medicine, 21, 281–287.
To establish the safety and efficacy of traditional Chinese herbal medicine for the treatment of fatigue in patients with cancer who do not have anemia
Patients were recruited from those who visited a herbal medicine clinic. Patients were given a combination of 12 herbs, which they slowly cooked in 150 ml of water. This decoction was taken twice daily for six weeks. Study measures were obtained at baseline and after six weeks. Patients were evaluated by a traditional Chinese medicine doctor at the beginning and end of the study.
Open-label phase I–II
Fatigue levels declined during the study (p = 0.024), and 64% of patients said they felt better within two weeks, and 33% felt better after three weeks. No adverse events were reported.
The findings of this study suggest that that a traditional Chinese herbal medicine formulation appears to be safe and may be helpful in the treatment of depression among patients with cancer.
This study was limited by design and sample size, so no firm conclusions about the safety and efficacy of traditional Chinese herbal medicine can be made.
Xu, L., Lao, L.X., Ge, A., Yu, S., Li, J., & Mansky, P.J. (2007). Chinese herbal medicine for cancer pain. Integrative Cancer Therapies, 6, 208–234.
To summarize and evaluate the state of clinical research on the use of Chinese herbal medicine in the treatment of cancer-related pain
The type of article is systematic review.
Databases searched were Chinese Biomedical Literature, Chinese Medical Current Content, Wanfang, and Weipu databases in Chinese, and PubMed and EMBASE in English.
Search keywords were Chinese herb, Chinese medicine and neoplasms and pain. Specific search terms in English and Chinese are displayed in this report.
Studies were included in the review if they were reports of original work on cancer-related pain.
Reviews, commentary, abstracts, and reports on pain associated with cancer therapies were excluded.
An initial search provided 212 Chinese articles and 161 articles from English literature.
Study quality was evaluated using the National Cancer Institute’s Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine guidelines.
Results are organized according to route of administration: oral, IV, and other methods of application, such as inhalation.
Treatment Outcomes
External application: This is the most common use. This area included 41 studies
Oral administration: 48 studies were in this category. Comparison positive controls in this group tended to also be palliative chemotherapy or radiation therapy, NSAIDs, and opioids. Dosage ranges of comparison medications were not discussed.
IV infusions: 23 studies were reported; however, authors included studies of intramuscular administration, and samples being actively treated with chemotherapy or radiotherapy for pain. Overall positive results compared to placebo or no active controls were reported.
Other administration methods: One study involving inhalation and one involving per rectum administration are discussed.
Adverse Reactions: Adverse events were slight and brief, and in most cases patients did not require further intervention. Adverse effects were reported to be higher in conventional medicine control groups.
The authors conclude that Chinese herbal medicine may be useful for managing cancer pain. However, there is no discussion of the fact that control comparisons used were no specific pain treatment, or low-level interventions such as NSAIDs. In this regard, controls used in the research summarized here were insufficient to provide realistic scientific comparisons. Methods of pain measurement reported here show mostly use of a single pain measure such as various verbal reporting scales, which can be expected to influence reliability and validity of individual study results. The authors point out that the quality of studies, design and methods, and study reporting was low. The authors suggest specific approaches in study design for improvement of research in this area.
Well-designed research in the use of Chinese herbal medicine is needed to enable firm conclusions about efficacy. Research regarding the role of this type of treatment as adjunctive pain management would also be useful. Findings here provide only minimal support for the use of Chinese herbal medicine to effectively manage cancer-related pain.
Xing, S.Z., & Zhang, Y. (2015). Efficacy and safety of transdermal fentanyl for the treatment of oral mucositis pain caused by chemoradiotherapy in patients with esophageal squamous cell carcinoma. Supportive Care in Cancer, 23, 753–759.
To investigate the efficacy and safety of transdermal fentanyl for mucositis pain caused by chemoradiotherapy in patients with esophageal squamous cell carcinoma
Forty-six patients with moderate to severe oral mucositis receiving chemoradiotherapy for esophageal squamous cell carcinoma were given transdermal fentanyl for pain management.
This was an unblinded, nonrandomized study.
Pain scores on a Numeric Rating Scale (NRS), the National Cancer Institute's Common Toxicity Criteria, administration frequency of transdermal fentanyl, and post-treatment adverse effects data were analyzed using SPSS. The paired sample Wilcoxon signed rank test was used to evaluate differences before and after treatment, quality of life, nutritional status, and oral hygiene.
The NRS pain scores were p < 0.0001 before and after treatment. Significant differences (p < 0.001) were observed between the indices of quality of life. 15.2% of patients reported nausea and vomiting, 13% developed dizziness, and 10.9% complained of gastric discomfort. All these symptoms were mild and disappeared after proper management.
In this study, transdermal fentanyl was effective in reducing pain from oral mucositis caused by chemoradiotherapy.
Nurses should be aware of the benefits of transdermal fentanyl but also should be aware of its side effects and half-life so they can educate and support patients in pain.
Xin'an, L., Jianying, Z., Lizhi, N., Fei, Y., Xiaohua, W., Jibing, C., . . . Kecheng, X. (2014). P0079 alleviating the pain of unresectable hepatic tumours by percutaneous cryoablation: Experience in 73 patients. European Journal of Cancer, 50(Suppl. 4), E31.
To review the changes in the severity of pain before and after percutaneous cryoablation of hepatic tumors
Patients with large tumors (major diameter P5 cm) underwent transarterial chemoembolization (TACE) first and then cryoablation. Cryosurgeries of hepatic tumors were performed on all 73 patients using an argon gas-based cryosurgical unit with two freeze/thaw cycles. Maximal freezing time was 15 minutes followed by natural thawing for 5 minutes x 2. A margin of at least 1 cm of normal hepatic tissue was frozen circumferentially around the tumor.
Six patients had an immediate relief of severe pain, 11 had relief within 15 days of cryosurgery (these were of the 17 patients with pain prior to the procedure), 39 were always pain-free, and 17 had new pain with the procedure but total relief within 15 days.
The pain-relieving effect of cryosurgery was immediate for some patients but all eventually experienced the complete disappearance of pain for at least eight weeks. Pain relief was delayed for some patients due to edema, which resulted from the treatment.
Cryoablation is a potential pain-relieving treatment for primary and metastatic tumors of the liver, but more studies are needed before this can be recommended as a modality to manage pain. Evidence to support long-term results beyond eight weeks also is lacking.
Xie, J., Chen, L.H., Ning, Z.Y., Zhang, C.Y., Chen, H., Chen, Z., . . . Zhu, X.Y. (2017). Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: A single-blind, randomized, controlled trial. Chinese Journal of Cancer, 36, 6-016-0176-1.
To investigate the effects of transcutaneous electrical acupoint stimulation (TEAS) on chemotherapy-induced nausea and vomiting (CINV)
Patients receiving chemotherapy via an infusion to transcatheter arterial chemoembolization were randomized to an active or placebo acupuncture group. Prior to chemotherapy, all patients received IV palonosetron. Patients received acupuncture 1–2 hours before chemotherapy, and more just after chemotherapy. Acupuncture was continued twice daily for six days. In the sham acupuncture group, electrodes were placed on the same acupoints for the same length of time and frequency, but no electrical stimulation was given. Severity and frequency of nausea and vomiting were recorded in patient diaries daily. P6, L14, and ST36 acupoints were used.
PHASE OF CARE: Active antitumor treatment
Double-blind, sham-controlled, randomized, controlled trial
No significant differences in CINV existed between groups. Anorexia was lower in the active acupuncture group from the second day onward (p < 0.0002).
Electroacupuncture was not shown to have an effect on CINV but appeared to have benefit for reducing anorexia.
Electroacupuncture was not effective in reducing CINV in this study but appeared to have a positive effect on appetite. Additional research is needed to determine any potential role of acupuncture for anorexia in patients with cancer.
Xiao, F., Song, X., Chen, Q., Dai, Y., Xu, R., Qiu, C., & Guo, Q. (2016). Effectiveness of psychological interventions on depression in patients after breast cancer surgery: A meta-analysis of randomized controlled trials. Clinical Breast Cancer. Advance online publication.
STUDY PURPOSE: To assess the effectiveness of Cognitive Behavioral Therapy (CBT) or CBT approach interventions for improving depressive symptoms
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Not specified or not applicable
Analysis was conducted for each type of outcome measurement instrument used in the research. Across eight studies using the Self-Rating Depression Scale (SDS), the effect of the intervention was seen to be beneficial (standard mean difference [SMD] = –0.87, p < 0.0001). The pooled results of three studies for effects using the Hospital Anxiety and Depression Score (HADS) was also in favor of the intervention (SMD = –0.50, p = 0.04). Across all studies, the SMD comparing CBT to control was –0.92 (p < 0.00001).
Individually delivered CBT was shown to be effective in reducing the symptoms of depression among women with breast cancer.
In some studies, different cognitive behavioral approaches were used, and some delivered the intervention via a combination of face-to-face and telephonic contact. The results of the study quality evaluation were not reported. All studies excluded patients with major depression diagnoses.
Interventions using cognitive behavioral approaches can be effective to reduce the symptoms of depression in women having undergone surgery for breast cancer. Although full CBT is generally delivered by trained therapists, nurses can incorporate many of these principles into general patient teaching, counseling, and support. Patients with significant depression should be referred for appropriate management as needed.