Maccio, A., Madeddu, C., Gramignano, G., Mulas, C., Floris, C., Sanna, E., . . . Mantovani, G. (2012). A randomized phase III clinical trial of a combined treatment for cachexia in patients with gynecological cancers: Evaluating the impact on metabolic and inflammatory profiles and quality of life. Gynecologic Oncology, 124, 417–425.
To compare the efficacy and safety of (arm 1) combined treatment with L-carnitine (4 g/day) plus celecoxib (300 mg/day) plus antioxidants (lipoic acid 600 mg/day, carbocysteine 2.7 g/day) plus megestrol acetate (MA) 320 mg/day versus (arm 2) MA 320 mg/day alone (considered standard of care) for the treatment of advanced neoplastic disease-associated symptoms in gynecologic patients with progressive or recurrent disease previously treated with one or more lines of chemotherapy
Primary endpoints included increase in lean body mass (LBM), decrease in resting energy expenditure (REE), decrease in fatigue, and an improvement in global quality of life (QOL). Secondary endpoints included appetite, grip strength, Glasgow Prognostic Score (GPS), Eastern Cooperative Oncology Group (ECOG) performance score, and serum markers of inflammation and oxidative stress: C-reactive protein (CRP), interleukin 6 (IL-6), tumor necrosis factor (TNF), leptin, reactive oxygen species (ROS), glutathione peroxidase (GPx), and superoxide dismutase (SOD).
Baseline anthropometric measures, physical examination, vital signs, tumor site, stage, chemotherapy regimen, weight loss in previous three to six months, performance status, Glasgow Prognostic Score, and QOL were assessed. After baseline assessment, randomization was completed by a biostatistician to arm 1 or arm 2. Treatment duration was planned for four months. All patients received 150 UI/kg of low molecular weight heparin subcutaneously for the treatment duration. Endpoints were assessed at baseline (before treatment) and at 4, 8, and 16 weeks, although all analysis was presented as a comparison between baseline and 16 weeks. Safety was monitored with weekly evaluations of adverse events and toxicity. All patients also received psychosocial counseling.
This multisite study was conducted in an inpatient setting in Italy.
This was an open-label, randomized, controlled, prospective study.
Groups were similar in patient characteristics. At 16 weeks, LBM increased significantly (p = 0.032) in arm 1 with a mean difference of +4.65 kg compared to arm 2. REE changes were decreased significantly in arm 1 (p = 0.046) compared to arm 2. Arm 1 had significant decreases in fatigue symptoms (p = 0.049) and a higher mean QOL score (p = 0.042) compared to arm 2. Arm 1 gained a significant amount of weight with a mean increase of 0.5 kg per week over 16 weeks (p = 0.002). REE and fatigue decreased in arm 1 significantly at 16 weeks but not in arm 2. Both arms had significantly increased appetite (p < 0.05) and decreased ECOG scores. There was no difference between groups in appetite. Serum markers for inflammation and oxidative stress decreased significantly in arm 1 at 16 weeks. No significant arm 2 findings resulted. Leptin increased significantly in arm 1 and moderately but nonsignificantly in arm 2. Two patients had grade 3 diarrhea in arm 1.
The multimodal arm (arm 1) had improved physical, inflammatory, oxidative stress markers and QOL compared to MA alone, but did not appear to make a difference in appetite.
Study findings support multimodal approaches, including psychosocial support, for symptom management. More work should include patient-reported outcomes, toxicity, and safety of the intervention.
Annino, L., Chierichini, A., Anaclerico, B., Finolezzi, E., Norata, M., Cortese, S., . . . Girmenia, C. (2013). Prospective phase II single-center study of the safety of a single very high dose of liposomal amphotericin B for antifungal prophylaxis in patients with acute myeloid leukemia. Antimicrobial Agents and Chemotherapy, 57, 2596–2602.
To evaluate the feasibility and tolerability of prophylactic administration of a single, very high dose of liposomal amphotericin B (L-AmB) in adult patients newly diagnosed with acute myeloid leukemia (AML) and undergoing induction chemotherapy
The study was a pilot, phase II, single-center trial. The L-AmB was used to evaluate its efficacy and the level of toxicity. The study enrolled patients with AML undergoing first remission induction chemotherapy from January 2004–January 2011.
Overall, 18 of the 48 (37.5 %) patients experienced at least one adverse effect (all CTC grade) after the first or second L-AmB, and only six of them (12.5%) reported CTC grade 3 adverse events related to L-AmB administration.
The study demonstrates the feasibility and safety of a single, very high dose of L-AmB as antifungal prophylaxis in patients with AML undergoing induction chemotherapy.
This study basically determines the use of L-AmB to be used safely in patients with AML undergoing induction chemotherapy and does not have enough specification related to nursing.
Anghelescu, D.L., Faughnan, L.G., Hankins, G.M., Ward, D.A., & Oakes, L.L. (2010). Methadone use in children and young adults at a cancer center: A retrospective study. Journal of Opioid Management, 7, 353–361.
To augment the literature on methadone applications in pediatric oncology
This was a retrospective review of all patients treated with methadone at St. Jude Children’s Research Hospital over a five-year period (October 2001–September 2006).
Methadone dosing data were available for 37 patients. Four patient records lacked baseline doses because methadone was initiated at another institution. Starting doses ranged from 0.06–3.8 mg/kg/d. The highest methadone dose was 9.4mg/kg/d. More than one-third of the patients (34.1%) had no documented adverse effects. The most common adverse effect was sedation (24.4%). No respiratory depression or pruritus were documented. Pain reduction was reported by comparing the maximum pain score on the day that methadone was discontinued to the maximum pain score on the day that methadone was initiated. Fourteen of the 41 patients had documented pain scores for both time points. Nine patients (64.3%) showed reduction of the pain score, and seven (50%) had complete resolution of pain.
Methadone was effective for pediatric patients with neuropathic pain or nociceptive pain unresponsive to other opioids, and it effectively prevented opioid withdrawal.
Prospective studies are needed to evaluate specific methadone regimens for each of the clinical entities described and to determine opioid conversion scales to and from methadone in the pediatric population.
Ando, M., Morita, T., Akechi, T., Ito, S., Tanaka, M., Ifuku, Y., & Nakayama, T. (2009). The efficacy of mindfulness-based meditation therapy on anxiety, depression, and spirituality in Japanese patients with cancer. Journal of Palliative Medicine, 12, 1091–1094.
To assess the efficacy of mindfulness-based meditation therapy on the anxiety, depression, and spiritual well-being of Japanese patients undergoing anticancer treatment
Researchers used a modified version of the Mindfulness-Based Stress Reduction (MBSR) Program. The modification focused on cyclic mediation (breathing and meditation). Each session lasted 30–60 minutes and was conducted by nurses or a clinical psychologist. The first session consisted of the cyclic mediation program and recommendations to perform the mediation at home once daily, using a CD or DVD. After two weeks the patients met with interviewers and discussed impressions.
Pre- and postintervention questionnaire
The mindfulness-based intervention as provided in this study was associated with decreased anxiety and depression.
Nursing interventions that can help reduce the anxiety and depression of cancer treatments need exploration. More studies that result in reproducible measures are needed.
Ando, Y., Hayashi, T., Ito, K., Suzuki, E., Mine, N., Miyamoto, A., . . . Yamada, S. (2016). Comparison between 5-day aprepitant and single-dose fosaprepitant meglumine for preventing nausea and vomiting induced by cisplatin-based chemotherapy. Supportive Care in Cancer, 24, 871–878.
To compare the five-day administration of aprepitant with a single administration of fosaprepitant meglumine to prevent chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy regimens containing cisplatin
Participants were randomly assigned to receive a five-day course of aprepitant or a single administration of fosaprepitant meglumine. CINV was monitored for seven days after the first administration of chemotherapy.
Randomized, controlled trial
When CINV was compared, five days of aprepitant versus a single administration of fosaprepitant meglumine did not yield statistically significant results.
Five days of aprepitant for five days and a single administration of fosaprepitant meglumine had similar outcomes in regard to the prevention of CINV.
In this study, one dose of fosaprepitant meglumine had similar effects on CINV as five-day aprepitant. One dose of a medication is more cost effective and reduces patient medication burden, so this may be a preferable treatment alternative.
Ando, M., Morita, T., Okamoto, T., & Ninosaka, Y. (2008). One-week Short-Term Life Review interview can improve spiritual well-being of terminally ill cancer patients. Psycho-Oncology, 17, 885-890.
To assess the efficacy of a Short-Term Life Review process on spiritual well- being, anxiety, depression, suffering, and happiness in terminally ill patients with cancer
The intervention was Short-Term Life Review completed with a psychologist, who then created an album based on the participant’s interview. In the first part, participants reviewed their life, and in the second, they reevaluated, reconstructed, and appreciated their life. In the second session, the album was reviewed with the participant.
A prospective pre/post-test design was used.
Anxiety and depression scores significantly decreased (p = 0.001).
The Short-Term Life Review process is feasible for terminally ill patients and appears to be beneficial to reduce anxiety and depression, reduce suffering, and improve happiness.
Ando, M., Morita, T., Akechi, T., Ito, S., Tanaka, M., Ifuku, Y., & Nakayama, T. (2009). The efficacy of mindfulness-based meditation therapy on anxiety, depression, and spirituality in Japanese patients with cancer. Journal of Palliative Medicine, 12,1091–1094.
To determine the effects of a mindfulness intervention on anxiety, depression, and spirituality
The intervention involved 30–60-minute cyclic meditation and yoga training with practice at home. In pretherapy sessions, patients learned the cyclic meditation program and were recommended to perform the therapy at home once daily. After two weeks, patients met therapists in a second session to talk about their impressions.
Patients were undergoing the active treatment phase of care.
A pre/post-intervention study design was used.
Anxiety (p = 0.01) and depression (p = 0.009) decreased significantly. There was no significant change related to spirituality. Spirituality is correlated with anxiety and depression.
Mindfulness-based cyclic meditation affects anxiety and depression for Japanese patients with cancer and may be effective as an individual short-term therapy.
This type of intervention may be helpful to some patients to affect anxiety and depression during cancer treatment. The amount of training required for administration of the therapy, as well as therapist time with the patient, suggests that this approach may be feasible.
Anderson, K.O., Cohen, M.Z., Mendoza, T.R., Guo, H., Harle, M.T., & Cleeland, C.S. (2006). Brief cognitive-behavioral audiotape interventions for cancer-related pain: Immediate but not long-term effectiveness. Cancer, 107(1), 207–214.
To evaluate the effect of three brief cognitive behavioral interventions as adjunct treatment for chronic cancer-related pain
Patients were randomly assigned to one of four groups: relaxation, distraction, positive mood, or wait-list control. Patients in the relaxation, distraction, and positive-mood groups received audiotapes and instructions to practice a specific psychoeducational technique at least five times weekly.The relaxation group received a 20-minute audiotape providing standard progressive muscle relaxation instructions. Patients in the distraction group selected an audiotape on a topic such as history, foreign language, or geography. Patients in the positive-mood group received audiotapes of positive-mood statements and positive-imagery suggestions. The research nurse telephoned all patients periodically to answer questions and encourage use of the assigned tapes. Patients completed assessments at baseline and in weeks 2–3, weeks 4–5, and weeks 8–9. For the first seven weeks, patients rated pain, according to a visual analog scale (VAS), before and after using the audiotapes.
Randomized controlled trial
Subjects in the distraction and control groups reported a significant decrease (p < 0.05) in worst pain severity from baseline to follow-up at 2–3 weeks. Subjects in the positive-mood and control groups reported a significant decrease (p < 0.05) in BPI average pain score from baseline to the follow-up at 2–3 weeks. Analysis of mailed data showed that patients in the distraction group reported a mean reduction in pain severity of 1.16 (p = 0.004) and that, after listening to the tapes, patients in the relaxation group reported a mean reduction in pain severity of 0.9 (p = 0.023). Patients in the positive-mood group reported a nonsignificant increase in pain severity after audiotape use. Authors noted no differences between groups after 2–3 weeks. Authors noted no intervention effects on quality of life, mood, or perceived self-efficacy. There were no differences between groups in pain interference scores from the BPI. More than one-half the patients reported using the audiotapes at least five times per week. More than one-half the patients dropped out of the study or were lost to follow-up; 25% of these withdrew prior to the first follow-up assessment, at 2–3 weeks. The most common reasons for withdrawal were ineffectiveness of intervention and disease progression.
Distraction and relaxation audiotapes appeared to produce immediate short-term decreases in pain intensity. However, authors observed no long-term effects and no overall differences between intervention groups and the control group.
The findings of this study do not support the use of the specified techniques with audiotapes and minimal direct patient contact via telephone. This study does not add to knowledge regarding full cognitive behavioral techniques, because this study did not include many aspects typical of these techniques.
Anderson, R.T., Kimmick, G.G., McCoy, T.P., Hopkins, J., Levine, E., Miller, G., . . . Mihalko, S.L. (2012). A randomized trial of exercise on well-being and function following breast cancer surgery: The RESTORE Trial. Journal of Cancer Survivorship: Research and Practice, 6(2), 172–181.
To determine the effectiveness of early exercise intervention programs on the quality of life, physical function, and arm volume for breast cancer survivors immediately following breast cancer surgery
Participants were randomized into a control group and an intervention group. The control group received patient education only (tips about lymphedema awareness and prevention exercises from a general newsletter). The intervention group underwent a tailored comprehensive program (the RESTORE program), which consisted of a structured exercise regimen, a lymphedema prevention module, patient and diet education, and counseling sessions. The intervention occurred every 3 months, beginning from 4–12 weeks after breast cancer treatment. The final session occurred at 18 months.
The study took place across multiple in-patient and home settings in association with Wake Forest University Health Center.
Patients were undergoing transition from breast cancer treatment to active treatment for lymphedema.
The study used a single, blinded, randomized controlled design.
The effectiveness of the RESTORE program was measured using the Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B), distance traveled during a six-minute walk (measured by a pedometer), and arm volumes measured at three-month intervals using the water displacement method. The FACT-B was a survey that assessed physical, social, and functional well-being of the participants.
Those in the exercise intervention had a significantly higher distances walked in the six-minute walk test than in the control group by the end of all the study (p = 0.00098). However, there was no statistical difference between the average FACT-B scores from the control and intervention groups. (p = 0.57). There also was no statistical significance between groups in terms of arm volume when compared with measurements at baseline and 18 months (p = 0.54).
There appears to be a positive correlation between the RESTORE program and physical function in individuals immediately after breast cancer treatment. Unexpectedly, this did not translate into a decrease in lymphedema-related symptoms (like edema) or social perceptions of the disease.
Nurses should be aware of the symptoms that patients can present with after breast cancer remission. Nurses should encourage their patients to seek regular visits to their healthcare providers because this study showed that physical function can improve with more vigorous self-maintenance and early intervention. Further research should be conducted to determine the effectiveness of the RESTORE program as a standalone therapy.
Anderson, R., Jatoi, A., Robert, C., Wood, L.S., Keating, K.N., & Lacouture, M.E. (2009). Search for evidence-based approaches for the prevention and palliation of hand-foot skin reaction (HFSR) caused by the multikinase inhibitors (MKIs). Oncologist, 14, 291–302.
To systematically review the literature on the prevention and palliation of multikinase inhibitor (MKI)-associated hand-foot syndrome (HFS) to identify areas for further clinical study and to provide a foundation for evidence-based guidelines for HFS management
DATABASES USED: PubMed, Cochrane Database of Systematic Reviews, BIOSIS, and CANCERLIT
KEYWORDS: Hand foot syndrome, hand foot skin reaction, acral erythema, palmar-plantar erythrodysesthesia, acral erythrodysesthesia, Burgdorf reaction, toxic erythema of the palms and soles. Medical subject headings (MeSH) included skin disease, hand injuries, chemically induced, antineoplastic agents, and protein kinase inhibitors. Names of specific agents also were entered into the MeSH search.
INCLUSION CRITERIA: English language clinical studies; meta-analysis, reviews, or practice guidelines; literature through August 31, 2008. Literature was categorized (C) according to the type of agent and cutaneous reaction.
EXCLUSION CRITERIA: Conditions other than HFS, topics unrelated to antineoplastic therapy
TOTAL REFERENCES RETRIEVED = 2,069 abstracts
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: After screening for inclusion, 350 abstracts (17%) met criteria for inclusion in C1–C4 categories.
Prevention approaches for MKI-associated HFS included
The following are recommendations on patient education prior to MKI therapy.
Treatment and palliation for management of HFS symptoms:
Authors stated that no evidenced-based treatment algorithms exist for cutaneous toxicities of the MKIs in the dermatologic or oncologic literature. It was noted that none of these recommendations were based upon strong evidence-based data and that none of the C1 articles were randomized, controlled trials designed to test HFS reactions management. It was revealed that clinical approaches to HFS are largely anecdotal, from case reports, based on practices during clinical trials of antineoplastic treatment, obtained from post-marketing practices, or extrapolated from approaches often used with chemotherapeutic treatments.
No actual convincing evidence was found in this review for any recommendation identified.
This review points to the need for research to test and compare various recommendations for prevention and management of HFS on clinical and patient-centered outcomes.
Research is needed in the following.