Daniele, B., Perrone, F., Gallo, C., Pignata, S., De Martino, S., De Vivo, R., … D'Agostino, L. (2001). Oral glutamine in the prevention of fluorouracil induced intestinal toxicity: A double blind, placebo controlled, randomised trial. Gut, 48(1), 28–33.
To evaluate the effect of glutamine on intestinal absorption and permeability in patients with colorectal cancer
Patients receiving their first cycle of chemotherapy with 5-fluorouracil (5-FU) and folinic acid (FA) for five days were randomly assigned to receive either 18 g glutamine or placebo for 15 consecutive days, beginning 5 days before chemotherapy initiation. The experimental dose (18 g) was much greater than the normal dietary intake (1 g).
This study reported on 70 patients with colorectal cancer who were chemotherapy naïve.
This was a randomized, double blind, placebo-controlled, two armed, parallel trial.
Intestinal absorption (IA) was measured using d-xylose absorption test and intestinal permeability (IP) using cellobiose-mannitol permeability test. Both of these tests have been confirmed to be reliable and sensitive in clinical conditions characterized by disruption of the normal small intestinal mucosa (e.g., celiac disease, Crohn’s disease).
Glutamine was shown to reduce changes in IA and IP during 5-FU chemotherapy and may have a protective effect against diarrhea by enhancing the barrier function of the intestine.
This study used sensitive and reliable tests to evaluate the morphological changes to the intestine that are casually related to diarrhea incidence. The results are consistent with previous studies that have demonstrated the protective effects of glutamine on the intestinal mucosa.
Danhauer, S. C., Tooze, J. A., Holder, P., Miller, C., & Jesse, M. T. (2008). Healing touch as a supportive intervention for adult acute leukemia patients: a pilot investigation of effects on distress and symptoms. Journal of the Society for Integrative Oncology, 6, 89–97.
To determine the feasibility of conducting a randomized, clinical trial testing the effectiveness of healing touch (HT) for patients undergoing induction for acute leukemia and to obtain preliminary data to determine the effect size.
A prospective cohort of patients was selected to participate in the intervention trial. They completed self-report questionnaires and rated fatigue, nausea, pain, and distress at baseline, within seven days of hospital admission. Follow-up data collection was performed during the fifth week of hospitalization or prior to discharge. The HT intervention consisted of nine 30-minute sessions during weeks 2, 3, and 4. Family members were allowed to stay or leave during the session, depending on patient preference. All who provided the sessions were certified and had at least two years of experience with HT. All sessions were provided to the patient by the same practitioner. Sessions were standardized and included (1) the practitioner setting an intention for the patients’ highest good and (2) a standardized sequence of hand positions progressing from the ankles upward to the top of the head, with the hands placed either touching the patient or several inches above the body for one minute.
Patients were undergoing the active treatment phase of care.
The study was a prospective trial.
Of the individuals approached for study participation, 48% declined (66% due to lack of interest and 34% due to medical issues or feeling too ill). Three patients who initially entered withdrew, one due to family request and concerns about interference with medical treatment, one due to medical complications, and one after speaking with his minister who had religious objections to participation.
There were no significant changes from baseline to the five-week follow-up measurement on the MDASI, sleep quality measures, or POMS.
There were significant improvements on the patient self-report scale for fatigue (–1.8 change; p < 0.01) and nausea (–0.5 change; p < 0.01). Changes in distress were not significant. There were no changes in pain, and baseline values for pain were low (median = 1), although patient feedback suggested short-term pain reduction and improved sleep.
Of the patients, 91% liked HT “very much,” and most stated they felt more calm and relaxed during and after the sessions. All said they would recommend HT to others, and eight patients (73%) wanted to continue using HT.
Patients suggested improvements of providing a better explanation of HT, offering longer and more frequent sessions, and offering 30 minutes of protected quiet time for patients in addition to HT sessions.
The study demonstrated that use of HT in the acute setting is feasible and may benefit patients.
The study findings suggest that a simple intervention of providing protected, uninterrupted quiet time to patients can be helpful to patients. This is something that could be readily incorporated into nursing care. Findings suggest that further research in this area is feasible in acutely ill patients. Findings suggest that provision of quiet time control in further research would be a viable approach, as well as comparison to other strategies to elicit a relaxation response. Information regarding drop-out reasons suggest that more extensive explanation of HT and mechanisms of effects is warranted with use of HT.
Damstra, R.J., Voesten, H.G., van Schelven, W.D., & van der Lei, B. (2009). Lymphatic venous anastomosis (LVA) for treatment of secondary arm lymphedema. A prospective study of 11 LVA procedures in 10 patients with breast cancer related lymphedema and a critical review of the literature. Breast Cancer Research and Treatment, 113(2), 199–206.
To evaluate the effectiveness of lymphatic venous anastomosis (LVA) in the treatment of one-sided, breast cancer-related lymphedema
Unilateral lymphoscintigraphy was done with attention to liver uptake, and methylene blue was used to outline the lymphatic system. An experienced microvascular surgeon did the LVA procedures doing end-to-side anastomoses with micro instruments. Antibitoitics were used preoperatively, and the extremity was bandaged and elevated at night. Patients were followed at three months, six months, one year, and beyond. The mean final follow up was eight years.
The study took place at a single site in the Netherlands.
The study used a prospective descriptive design.
After six months, 5 of 10 patients had subjective relief according to SF-36 results. After one year, the mean volume difference between limbs was 1,075 cc, with a range of 500-1856, and the circumferential measurement demonstrated improvement of 4.8%. An initial postoperative volume reduction seen at 16% was lost in one year, at which time no more than a 2% difference between limbs was observed.
No significant improvements were found over the long term after an initial period of symptom relief and volume reduction.
The small prospective study suggests there is no long-term benefit of LVA surgery for management of lymphedema associated with breast cancer.
Damstra, R.J., & Partsch, H. (2009). Compression therapy in breast cancer-related lymphedema: A randomized, controlled comparative study of relation between volume and interface pressure changes. Journal of Vascular Surgery: Official Publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter, 49(5), 1256–1263.
To determine whether there is a difference between low- and high-pressure bandaging in intended volume reduction
Bilateral arm volume was measured before, two hours post-bandage placement, and after 24 hours. The amount of edema was calculated. Sub-bandage pressure was measured after bandage application and two hours later. Bandages were re-applied and pressure measurements were repeated. After 24 hours, pressure measurement was recorded and bandages were removed for final volumetry. Primary outcome measures were reduction of arm volume and edema in both study groups. Secondary outcomes were changes in sub-bandage pressure and patient comfort later. Patients were randomized into two groups: group A received low pressure bandages (20–30 mm Hg) and group B received high pressure bandages (44–58 mm Hg).
The study took place at Nij Smellinghe Hospital in Drachten, Netherlands.
The study used a randomized, controlled comparative design.
Median arm volume reduction after two and 24 hours was 104.5 ml (95% confidence interval [CI], 51.2–184.2) (–2.5%) (p < 0.0001) and 217 ml (95% CI, 143.9–280.2) (–5.2%) (p < 0.01) for group A and 56.5 ml (95% CI, 2.7–123.1) (not significant) and 167.5 ml (95% CI, 105.2–316.1) (–4.2%) (p < 0.01) for group B, respectively. There was no statistically significant difference between the volume changes in group A and group B. Bandages in group A were better tolerated. The sub-bandage pressure drop in the first two hours was between 41% and 48% in both treatment groups at both measuring sites. After 24 hours, the pressure drop was between 55% and 63%. No proximal swelling above the bandage was observed.
Inelastic, multi-layer, multi-component compression bandages with lower pressure (20–30 mm Hg) were better tolerated and achieved the same amount of arm volume reduction as bandages applied with higher pressure (44–58mm Hg) in the first 24 hours.
The sample size was small (N < 100).
More studies are needed to evaluate efficacy of lower pressure to better understand optimal treatment and tolerability, which will impact compliance.
Damstra, R.J., Brouwer, E.R., & Partsch, H. (2008). Controlled, comparative study of relation between volume changes and interface pressure under short-stretch bandages in leg lymphedema patients. Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [Et Al.], 34(6), 773–779.
To demonstrate that therapeutically intended volume reduction of the compressed leg is the most important cause for the loss of bandage pressure
All patients and control group volunteers were treated with the same bandages by trained staff. The bandages started at the base of the toes and covered the leg up to the capitulum fibulae in all cases. The bandages were removed after two hours, and new bandages were applied for the next 24 hours. On the first day, all patients were encouraged to walk and treated exclusively with compression therapy of the whole leg. No other therapeutic interventions were performed.
The study used an experimental, controlled comparative design.
A significant reduction of leg volume was achieved two hours after bandage application in both groups. A further volume decrease of the lymphedematous legs was observed in the following 24 hours after application of a new bandage. The volume reduction was associated with a significant loss of bandage pressure.
Volume reduction is the most important cause of loss of pressure and effectiveness, supporting the need for proper materials, technique, and compliance.
More frequent bandage changes, in the initial phase of edema reduction in patients with venous diseases, with compression treatment using short-stretch bandages appears to be necessary.
Damian, S., Celio, L., De Benedictis, E., Mariani, P., Agustoni, F., Ricchini, F., & De Braud, F. (2013). Is a dexamethasone-sparing strategy capable of preventing acute and delayed emesis caused by combined doxorubicin and paclitaxel for breast cancer? Analysis of a phase II trial. Oncology, 84(6), 371–377.
To evaluate the effectiveness of palonosetron without delayed dexamethasone in breast cancer patients receiving doxorubicin and paclitaxel (AT) for three cycles
Phase II, nonrandomized, single-arm feasible study
The Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 was given as a card to patients in order to grade the severity of nausea experienced. Patients also were asked to record emetic episodes and any antiemetic use.
74% of the patients achieved CC in the first cycle, but there was a small reduction in CC as treatment continued to subsequent cycles. Authors even mentioned that delayed dexamethasone can be added in to the regimen if more optimal CINV control is needed. It is challenging to see the relevance of the proposed regimen if delayed dexamethasone would still be needed and steroids are still a part of the premeds, even if delayed dexamethasone is not required.
Data have shown that dexamethasone can be decreased to day 1 only in combination with palonosetron with comparable nausea control. Data also have shown that CINV control with dexamethasone/palonosetron is superior than palonosetron as a single agent. Further investigation is required to determine if dexamethasone can be successfully replaced by other steroids in a premedication regimen.
Damholdt, M.F., Mehlsen, M., O'Toole, M.S., Andreasen, R. ., Pedersen, A.D., & Zachariae, R. (2016). Web-based cognitive training for breast cancer survivors with cognitive complaints—A randomized controlled trial. Psycho-Oncology, 25, 1293–1300.
To investigate the use of a web-based cognitive training intervention for subjective and objective cognitive complaints in breast cancer survivors
HAPPYneuron Pro© (Scientific Brain Training, Villeurbanne Cedex, France) is a customized 12-task training program of 6 cognitive domains (attention, processing speed, learning, memory, working memory, problem solving) involving 10 levels of difficulty. The program required a minimum commitment of 30 minutes a day for 5 days a week for 6 weeks.
PHASE OF CARE: Late effects and survivorship
Randomized, waitlist controlled, pretest–post-test design
Web-based cognitive training did not improve function for the PASAT-measured domain of working memory or the CFQ-measured secondary outcome of perceived cognitive function. Improvement was demonstrated for cognitive function on two other neuropsychologic measures for verbal learning (RAVLT) (F [2, 272.1] = 3.2, p = 0.043) and working memory (digit span backward) (F [2, 272.6] = 3.3, p = 0.04).
Primary and secondary outcomes were not achieved, but web-based cognitive training was associated with improvement onone test of verbal learning and one test of working memory. Further study with instruments validated for phone administration may be warranted.
The web-based cognitive training intervention was well received by participants and not burdensome to administer in terms of costs. Small improvements were noted for some cognitive measures in the intervention group, and further study may be warranted.
Dalton, J. A., Keefe, F. J., Carlson, J. & Youngblood, R. (2004). Tailoring cognitive-behavioral treatment for cancer pain. Pain Management Nursing, 5, 3–18.
To determine whether a profile-tailored cognitive-behavioral therapy (CBT) treatment program was more effective than either standard CBT or usual care in changing outcomes for patients with cancer-related pain.
Patients received standard CBT, profile-tailored CBT, or usual care. Therapy group sessions ranged from 5 to 50 minutes.
Standard CBT is comprehensive CBT that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship among pain, suffering, and emotions; to use symptom-coping skills, problem solving, relaxation, and self control; and to modify cognitive distortions associated with emotional distress.
Profile-tailored CBT matches patients’ scores on the Biobehavioral Pain Profile (BPP) to specific CBT modules, environmental influences, loss of control, healthcare avoidance, past and current experience, physiologic responsivity, and thoughts of disease progression.
RNs received a two-day training course to deliver the intervention.
The study was conducted at one inpatient and three outpatient cancer centers in the southeastern United States.
Patients were undergoing the active treatment phase of care.
This was a randomized, controlled trial.
Short-term outcome: Based on the BPI, interference with sleep improved from baseline to immediately postintervention for the profile-tailored CBT group.
Between-group comparison of the treatment effect over the entire study found treatment effects for interference of pain with mood and sleep. Response to the intervention decreased with time.
Dalton, J. A., Keefe, F. J., Carlson, J., & Youngblood, R. (2004). Tailoring cognitive-behavioral treatment for cancer pain. Pain Management Nursing, 5, 3–18.
Participants received standard cognitive-based therapy, profile-tailored cognitive-based therapy, or usual care. Those in both therapy groups received 5- to 50-minute sessions. Standard cognitive-based therapy includes comprehensive cognitive and behavioral therapy that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship between pain, suffering, and emotions; to use symptom coping skills, problem-solving, relaxation, and self control; and to modify cognitive distortions associated with emotional distress. Profile-tailored cognitive-behavioral therapy (CBT) matched patient scores on the Biobehavioral Pain Profile (BPP) to specific CBT modules: environmental influences, loss of control, health care avoidance, past and current experience, physiological responsitivity, and thoughts of disease progression.
One inpatient and three outpatient cancer centers in the Southeastern United States
Participants were undergoing the active treatment phase of care.
The study was a randomized trial.
Profile of Mood States (POMS) Symptom Distress Scale
No significant effects on fatigue were found.
Dahlen, T., Kalin, M., Cederlund, K., Nordlander, A., Bjorkholm, M., Ljungman, P., & Blennow, O. (2016). Decreased invasive fungal disease but no impact on overall survival by posaconazole compared to fluconazole prophylaxis: A retrospective cohort study in patients receiving induction therapy for acute myeloid leukaemia/myelodysplastic syndromes. European Journal of Haematology, 96, 175–180.
To investigate the effects of changing from floconazole to posaconazole on the incidence of invasive fungal disease (IFD) and survival
Data were obtained from medical records for analysis. From 2008 to March 2011, primary antifungal prophylaxis was fluconazole 100–200 mg daily. In 2011, prophylaxis was changed to posaconazole 200 mg three times per day. Fungal prophylaxis in most cases was done only during neutropenia. Wards were not equipped with HEPA filters. Bacterial prophylaxis with ciprofloxacin was used during neutropenia in 80%–90% of patients. In 283 patients, comparison of results with posaconazole versus fluconazole was done.
PHASE OF CARE: Active antitumor treatment
Retrospective cohort comparison
IFD was defined according to the revised 2008 European Organization for Research and Treatment of Cancer (EORTC) definitions.
The incidence of IFD was signficantly lower at day 100 and at the end of patient follow-up (p < 0.01). The incidence of aspergillosis (p = 0.01) and invasive candidiasis (p < 0.05) were also lower in those given posaconazole. Antifungal therapy was more common in the fluconazole group (p < 0.01). There was no difference in overall survival at day 100 or at the end of follow-up.
The use of posaconazole for primary antifungal prophylaxis was more effective for reduction in IFD compared to fluconazole.
Posaconazole was shown to be more effective than fluconazole for the prevention of IFD in high-risk patients; however, the retrospective nature and other design factors limit the validity of this study. A variety of research is aimed at the determination of the most effective antifungal agents for prophlyaxis. Additional research is needed to determine if specific antifungals are more effective overall.