Del Giglio, A.B., Cubero Dde, I., Lerner, T.G., Guariento, R.T., de Azevedo, R.G., Paiva, H., . . . Giglio, A.D. (2013). Purified dry extract of Paullinia cupana (guarana) (PC-18) for chemotherapy-related fatigue in patients with solid tumors: An early discontinuation study. Journal of Dietary Supplements, 10, 325–334.
To evaluate the effect of dry extract guarana (PC-18) on cancer-related fatigue (CRF) in patients with solid tumors and to evaluate the effect of maintenance doses on CRF in patients who initially improve
PC-18 37.5 mg orally twice daily for 21 days. Those with improved or stable BFI scores were randomized to 37.5 mg BID dosing of PC-18 or placebo for an additional 21 days.
Mean BFI score decreased by 2.503 points (p = .0002). No significant difference was noted between PC-18 and placebo groups after randomization in BFI (p = .8499), Chalder (p = .6321), FACIT-F (p = .7452), HADS-A (p = .7521), HADS-D (p = .9425), or PSQI (p = .807). There was one instance of grade III depression and one instance of grade III dizziness experienced in PC-18 that was not experienced in placebo. Grade II dizziness and tremors (one instance of each) also reported in PC-18 group, but not in placebo group.
BFI improvement was seen in the induction phase with no significant difference once patients were randomized. It is difficult to make any positive conclusions on guarana as all patients initially had the drug with no washout period before randomization. Potential side effects of guarana may be undesirable.
The study is limited by its sample size and study design. Use of guarana for CRF is not supported by this study.
Del Fabbro, E., Garcia, J.M., Dev, R., Hui, D., Williams, J., Engineer, D., . . . Bruera, E. (2013). Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: A preliminary double-blind placebo-controlled trial. Supportive Care in Cancer, 21, 2599-2607.
Gluteal injections of testosterone or placebo were administered at baseline, day 15, day 29, day 43, and day 57. Outcome measures were determined on day 29.
PHASE OF CARE: Transition phase after active treatment
APPLICATIONS: Elder care and palliative care
Randomized, double-blinded placebo-controlled trial
There were no statistically significant differences in FACIT-fatigue subscale or total scores; in testosterone levels between placebo and testosterone groups; and in the secondary outcome of anorexia/cachexia and sexual desire at day 29. ECOG-PS scores improved in the testosterone group, but the differences were not significant.
Testosterone replacements in hypogonadal male patients with advanced cancer did not significantly improve quality of life.
This study did not demonstrate any benefit of testosterone replacement in this group of patients.
De Jong, F.A., Kehrer, D.F., Mathijssen, R.H., Creemers, G.J., de Bruijn, P., van Schaik, R.H., … De Jong, M.J. (2006). Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: A double-blind, randomized, placebo-controlled study. Oncologist, 11, 944–954.
Patients were treated with 350 mg/m2 irinotecan during their first cycle of chemotherapy combined with 660 mg neomycin (n = 28; 45%) administered three times daily for three consecutive days starting two days before irinotecan or combined with placebo (n = 34; 55%).
The two groups were balanced for demographic parameters, hematologic function, bilirubin, and liver enzyme values. The administered dose of irinotecan did not differ significantly between groups (mean dose of 640 mg versus 679 mg, p = 0.9).
This was a double-blind, randomized, placebo-controlled study.
Degnim, A.C., Hoskin, T.L., Brahmbhatt, R.D., Warren-Peled, A., Loprinzi, M., Pavey, E.S., . . . Esserman, L.J. (2014). Randomized trial of drain antisepsis after mastectomy and immediate prosthetic breast reconstruction. Annals of Surgical Oncology, 21, 3240–3248.
To evaluate the effects of antiseptic drain care on drain colonization and infection after immediate breast reconstruction
Patients undergoing bilateral mastectomy and immediate breast reconstruction had right and left breast area randomly assigned to usual drain care or the experimental protocol. All subjects received IV antibiotics within 30 minutes of surgical incision and oral antibiotics until drains were removed. All participants and family members were instructed in drain care. The experimental procedure involved application of a chlorhexidine disc to drain sites every three days and irrigation of the drainage bulb with dilute Dakins solution (0.0125% sodium hypochlorite) twice daily. Patients were followed at post-op day (POD) 6–10 for culture of drain fluid. Drains were removed as individually appropriate, and tubing and fluid were cultured at that time. Surgical site infections were identified within 365 days of surgery.
Drain bulb fluid colonization POD 6–10 was 9.9% with antisepsis and 20.8% with control management (p = 0.02). Drain tubing and bulb fluid colonization at removal was significantly higher in the control condition (p ≤ 0.03). At POD 30, SSI rate was 3.8% among controls and 0% with the antisepsis protocol, and at one year, SSI rate was also lower in the antisepsis group. SSI rates were not significantly different.
Drain antisepsis with chlorhexidine patch and irrigation with dilute Dakin’s solution was associated with reduced drain and drain fluid colonization, but did not produce significant differences in surgical-site infections.
The procedure tested here for drain antisepsis produced less drain colonization but did not demonstrate longer term significant results to reduce surgical site infection, though infection rates were lower with the antisepsis. Further research is warranted to confirm any significant difference. Though SSI rates tend to be rather small, SSI post bilateral mastectomy and breast reconstruction can be devastating. Drain antisepsis approaches may provide an opportunity to reduce risk of postoperative surgical-site infections in which drains are used.
Deer, T.R., Smith, H.S., Burton, A.W., Pope, J.E., Doleys, D.M., Levy, R.M., … Center For Pain Relief, Inc. (2011). Comprehensive consensus based guidelines on intrathecal drug delivery systems in the treatment of pain caused by cancer pain. Pain Physician, 14(3), E283–E312.
To identify guidelines for implementing intrathecal therapy (IT) and provide considerations for effective analgesia for chronic pain in patients with cancer or others at the end of life
This resource provides a summary of evidence and relevant recommendations regarding patient selection for IT therapy, implications of prior therapy and its results, use of IT pain therapy with concurrent chemotherapy or radiation, implications with epidural metastases, infection, comorbid conditions, social issues, and healthcare coverage.
Recommendations provided are limited by reliance on consensus and the limited evidence available from clinical trials regarding the application of IT.
Consideration for comorbidities, support systems, compliance with recommended treatment plan, current or prior therapies, incorporation of the oncologist into the treatment plan, psychological monitoring, and appropriate trialing technique are key in the use of IT therapy. The authors advocate for wider application of IT therapy to effectively manage patients experiencing cancer and end-of-life pain.
De Conno, F., Ripamonti, C., Fagnoni, E., Brunelli, C., Luzzani, M., Maltoni, M., . . . MERITO Study Group. (2008). The MERITO Study: A multicentre trial of the analgesic effect and tolerability of normal-release oral morphine during 'titration phase' in patients with cancer pain. Palliative Medicine, 22(3), 214–221.
To assess the effect and tolerability of oral normal-release morphine (NRM) during the initial phase of the treatment of patients with moderate to severe cancer pain
Eligible patients received oral NRM at a starting dose of 5 or 10 mg every four hours. Patients whose pain was not controlled with World Health Organization (WHO) step I analgesics received 5 mg NRM. Patients who received step II therapy received 10 mg NRM. Patients who did not get satisfactory pain relief during the interval between one dose and the next could take rescue doses of oral NRM, up to one dose every hour; rescue NRM doses were the same as the patient’s regular doses. Dose was retitrated on a daily basis so that the dose of oral NRM to be given in the next 24 hours was based on the total opioid dose (regular plus rescue). If possible, patients completed an ambulatory visit for assessment after two and five days from the beginning of the study. On other days, patients received a telephone call that monitored pain intensity, drug dose, and onset of symptoms.
Open-label, phase IV clinical trial
Oral NRM, administered according to European Association for Palliative Care recommendations, can effectively and rapidly decrease pain intensity. In opioid-naive patients, oral NRM has an acceptable safety profile.
This trial demonstrated that clinicians should begin administering NRM as soon as possible to treatment moderate to severe cancer-related pain instead of waiting until the patient is at an advanced or terminal stage. Through titration, the analgesic treatment was tailored to the patient’s needs, and close evaluation and re-evaluation of pain intensity and frequency helped ensure that the therapy continued to be effective and tolerated. Nurses can advocate for NRM when caring for patients with higher levels of pain, thereby increasing the patient’s level of comfort and optimizing patient-centered treatment.
Decker, T. W., Cline-Elsen, J., & Gallagher, M. (1992). Relaxation therapy as an adjunct in radiation oncology. Journal of Clinical Psychology, 48, 388–393.
Patients were instructed in six individual one-hour sessions on the use of progressive muscle relaxation (PMR) and were provided with a relaxation tape and written instructions. In addition to relaxation training, the session provided support focused on concerns related to cancer radiation treatment and its effects and on the physical and emotional sensations experienced. During the fourth session, cue-controlled relaxation was presented as an active coping process that included four steps: PMR, deep breathing, pairing the relaxed state with a self-induced cue word (“calm\"), and coping with tension by self-administration of the cue-controlled relaxation response. During the last session, client concerns about cancer, treatments, stress, and relaxation were reviewed, and further questions were answered. The importance of practicing relaxation regularly at home was emphasized. The control group received usual care.
Outpatient radiation treatment facility
Patients were undergoing the active treatment phase of care.
The study was a randomized, controlled trial with a usual care control group.
Profile of Mood States (POMS)
Patients receiving relaxation training reported a significant reduction in tension and anger and a trend toward less depression. Comparisons between the relaxation therapy and control groups using MANOVA indicated that there were no statistically significant differences in the pre- and posttest scores for the controls, with the exception of fatigue; patients in the control group became significantly more fatigued (p = 0.01).
Deauna-Limayo, D., Aljitawi, O.S., Ganguly, S., Abhyankar, S., Wick, J.A., & McGuirk, J.P. (2014). Combined use of multiday palonosetron with aprepitant and low-dose dexamethasone in prevention of nausea and emesis among patients with multiple myeloma and lymphoma undergoing autologous hematopoietic stem cell transplant: A pilot study. Journal of Oncology Pharmacy Practice, 20, 263–269.
To assess emetic responses to multiday palonosetron, aprepitant, and low-dose dexamethasone among patients treated with pretransplant regimens for multiple myeloma and lymphoma prior to undergoing stem cell transplantation
Oral aprepitant with IV dexamethasone and palonosetron was administered on days -3, -2, -1 for multiple myeloma and days -7 through -5 for patients with lymphoma. The patients with lymphoma also received IV dexamethasone and palonosetron on days -4 and -3. Palonosetron was repeated on third post transplant day. Patients with multiple myeloma were given melphalan, and patients with lymphoma received BCNU, etoposide, cytarabine, and melphalan with or without rituximab. Patients with multiple myeloma completed questionnaires on days -2, -1, +3, and +7. Patients with lymphoma completed questionnaires on days -6 through -2 and on days +3 and +7. The Common Terminology Criteria for Adverse Events version 3 wascused to evaluate nonhematologic toxicities.
Nonrandomized, prospective, descriptive cohort design
Complete control (CC) was achieved in the acute phase by 55% of patients with multiple myeloma and 100% of patients with lymphoma for a combined acute phase CC of 78%. In the delayed phase, CC fell to 22% in the multiple myeloma group and 44% in the lymphoma group. In the extended phase, CC fell to 11% and 22%, respectively. No complete emetic response was noted in either group, and no patients experienced more than five emetic episodes with a 24-hour period. They reported no significant nausea in the acute phase although they could not report on nausea in the delayed and extended phases because of missing data. Overall nausea remained a major problem with 78% of all patients developing some level of nausea.
Nausea and vomiting continued to be problematic for both groups in the post-transplant period, and these data were correlated with worsening Osoba scores. This drug combination was safe, feasible, and effective in the acute phase of CINV. However, other strategies are needed to treat patients scheduled for stem cell transplants.
The results of this study were not strong enough to influence treatment protocols. However, the study did underscore the need to assess patients receiving stem cell transplantations for at least a week for CINV.
de Valois, B. A., Young, T. E., Robinson, N., McCourt, C., & Maher, E. J. (2010). Using traditional acupuncture for breast cancer-related hot flashes and night sweats. Journal of Alternative and Complementary Medicine, 16, 1047–1057.
To determine if traditional acupuncture (TA) could reduce hot flashes and night sweats (HF&NS) frequency, improve physical and emotional well-being, and improve perceptions of HF&NS in women receiving tamoxifen after active breast cancer treatment.
Women with a diagnosis of breast cancer receiving tamoxifen who reported experiencing HF&NS for more than three months underwent eight sessions of TA, delivered once weekly. They were monitored for 30 weeks, during which there were five measurement points. Data were collected using a paper-based hot flash diary. Physical and emotional well-being were measured using two questionnaires: the Women’s Health Questionnaire (WHQ) and the Hot Flashes and Night Sweats Questionnaire (HFNSQ).
This was a prospective, single-arm, observational study using before and after measurements.
HF&NS mean frequency was reduced by 49.8% (95% confidence interval [40.5, 56.5]; p < 0.0001; n = 48) at end of treatment (EOT) over baseline. Trends indicated longer-term effects of TA at 4 and 18 weeks after EOT. At EOT, seven WHQ domains showed significant statistical and clinical improvements, including Anxiety/Fears, Memory/Concentration, Menstrual Problems, Sexual Behavior, Sleep Problems, Somatic Symptoms, and Vasomotor Symptoms. Perceptions of HF&NS as a problem were reduced by 2.2 points (standard deviation = 2.15 points; n = 48; t = 7.16; p < 0.0001).
The study supports using TA to manage HF&NS in women receiving tamoxifen as a breast cancer treatment. In addition, it suggests that the women received the added benefit of improved emotional and physical well-being with few side effects.
Nurses should recognize that tamoxifen continues to pose distressing side effects in women with breast cancer, even after prolonged use. This study suggests that, through the use of TA, women receiving tamoxifen may be able to control some of these distressing side effects. Randomized, controlled trials using larger samples are warranted to validate TA as a tool for reducing these common side effects. Future studies, if including concomitant medications for hot flash symptoms, may want to control the types of concomitant medication usage for further analysis of results or have a randomized group to TA alone to TA plus a specific concomitant medication to note if hot flash symptoms are further controlled.
de Rezende, L.F., Franco, R.L., de Rezende, M.F., Beletti, P.O., Morais, S.S., & Gurgel, M.S. (2006). Two exercise schemes in postoperative breast cancer: Comparison of effects on shoulder movement and lymphatic disturbance. Tumori, 92(1), 55–61.
The study compared the effects on shoulder movement and lymphatic disturbance of two exercise schemes after surgery in patients with breast cancer. Subjects were randomly assigned to two exercise groups based on kinesiotherapy: directed group guided by a physiotherapist with a regimen of 19 exercises (exercises were performed 10 times with 60-second intervals between exercises) and free group, which had no defined sequence or number of repetitions. Both groups began with three exercises beginning on the first day after surgery. Exercises were performed in outpatient physiotherapy department. The study was reviewed by the Research Commission and Ethics Committee of the faculty of medical sciences. Patients participated in a 40-minute session three times weekly for a period of 42 days.
Patients were recruited from State University of Campinas, Brazil.
No difference in groups was found in terms of individual characteristics and clinical-surgical characteristics. Incidence of infection was similar in both groups. Lymphatic disturbance showed no statistical difference between groups. Incidence of seroma was not statistically different between groups. The directed exercise group had more recovery of range of motion in shoulder in flexion, abduction, and external rotation compared with the free group. Patients who received directed exercises achieved better function and return to premorbid function than those patients who did free exercise.