Demers, M., Dagnault, A., & Desjardins, J. (2013). A randomized double-blind controlled trial: Impact of probiotics on diarrhea in patients treated with pelvic radiation. Clinical Nutrition (Edinburgh, Scotland), 33(5), 761–767.
To determine the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea in patients with pelvic cancer undergoing therapy, with a secondary objective to assess whether Bifilact® decreased or delayed the need for antidiarrheal medication, reduced intestinal pain, decreased hospitalization, lowered the interruption of radiotherapy treatments or doses of both radiotherapy and chemotherapy, and improved the overall well-being of patients during treatment
Patients were divided into three groups: prostatic cancers, gynecologic cancers without chemotherapy, and gynecologic or rectal cancers with chemotherapy. Then, using double-blind procedures, patients were block-randomized by blocks of two, four, or six patients according to random permutations. A second random block using a higher probiotic dosage was added after an interim analysis. New, random lists were generated for each stratum with a 3:1:1 ratio (higher dose, standard dose, placebo). Nutritional intervention was enacted with a diet teaching to control dietary lipids and providing recommendations on fiber and carbohydrate intake. Yogurt consumption was encouraged.
Prospective, single-center, placebo-controlled, randomized, double-blinded trial
229 patients were analyzed. For the primary endpoint among all groups, there was no difference in the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea. At the 60-day point, there were more patients without moderate and severe diarrhea in the standard-dose group (35%) compared with the placebo group (17%) (hazard ratio of 0.69, p = 0.04). The postsurgical group with patients taking the standard dose had fewer patients without very severe diarrhea compared to the placebo group (97% and 74%, respectively) (p = 0.03). While undergoing therapy, the average number of bowel movements per day during treatment was less than three soft stools (p = 0.80), and the median level of abdominal pain was < 1 based on the NCI scale (p = 0.23).
Bifilact®, when administered in standard doses to patients with pelvic cancer undergoing therapy, may reduce the risk of radiation-induced grades 2–4 diarrhea towards the end of the treatment. While receiving radiation therapy, a standard dose of probiotics may reduce radiation-induced grade 4 diarrhea in patients who had prior surgery.
Nurses may want to consider offering counseling and education regarding probiotics as a potential alternative approach to reducing radiation-induced diarrhea.
De Marinis, F., Eberhardt, W., Harper, P.G., Sureda, B.M., Nackaerts, K., Soerensen, J.B., . . . Tredaniel, J. (2009). Bisphosphonate use in patients with lung cancer and bone metastases: Recommendations of a European expert panel. Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer, 4(10), 1280–1288.
To review current evidence regarding the use of bisphosphonates for the treatment of lung cancer and to provide European recommendations for practice
An expert panel of European clinical oncologists and lung cancer specialists reviewed available evidence regarding the use of bisphosphonates for the treatment of lung cancer and developed recommendations based on the evidence and clinical experience. The International Association for the Study of Lung Cancer published the resulting report. Authors did not provide specific search description, cite the process of review, or present evidence.
The report made the recommendations that follow.
The International Association for the Study of Lung Cancer recommends the use of bisphosphonates in general and zoledronic acid in particular for patients, with all types of lung cancer, who have bone metastases. Nurses should be aware of potential adverse events of this treatment, though it is generally well tolerated. Because bisphosphonate treatment is associated with osteonecrosis, patients should have a comprehensive dental examination and prophylaxis before starting bisphosphonate treatment. Nurses should also be aware of the potential renal effects of bisphosphonate, especially on patients whose renal function has deteriorated as the result of other nephrotoxic drugs, dehydration, renal impairment, or lack of adherence to the recommended infusion schedule for bisphosphonate.
Delia, P., Sansotta, G., Donato, V., Frosina, P., Messina, G., De Renzis, C., & Famularo, G. (2007). Use of probiotics for prevention of radiation-induced diarrhea. World Journal of Gastroenterology, 13(6), 912–915.
To examine the effect of probiotic use for prevention of radiation-induced diarrhea
The experimental group received high-potency probiotics (VSL#3 in one sachet) three times per day beginning on the first day of radiation therapy until the end of scheduled cycles. The VSL #3 sachet contained 450 billions/gm of viable lyophilized bacteria, including 4 strains of lactobacilli (Lactobacilli casei, L. plantarum, L acidophilus, and L. delbruekii subsp. Bulgaricus); 3 strains of Bifidobacteria (B. longum, B. breve, and B. infantis) and 1 strain of Streptococcus salivarius subsp. thermophilus.
The control group received an identical-appearing placebo.
This study reported on 490 patients receiving adjuvant radiation therapy after surgery for sigmoid, rectal, or cervical cancer.
This was a double blind, randomized, placebo-controlled trial.
Efficacy endpoints included incidence and severity of radiation-induced diarrhea, the number of bowel movements (BMs) per day, and the time from start of study until need for loperamide.
Endpoints (clinical symptoms, use of medications, and any adverse events) were reviewed with patients weekly during scheduled radiation therapy treatments and again one month after completion.
Use of a probiotic lactic-acid producing bacteria is a safe, easy, feasible approach to preventing radiation-induced diarrhea after surgery for abdominal and pelvic cancer.
Probiotic lactic-acid-producing bacteria is safe for use in patients receiving radiation treatment, and it is not associated with bacteremia, sepsis, or septic shock. Lactobacilli lowers the production of proinflammatory cytokines and other effectors of inflammation and tissue injury. Probiotic bacteria upregulates the innate immune response in the gut and protects against invasive organisms. Further studies are needed on different probiotic preparations and mixtures.
Del Fabbro, E., Dev, R., Hui, D., Palmer, L., & Bruera, E. (2013). Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial. Journal of Clinical Oncology, 31, 1271–1276.
To compare melatonin with placebo for impact on appetite in patients with advanced cancer
Patients were randomly assigned to receive 20 mg melatonin or identical placebo daily for 28 days. Study assessments were done at baseline and at four weeks. Patients were stratified according to whether or not they were currently receiving antitumor treatment.
The study was a double-blind, randomized, placebo-controlled trial.
There were no significant differences between groups in symptoms or change in symptoms at four weeks. There were no differences in change in body weight or body composition. Thirty-three percent of patients were lost to follow-up.
Melatonin had no effect on appetite or other symptoms in patients with advanced cancer.
Findings of this study do not support the use of melatonin to improve appetite or other symptoms in patients with advanced cancer.
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.