Poonawalla, I.B., Piller, L.B., Lairson, D.R., Chan, W., & Du, X.L. (2016). Impact of hematopoietic growth factors on blood transfusion needs, incidence of neutropenia, and overall survival among elderly advanced ovarian cancer patients treated with chemotherapy. International Journal of Gynecological Cancer, 26, 95–103.
To determine the effectives of an erythropoietin-stimulating agent (ESA) and granulocyte–colony-stimulating factor (G-CSF) in reducing blood transfusion needs and neutropenia incidence in community-dwelling older adults with ovarian cancer
Woman aged older than 65 years diagnosed with stage III–IV epithelial ovarian cancer (from January 2000–December 2009) were identified as having received chemotherapy by procedure codes in Medicare within nine months of diagnosis. Cox models were used for analysis and included time-dependent covariates. ESAs and G-CSFs were identified by Healthcare Common Procedure Coding System codes for epoetin-alfa/darbepoetin-alfa and filgrastim/pegfilgrastim. Blood transfusion need was measured from the time of diagnosis to first Medicare claim indicating the receipt of blood transfusion. Neutropenia incidence was measured from the time of the first chemotherapy administration to the first claim of neutropenia. Patients who did not receive a blood transfusion or did not develop neutropenia were censored at the date of death or last date in Medicare claims (i.e., December 31, 2010), whichever occurred first. Overall survival was measured from the time of first chemotherapy administration until death or the end of the follow-up period (December 31, 2011). Patients not experiencing the event (death) by this date were censored.
Retrospective cohort study using SEER Medicare linked database
ESAa were effective in reducing blood transfusion need. G-CSFs were effective in lowering neutropenia incidence and were associated with improved survival in older adults with ovarian cancer. The interaction between ESA time and CSF time was significant (p = 0.0001).
The findings demonstrated that using epoetin-alfa or darbepoetin-alfa effectively lowers the blood transfusion needs by 48%–78% in patients receiving chemotherapy, which is comparable to prior randomized trials of patients with gynecologic and ovarian cancer. The use of a G-CSF was associated with a longer survival compared to those who received at least three doses of a G-CSF. The findings showed that patients who received fewer than three prophylactic G-CSF administrations did not experience better outcomes.
This was a good study; however, it had a very focused patient population and may not be reproducible in the younger population. In addition, no information was provided regarding adverse events related to the use of ESAs or G-CSFs. Prior studies have shown a possible higher risk for mortality with the use of ESAs and G-CSFs. It is important to continue to look at established guidelines (Oncology Nursing Society, American Society for Clinical Oncology, National Comprehensive Cancer Network, Food and Drug Administration) for the use of ESAs and G-CSFs in the cancer population.
Pommier, P., Gomez, F., Sunyach, M.P., D’Hombres, A., Carrie, C., & Montbarbon, X. (2004). Phase III randomized trial of calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22(8), 1447–1453.
To assess effectiveness of calendula for prevention of acute radiation-induced dermatitis of grade 2 or higher during radiation therapy compared with trolamine
Patients were randomly allocated to application of trolamine or calendula on irradiated fields after each session. Patients started topical application of ointment at onset of radiation therapy, twice a day or more, depending on occurrence of dermatitis and pain, until completion. Patients were instructed not to use the agent two hours or less before an irradiation session or before treatment evaluation. No other prophylactic creams, lotions, or gels were allowed. Physicians were free to treat established dermatitis grade 2 or higher or allergy as considered appropriate. Clinicians were blinded to the treatment used
The study took place at Centre Leon Berard in Lyon, France.
The study used a randomized, blinded controlled trial design.
The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < .001) with use of calendula versus trolamine. Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin. Patients receiving calendula had less frequent interruption of radiation therapy. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in trolamine group, 12 due to skin toxicity. No allergic reactions were observed in the calendula group, whereas four patients in the trolamine group developed allergic-type reactions of pruritus and urticaria. Patients receiving calendula had significantly reduced radiation-induced pain. Mean maximal pain evaluated in calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03). Self-assessed satisfaction was greater with calendula. Prevention of erythema was 69% in the calendula arm versus 39% in the trolamine arm. Prevention of pain was 65% with calendula versus 46% with trolamine. Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of trolamine group. The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was 25 or higher (p < 0.001), who had received chemotherapy before radiation therapy after a lumpectomy (p = 0.01), and who were using trolamine (p < 0.001).
Calendula was shown to be effective in reducing skin toxicity of radiation compared to trolamine.
Because of differences in texture, color, and smell, it was not possible to perform a double-blind randomized study.
Pommier, P., Gomez, F., Sunyach, M. P., D’Hombres, A., Carrie, C., & Montbarbon, X. (2004). Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22, 1447–1453.
To assess the effectiveness of Calendula for the prevention of acute radiation (RT)-induced dermatitis of grade 2 or higher during RT compared with trolamine (Biafine).
The study was a randomized, blinded, controlled trial.
Pollak, J.S., Burdge, C.M., Rosenblatt, M., Houston, J.P., Hwu, W.J., & Murren, J. (2001). Treatment of malignant pleural effusions with tunneled long-term drainage catheters. Journal of Vascular and Interventional Radiology: JVIR, 12(2), 201-208.
The objective of the study was to assess the effectiveness of tunneled pleural catheters in the treatment of malignant pleural effusions.
Initial enrollment of the first one-third of patients (n = 9) involved 2:1 randomization to the newly available and not U.S. Food and Drug Administration (FDA)-licensed PleurX® catheter or chest tube-administered chemical pleurodesis with doxycycline. The remaining 19 patients after October 1997 all were treated with the PleurX® catheter.
The study had a prospective convenience sample, with randomization of the initial one-third of patients. The study for the remaining two-thirds of the patients had a nonrandomized prospective design.
This small, single-site, prospective study of the effectiveness of tunneled pleural catheters showed effective pleural drainage, spontaneous pleurodesis equivalent to chest catheter pleurodesis, reduced days of hospitalization (as the procedure can be safely performed outpatient), reduced distressing symptoms, and rare complications.
Its use in patients with refractory effusions could be advantageous, as it represents patients who have received other therapies prior to catheter insertion. The average life expectancy of patients with malignant pleural effusions is only 6–12 months, with as many as half of patients dying within 30 days. Patients with malignant pleural effusions represent a group who experience significant symptoms that affect quality of life. Interventions that are low-intensity, can be performed quickly and with limited recovery time, and can be managed in the ambulatory or home setting are optimal. Nurses can act as advocates for innovative management of malignant pleural effusions that enhance patient independence. Nurses are key patient and family educators who provide guidance, support, and hands-on instruction in management of tunneled pleural catheters. Their follow-up with patients and caregivers assist in the detection of complications, as well as evaluation of efficacy. Follow-up nursing assessment for symptom relief and spontaneous pleurodesis or the need for additional interventions may be especially important for these patients receiving end-of-life care with limited contact with physicians.
Pockaj, B.A., Gallagher, J.G., Loprinzi, C.L., Stella, P.J., Barton, D.L., Sloan, J.A., … Fauq, A.H. (2006). Phase III double-blind, randomized, placebo-controlled crossover trial of black cohosh in the management of hot flashes: NCCTG trial N01CC1. Journal of Clinical Oncology, 24, 2836–2841.
The purpose of the study was to measure the efficacy of black cohosh (one capsule, Cimicifuga racemosa 20 mg twice daily) for the treatment of hot flashes in women with and without a history of breast cancer.
Participants received four weeks of therapy with black cohosh or an identical appearing placebo. The black cohosh or placebo was given as one tablet twice per day. After completing the first four weeks, participants were crossed over to the alternative treatment arm.
This was a double-blind, randomized, cross-over clinical trial with two four-week periods.
Participants completed a prospective, daily hot flash diary during the baseline week and then during the two four-week crossover treatment periods. Hot flash scores were measured by assigning points to each hot flash based on severity (1 for mild to 4 for very severe) and then adding the points for a given time period.
The primary end point was the average intrapatient hot flash score (which is a construct of average daily hot flash severity and frequency) difference between the baseline week and the last study week of the first treatment period. Hot flash activity was analyzed in a number of ways. The difference between treatment week 4 (study week 5) and baseline hot flash score (study week 1) was compared between placebo and black cohosh arms by standard two-sided Wilcoxon procedures. Confidence intervals were constructed for median reductions in hot flash frequency and score. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (p = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (p = .36). Patient treatment preferences were measured after completion of both treatment periods. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Toxicity was minimal across both groups.
This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.
Limitations of the study included using a subset of participants did not have a diagnosis of breast cancer but met the eligibility criteria of a perceived increased risk of breast cancer, or did not want to take estrogen because of the increased risk of breast cancer. The numbers of participants with and without a breast cancer diagnosis were not specified.
Poage, E.G., Rodrick, J.R., Wanchai, A., Stewart, B.R., Cormier, J.N., & Armer, J.M. (2014). Exploring the usefulness of botanicals as an adjunctive treatment for lymphedema: A systematic search and review. PM&R, 7, 296–310.
PHASE OF CARE: Late effects and survivorship
One botanical intervention, alpha benzopyrones, had benefits that were balanced with harms, but the effectiveness of all other botanical interventions was not established. At this time, botanical supplements cannot be recommended as part of a therapeutic protocol to manage lymphedema in patients with cancer.
At this time, there is limited high-quality evidence investigating the potential use of botanicals in the treatment of cancer-related lymphedema. The number of studies using botanical interventions is small, and most possess significant design flaws. This review did not clearly state the inclusion and exclusion criteria used to select literature, and patient demographics were not described.
At this time, botanical supplements should not be considered as part of routine care in the treatment of cancer-related lymphedema. Nurses must be knowledgeable about the various botanical supplements patients may be using, and they must always assess patients for the use of any botanical supplements. Nurses should council patients who are taking or who ask about botanical supplements on the current state of the research.
Pitten, F.A., Kiefer, T., Buth, C., Doelken, G., & Kramer, A. (2003). Do cancer patients with chemotherapy-induced leukopenia benefit from an antiseptic chlorhexidine-based oral rinse? A double-blind, block-randomized, controlled study. Journal of Hospital Infection, 53(4), 283–291.
To assess the benefit of antiseptic mouthwash in patients with leukopenia because of a decrease in micro-organisms
Chlorhexidine did not provide a clinical benefit against mucositis.
Pitceathly, C., Maguire, P., Fletcher, I., Parle, M., Tomenson, B., & Creed, F. (2009). Can a brief psychological intervention prevent anxiety or depressive disorders in cancer patients? A randomised controlled trial. Annals of Oncology, 20, 928–934.
To determine if baseline intervention in persons free of depression and anxiety can prevent development of depression or anxiety at 6 and 12 months after diagnosis
Subjects were randomized to either the immediate-intervention or delayed-intervention groups. Intervention consisted of a 90-minute face-to-face interview followed by two telephone interviews (45 minutes each) at two weeks and six weeks after the initial interview. Therapeutic intervention included storytelling about initial experiences with diagnosis, exploration of thoughts about cancer-related events and concerns, and use of a booklet for examples of ineffective coping strategies.
Active treatment
Randomized controlled trial
The therapeutic psychological intervention demonstrated the potential to prevent disorders relating to depression and anxiety in cancer patients at high risk for development of depression.
In-person or by-telephone cognitive behavioral intervention delivered by nurses trained in intervention delivery could help to reduce the prevalence of depression and anxiety in newly diagnosed cancer patients. Initial determination of risk for development of clinical depression and anxiety can be useful to identify those patients who may benefit most from such an intervention.
Pitceathly, C., Maguire, P., Fletcher, I., Parle, M., Tomenson, B., & Creed, F. (2009). Can a brief psychological intervention prevent anxiety or depressive disorders in cancer patients? A randomised controlled trial. Annals of Oncology, 20, 928–934.
To test the hypothesis that a brief intervention would be superior to usual care to prevent anxiety or depressive disorders among newly diagnosed patients with cancer
The structured intervention was based on cognitive behavioral therapy geared toward coping and exploring beliefs and thoughts about illness. The first session was 90 minutes in person with a therapist, followed by two 45-minute sessions two and six weeks later via telephone.
Active treatment phase
A randomized controlled trial design was used.
By the six-month time point, approximately 27% of participants were lost to follow-up or had dropped out of the study for various reasons. Those variables found to predict drop-out were age, gender, previous psychiatric history, and concerns score, some of which were the same variables reported to be predictive of developing an anxiety or depressive disorder.
At the 12-month follow-up, there was no difference between groups. In patients at high risk for developing an anxiety or depressive disorder, those in the intervention group were less likely to develop a disorder (p = 0.05). There was no difference in findings based on the timing of the intervention (immediate – within one week of starting treatment, versus delayed – eight weeks after starting treatment).
The brief intervention studied may have potential for preventing development of anxiety or depressive disorders only in those patients who were at initial high risk for development of those disorders.
Pirl, W.F. (2004). Evidence report on the occurrence, assessment, and treatment of depression in cancer patients. Journal of the National Cancer Institute Monographs, 32, 32–39.
To produce an evidence-based report that reviews empirical literature about depression in patients with cancer and focuses on occurrence, assessment, and treatment
Authors examined literature published January 1966–September 2000. Authors found literature by searching PubMed, PsycINFO, CINAHL, and BiOSIS Citation Index.
The most common intervention for depression is behavioral/cognitive counseling. Because hundreds of articles exist on this topic, the review was limited to several meta-analyses of psychosocial interventions; some measured emotional adjustment or distress rather than depression. All studies cited were conducted prior to 1998. Tools for measuring depression included the Hamilton Rating Scale for Depression, Clinical Global Impression, Hospital Anxiety and Depression Scale, and Montgomery-Asberg Depression Rating Scale. Descriptive reports were found on complementary treatments but no randomized controlled trials (RCTs).
Authors identified 11 RCTs of medication treatment for depression in patients with cancer. The RCTs included data about 755 patients, an average of 58 patients per study.
Some data support the efficacy of psychosocial and pharmacologic treatments for depression in people with cancer. Studies, using antidepressant medications, that conformed to usual practices for antidepressant trials did demonstrate benefit. (The studies that lasted for fewer than five weeks tended to show less benefit than did longer studies.)
RCTs of alternative or complementary interventions were not found.