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Kilgour, R, Jones, D. Keyserlink, J. (2008). Effectiveness of a self-administered, home-based exercise rehabilitation program for women following a modified radical mastectomy and axillary node dissection: A preliminary study, Breast Cancer Research and Treatment, 109(2), 285–295.

Study Purpose

To study the effects of a self-administered home-based exercise video program designed to help women regain shoulder mobility immediately following surgery for modified radical mastectomy and axillary node dissection

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to usual care control or home-based exercise groups. Usual care consisted of standard written information on diet and skin care and a nine-page brochure entitled “Exercise Guide After Breast Surgery”. Participants were not encouraged to follow exercises, nor were they instructed not to do the exercises. The study was conducted during the immediate two-week recovery period following surgery. Over the next 11 days, women assigned to the home-based exercise intervention received the usual care education and followed the home-based exercise video program. Exercises involved upper-extremity movement designed to increase general range of motion, various neck movements, and stretches.

Sample Characteristics

  • The study sample was comprised of female patients.
  • Mean age for the control group was 49.1 years and for the home-based exercise group was 50.6 years.
  • All patients had a modified radical mastectomy with axillary node dissection.
  • Patients were excluded from the study if they had a history or presence of shoulder dysfunction, were older than 65 years, or had sentinel node biopsy dissection only.

Setting

The study took place at an outpatient setting in Montreal, Canada.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • The Oxford Manual Muscle Testing Scale
  • Hand-grip dynamometry
  • Circumferential tape measurements of both extremities
  • Participant self-report using the CR-10 Pain Scale and Borg's Category Scale for Rate of Perceived exertion

Results

The experimental group demonstrated a significantly greater increase in flexion (p = 0.003) and abduction (p = 0.036) of shoulder. There was no significant difference in forearm circumference measurements, external rotation, grip strength, or pain. None of the patients in the home-based exercise group demonstrated any significant change in forearm circumference that would indicate lymphedema. Fifty percent of the patients in the home-based exercise group did not complete exercises because of pain at the shoulder joint and axillary swelling, 25% because of lack of support from family and others, 12.5% for no specific reason.

Conclusions

Self-directed home exercise was associated with greater improvement in some range of motion over time and did not appear to aggravate lymphedema development. There was generally low adherence to the self-directed program.

Limitations

  • The study had a small sample size (N < 30).
  • The study was short, with insufficient evidence about how the program might affect women at longer intervals.
  • Because the control group was aware of the exercise arm of the study, they may have completed more exercise than they otherwise would have, and no control was put in place to not exercise.
  • In the home-based exercise group, 50% did not adhere to the exercise program for a variety of reasons.
  • It is not clear if the exercise program contributed to join pain and axillary swelling experienced by 25% of patients.

Nursing Implications

Poor adherence to the home based self-directed program point to the challenges associated with the approach described in the study.

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Kieviet-Stijnen, A., Visser, A., Garssen, B., & Hudig, W. (2008). Mindfulness-based stress reduction training for oncology patients: Patients’ appraisal and changes in well-being. Patient Education and Counseling, 72, 436–442.

Intervention Characteristics/Basic Study Process

The MBSR intervention emphasized the following.

  • Learning to meditate
  • Systematic monitoring of the body
  • Exploring one’s limits and trying to shift these limits
  • Recognizing and investigating thoughts and cognitions
  • Recognizing daily stress inducing conditions and their emotional impact
  • Learning more ways to handle daily stress

The intervention was offered in eight weekly sessions that were each 2.5 hours in length. Participants were encouraged to practice at home for 45 minutes using an exercise CD and other homework assignments. Each training group was guided by two therapists experienced in working with patients with cancer. Outcomes were assessed at baseline, at week 8, and a year after intervention.

The intervention was modeled after the MBSR program at the Stress Reduction and Relaxation Clinic, Massachusetts Medical Center as described by Kabat-Zinn (1990).

Sample Characteristics

  • N = 47
  • MEAN AGE = 48.4 years
  • AGE RANGE = 31–65 years
  • MALES: 72%
  • KEY DISEASE CHARACTERISTICS: Patients with cancer with multiple diagnoses, the most common being breast cancer (40%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Undergoing treatment (e.g., chemotherapy, hormonal therapy, radiation treatment, surveillance, alternative/complementary) throughout the intervention period.

Setting

Not described

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

  • Pre-post intervention study

Measurement Instruments/Methods

  • Profile of Mood States (POMS)

Results

The MBSR intervention did not significantly improve fatigue outcomes for patients at the eight-week intervention end-point or at one-year follow-up.

Limitations

  • Lack of a neutral comparison group
  • Observed changes in quality of life may be a consequence of the passage of time.
  • Participants were self-referred to program.
  • High dropout rate observed throughout the study (no significant differences in demographic characteristics, disease variables, and well-being scores observed between completers and non-completers)
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Kietpeerakool, C., Supoken, A., Laopaiboon, M., & Lumbiganon, P. (2016). Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer. Cochrane Database of Systematic Reviews, 2016, CD011732. 

Purpose

STUDY PURPOSE: To assess the effects of tranexamic acid for reducing blood loss in women undergoing surgery for advanced ovarian cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Cochrane Collaboration Medline, EMBASE, several online resources, and handsearching from conferences and citations
 
KEYWORDS: Detailed search terms per database are provided.
 
INCLUSION CRITERIA: RCT, comparison of tanexamic acid compared to placebo or no treatment

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 18
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Handbook for Systematic Reviews was used to identify risk of bias.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 1
 
TOTAL PATIENTS INCLUDED IN REVIEW = 100

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Preoperative tranexamic acid was associated with reduced loss of blood compared to placebo; however, the difference from placebo was not statistically significant, and the difference seen did not demonstrate a clearly clinically important benefit (mean difference = -248.59, 95% CI [-550.9, 53.79]). Average number of RBC units were not different between groups, although the rate of RBC transfusion was lower in those given tranexamic acid.

Conclusions

Evidence regarding the effectiveness of tranexamic acid from this review is inconclusive because only one study was found and reviewed.

Limitations

  • Single study in the review
  • Risk of bias related to most of the evaluated outcomes was deemed high, and the overall quality of evidence was low.

Nursing Implications

This review provided no new information to evaluate efficacy of tranexamic acid for prevention of bleeding.

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Kienzle-Horn, S., Vix, J.M., Schuitjt, C., Peil, H., Jordan, C.C., & Kamm, M.A. (2007). Comparison of bisacodyl and sodium picosulfate in the treatment of chronic constipation. Current Medical Research and Opinion, 23, 691–699.

Study Purpose

To compare the safety and efficacy of bisacodyl and sodium picosulphate.

Intervention Characteristics/Basic Study Process

Patients received 5 to 10 mg of bisacodyl sugar-coated tablets or sodium picosulphate drops daily over four weeks. The study schedule included four visits: an initial screening visit followed by a seven-day baseline period, a randomization visit (1:1 basis) and two follow-up visits on days 15 and 29.

Sample Characteristics

  • The study reported on a total sample of 144 patients with chronic constipation, defined as fewer than three stools per week for at least six months, or pain or straining with bowel movements for six months.
  • Patients were aged older than 18 years (range 23–64).
  • The study comprised 70 patients in the bisacodyl group ( 21 men and 49 women) and 74 patients in the sodium picosulphate group (19 men and 55 women).
  • Patients were included in the study if they were aged 18 years or older and had a confirmed diagnosis of chronic constipation. 
  • Patients were excluded if they had a history of organic disease of the colon, ileus, any acute surgical abdominal conditions, organic diseases of the rectum and anus, presence of active gastrointestinal disease, obstruction or dehydration, ingestion of any drug affecting gastrointestinal motility, hypersensitivity to triarylmethane compounds, and recent use (within the past seven days) of bisacodyl or sodium picosulphate.

Setting

15 centers (outpatient clinics and specialist gastroenterology units) in Germany

Study Design

This was a phase IV, open-label, randomized, parallel group study.

Measurement Instruments/Methods

  • Primary efficacy was assessed as number of bowel movements per day and daily stool consistency using a five-point scale (from liquid to hard).
  • Secondary efficacy was assessed as degree of straining using a scale from 0 (absent) to 5 (severe) and physician global efficacy assessment.
  • Safety assessments included adverse-event monitoring, tolerability, and changes in laboratory parameters.
  • Physical examination and blood samples were completed on days 1, 15, and 29.

Results

  • Demographic distribution and baseline characteristics of the two treatment groups were similar.
  • Stool frequency and consistency and occurrence of straining after 14 and 28 days was significantly improved for both groups compared to baseline (p < 0.0001).
  • Physician global rating improved in 74.6% of patients in the bisacodyl group and 79.2% of patients in the sodium picosulphate group.

Conclusions

Bisacodyl and sodium picosulphate are equally tolerated and effective in the treatment of chronic constipation.

Limitations

  • The study lacked a placebo group.
  • Secondary efficacy parameters were subjective, but generally accepted.
  • The study evaluated safety over 28 days and did not address potential long-term changes in gastrointestinal mucosa.
  • No patients with cancer or opioid-induced constipation were included in the study.
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Kienzle-Horn, S., Vix, J.M., Schuitjt, C., Peil, H., Jordan, C.C., & Kamm, M.A. (2006). Efficacy and safety of bisacodyl in acute treatment of constipation: A double-blind, randomized, placebo-controlled study. Aliment Pharmacology and Therapeutics, 23, 1479–1488.

Study Purpose

To determine the effect and safety of oral bisacodyl on stool frequency and consistency.

Intervention Characteristics/Basic Study Process

Patients received bisacodyl 10 mg (two 5-mg tablets) or placebo (two tablets) orally once daily on three successive days following a three-day run-in period. The study had a three-day baseline period and three treatment days. Patients were asked not to drink milk or take antacids at the same time as study medications because they could dissolve the enteric coating. Randomization was 1:1. Unused medication was collected at the end of the treatment period. Primary endpoints during the three-day treatment period were mean number of stools per day and mean stool consistency.

Sample Characteristics

  • The study reported on a sample of 54 Caucasian patients with idiopathic constipation, aged 19 to 89 years.
  • The bisacodyl group (n = 27) comprised 19 women and 8 men, whereas the placebo group (n = 27) comprised 20 women and 7 men.
  • Patients were included in the study if they were aged 18 years or older, had a documented history of constipation well known to the investigator, and were otherwise in good health.
  • Patients were excluded if they had constipation associated with drug treatment, organic disease (e.g., tumors), strictures, inflammatory disease, obstructive conditions, other gastrointestinal (GI) disorders, history of GI surgery, or pregnancy.

Setting

Eight primary care practices in Germany

Study Design

This was a phase IV, multicenter, double-blind, randomized, placebo-controlled, parallel group design study.

Measurement Instruments/Methods

  • Constipation was defined as fewer than three bowel movements per week on average during the past three months, or excessive need for straining, hard stool, low-stool weight, or sensation of incomplete evacuation in more than 25% of evacuations.
  • Patients recorded stool frequency and consistency and adverse events in a bowel diary.
  • Blood specimens (complete blood counts and chemistries) were obtained.
  • Global assessment of efficacy was made by the investigator based on severity of constipation compared with baseline on a four-point Likert-type scale.

Results

  • Twenty-seven patients were evaluable in each group for efficacy.
  • Two patients were excluded secondary to taking restricted concomitant medications.
  • One subject was lost to follow-up before taking study medication.
  • Patient demographics were comparable.
  • Mean number of stools per day was significantly greater in the bisacodyl group (1.8, SD = 1.5) compared to placebo (0.95, SD = 0.6) over the treatment phase (p = 0.0061).
  • Mean stool consistency score improved from hard at baseline for both groups to soft and well formed (2.8, SD = 1.1) during bisacodyl treatment, remaining from moderately hard to hard for placebo (4.2; p < 0.0001).
  • In terms of global efficacy assessment, 19 of 27 patients in the bisacodyl group compared to 14 of 27 patients in the placebo group were assessed as significantly or somewhat improved; the finding was not statistically significant (p = 0.423).

Conclusions

Bisacodyl is effective and safe in improving stool frequency and consistency.

Limitations

  • The power analysis needed 28 patients per group, but only 27 patients per group completed the study.
  • All patients were Caucasian.
  • The sample was predominantly female, which is reflective of a higher proportion of women experiencing constipation in the general population.
  • Although adverse events were reported, no evidence suggested patients were specifically asked about abdominal cramping and flatulence, which were listed as objective rather than subjective symptom data by the authors.
  • Patients in the study were in good health; therefore, patients with cancer were excluded.
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Kiecolt-Glaser, J.K., Bennett, J.M., Andridge, R., Peng, J., Shapiro, C.L., Malarkey, W.B., . . . Glaser, R. (2014). Yoga’s impact on inflammation, mood, and fatigue in breast cancer survivors: A randomized controlled trial. Journal of Clinical Oncology. Advance online publication.

Study Purpose

To assess the effects of yoga on inflammation, mood, and fatigue and to test the hypothesis that yoga would decrease inflammation, depressive symptoms, and fatigue in breast cancer survivors

Intervention Characteristics/Basic Study Process

Women were randomly assigned to the intervention group or a wait-list control group. The intervention consisted of two 90-minute Hatha yoga sessions per week for 12 weeks delivered in a group setting. Sessions were audiotaped, and 50% were randomly assessed for differences from predetermined poses to assess fidelity of the intervention. Yoga teachers called anyone who missed a class. Home practice was encouraged, and all practice times were recorded by participants in weekly logs. Data were collected at baseline, immediately after the intervention, and after three months post-treatment.

Sample Characteristics

  • N = 186 (completed initial data), 181 (finally included)
  • MEAN AGE = 51.6 years (SD = 9.2 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer survivors who had completed cancer treatment within the past three years and were at least two months post-treatment intervention (other than tamoxifen or aromatase inhibitors)
  • OTHER KEY SAMPLE CHARACTERISTICS: Those who already completed five hours or more of vigorous physical activity per week were excluded. Those with any prior yoga practice for more than three months were excluded. The majority of participants were college graduates, were employed full or part time, and were married. The average time since treatment was 10.9 months (SD = 7.9 months).

Setting

  • SITE: Single-site
  • SETTING TYPE: Outpatient
  • LOCATION: Ohio, United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

Single-blinded, randomized, controlled trial

Measurement Instruments/Methods

  • Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF)
  • Short Form (SF-36)
  • Center for Epidemiological Studies Depression Scale (CES-D)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Fasting blood samples for proinflammatory cytokines

Results

Patients attended a median of 79% of yoga classes and reported an average of 24.69 minutes of practice per day at home and in class over 12 weeks. Immediately after the intervention, there were no differences between the groups in fatigue; however, in the yoga group, fatigue was significantly lower at three months (Cohen’s d = -0.36, p = 0.002). Vitality in the yoga group was significantly higher immediately post-treatment and at three months (p = 0.01). There were no differences between the groups in depressive symptoms. Immediately postintervention, there were no differences between groups in cytokine levels; however, at three months, the yoga group had significantly lower cytokine levels compared to the control group (p < 0.05). Yoga participants reported improved sleep compared to patients in the control group (p = 0.03).

Conclusions

Yoga was associated with reduced fatigue, increased vitality, improved sleep, and reduced cytokine levels. Yoga did not appear to have an effect on depressive symptoms in this study.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Other limitations/explanation: The sample included only women who were highly educated and had higher income levels.

Nursing Implications

The findings of this study demonstrated that yoga practice was effective in reducing fatigue and improving vitality and sleep in this patient population. Nurses can suggest that patients become involved in yoga practice as a way to manage fatigue and sleep disturbance. These findings also suggest that yoga can have an impact on subclinical inflammation, which may be a mechanism that fuels fatigue and the decline of physical function.

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Kidd, F., Buttner, C., & Kressel, A.B. (2007). Construction: A model program for infection control compliance. American Journal of Infection Control, 35, 347–350.

Study Purpose

This study describes a five-year expansion project to build a nine-story employee garage, a new post-anesthesia care unit, a new cardiothoracic intensive care unit, and expansion of existing operating room space to include eight new operating rooms. The construction plan included demolition of five circa 1910 mostly unused buildings.

Intervention Characteristics/Basic Study Process

One infection control practitioner (ICP) attended a University of Minnesota Health Care Facility Construction Management Indoor Air Quality Workshop.

An infection control education program for contractors was developed that all construction workers were required to complete the training prior to working on the construction project and annually thereafter.
The infection control training takes 30 minutes. The lesson plan is organized by sections that include precautions to take before, during, and after construction work. There also is an audiovisual program about Aspergillus and its transmission and the susceptibility of immunosuppressed patients.

An infection control team including the general contractor, project manager, ICP, and operating room nurse planner make rounds weekly or daily on all projects to monitor for compliance and answer questions. In addition, other precautions were implemented since patients could not be relocated away from the area of greatest activity.

  • All windows adjacent to the demolition site were sealed with plastic.
  • Prevailing wind direction was monitored, and extra pre-filters were added to all air intakes.
  • Any dust generated during demolitions was wetted down.
  • Air curtains were added to doorways directly facing the construction.
  • Immunosuppressed patients were notified to wear N95 protection when entering the hospital.

Sample Characteristics

Members of the design and construction department are engineers and architects and have attended classes on construction and infection control.

Setting

  • The University Hospital is a tertiary care hospital in Cincinnati, Ohio. It has a level 1 trauma center, seven intensive care units, including a level 3 perinatal research center and neonatal intensive care unit and an adult burn unit.  
  • There is an average daily census of 400.
  • Parts of the original hospital were built in 1910, 1927, and 1969.  
  • At any one time there are 4–6 major renovation projects.

Results

During the first four years of demolition and renovation, the University Hospital had no nosocomial Aspergillus infections.

In the fifth year, of construction, two patients who had possible hospital-acquired infections were identified. An industrial hygienist was brought in to evaluate intervention and make recommendations, but nothing of concern was found.

Particle sampling remained the same from pre-construction to post-construction.

Both possible nosocomial Aspergillus infections occurred after a building that was connected to the hospital and shared air space began a large renovation project without using infection control prevention.

Conclusions

Hospitals must be aware not only of what is happening inside their own facilities, but also what is happening outside. ICPs must establish collegiality with contractors, architects, maintenance, and engineering personnel to produce an effective, comprehensive infection-prevention atmosphere during construction and renovation.

Limitations

  • Small study of one hospital initiative
  • Case study
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Khurana, H., Pandey, R., Saksena, A., & Kumar, A. (2012). An evaluation of vitamin E and pycnogenol in children suffering from oral mucositis during cancer chemotherapy. Oral Diseases.

10.1111/odi.12024

Study Purpose

Evaluate and compare effectiveness of topical vitamin E and pycnogenol (pine bark extract) in treatment of chemotherapy-induced oral mucositis.

Intervention Characteristics/Basic Study Process

Children were randomly assigned to the use of vitamin E, pycnogenol, or sterile water rinses. All were also to follow a uniform oral care protocol, including brushing with a soft tooth brush and chlorhexidine mouth rinse 3 times/day. All study interventions were applied topically three times a day using a dropper. Medications were stored in a refrigerator before usage. The medication was kept in the patient’s mouth for 30 seconds and then swallowed. Patients were blinded to the treatment group. Patients were followed for seven days.

Sample Characteristics

The study was comprised of 72 patients, with a mean age of 9.25 and a range of 6-15 years.

MALES 79%, FEMALES 21%

KEY DISEASE CHARACTERISTICS: All had hematological cancers, including ALL, AML, and NHL, and all were in induction or intensification phases of treatment.

Setting

SITE: Single site

SETTING TYPE: Multiple settings

LOCATION: India

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Pediatrics

Study Design

 Single, blind, randomized placebo controlled

Measurement Instruments/Methods

  • WHO oral mucositis grading scale
  • Oral Mucositis Assessment Scales (OMAS)
  • Children’s International Mucositis Evaluation Scale
     

Results

Mucositis grades in those receiving either vitamin E or pine bark extract were significantly lower than those on placebo (p </= 0.006). OMAS scores declined significantly and consistently across days 1-7, while these scores remained the same in the placebo group. There was significant improvement in pain scores in both intervention groups from day 4 onward, compared to placebo. There were no significant differences in study outcomes between those treated with vitamin E or pine bark.

Conclusions

Topical vitamin E and pine bark extract (pycnogenol) were of benefit in reducing severity of mucositis and pain associated with mucositis in these patients.

Limitations

  • Small sample (<100)
  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results.*
  • Other limitations/*explanation. Short study duration. Baseline mucositis scores not described, and it is not known if there were differences between study groups at baseline. ANOVA was used, but it is not clear what the potential time effect was, as mucositis declined in all subjects. Patients were blinded, but evaluators were not. There is no information provided regarding compliance with the oral care regimen, though it is stated that compliance was evaluated, it is not clear how. There is no information provided about use of analgesics.

Nursing Implications

Topical vitamin E and pine bark extract may have some promise for the management of oral mucositis. Further research on these interventions is warranted.

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Khouri, V.Y., Stracieri, A.B., Rodrigues, M.C., Moraes, D.A., Pieroni, F., Simoes, B.P., & Voltarelli, J.C. (2009). Use of therapeutic laser for prevention and treatment of oral mucositis. Brazilian Dental Journal, 20(3), 215–220.

Study Purpose

To evaluate the frequency and evolution of oral mucositis (OM) among stem cell transplant recipients subjected to therapeutic laser versus mucositis formula

Intervention Characteristics/Basic Study Process

Patients (n = 22) were randomly assigned to control or low level laser therapy (LLLT) daily. The treatment phase for both groups began with the initial clinical manifestations of mucositis with follow up until day +15 after transplant. Two types of laser were used on alternate days, one indicated for tissue repair and the other for analgesia.

Sample Characteristics

  • The study reported on 22 patients with a mean age of 27.5–32.7 years.
  • The sample was 23% female and 77% male.
  • Patients had hematologic malignancies and were receiving the myeloablative conditioning regimen and allogeneic stem cell transplant.
  • All patients were given preventive treatment consisting of soft-bristled toothbushes and saline rinses four times daily followed by benzidamine solution, which was replaced with a 0.12% chlorhexidine gluconate solution toward the end of the study.
  • The control group received the standard of care with the mucositis formula (antiinflammatory [benzidamine], antifungal [nistatin], and anesthetic [neututocain] with distilled water).

Setting

This was a single-site conducted in the bone marrow transplant unit (BMTU) of the University Hospital School of Medicine of Ribeirao Preto (UHSMRP) at the University of São Paulo in Brazil.

Study Design

The study was a randomized controlled trial.

Measurement Instruments/Methods

  • The World Health Organization (WHO) Oral Toxicity Scale and Oral Mucositis Assessment Scale (OMAS) were used.
  • Patients in the laser group completed questionnaires about laser therapy.

Results

The laser treatment group had lower frequency of oral mucositis (p = 0.02) and a lower mean grade of mucositis (p < 0.01).

Conclusions

The inclusion of LLLT was effective in lowering the frequency and treating oral mucositis in patients being treated with high dose myeloablative chemotherapy in preparation for stem cell transplant.

Limitations

  • The sample size was small with fewer than 30 patients.
  • The control group did not receive sham treatment, so the study was not blinded.
  • Authors did not describe the areas that were treated with lasers.

Nursing Implications

Laser therapy is effective in the treatment of mucositis, but it is very high tech and requires special equipment and highly trained personnel.

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Khojasteh, N.H., Zakerinia, M., Ramzi, M., & Haghshenas, M. (2000). A new regimen of MESNA (2-mercaptoethanesulfonate) effectively prevents cyclophosphamide-induced hemorrhagic cystitis in bone marrow transplant recipients. Transplantation Proceedings, 32, 596.

Intervention Characteristics/Basic Study Process

Mesna was given to patients undergoing allogeneic bone marrow transplantation and administered high-dose chemotherapy. Doses were administered at 400 mg/m2 at hours 0, 1, 3, 5, 8, 11, 14, 17, and 20. Fluid also was administered at 3,000 mL/m2.

Sample Characteristics

  • N = 11 patients
  • KEY DISEASE CHARACTERISTICS: Four patients had leukemia; others had nonmalignant disorders.

Study Design

  • Prospective, experimental, nonrandomized, convenience sample

Measurement Instruments/Methods

  • Clinical signs and symptoms
  • Daily urinalysis
  • Observed drop in hemoglobin level
  • Patients evaluated for 60 days

Results

Three patients developed transient but asymptomatic hemorrhagic cystitis. One patient developed late onset but moderate hemorrhagic cystitis.

Limitations

  • Very small sample size
  • Only four patients with cancer
  • Mesna hours different than published guidelines
  • Patients with leukemia not separated in the analysis
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