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Oshima, K., Takahashi, T., Mori, T., Matsuyama, T., Usuki, K., Asano-Mori, Y., . . . Kanda, Y. (2010). One-year low-dose valacyclovir as prophylaxis for varicella zoster virus disease after allogeneic hematopoietic stem cell transplantation. A prospective study of the Japan Hematology and Oncology Clinical Study Group. Transplant Infectious Disease, 12, 421–427.

Study Purpose

To determine the cumulative incidence of varicella-zoster virus (VZV) two years after transplant.

Intervention Characteristics/Basic Study Process

Following allogeneic hematopoietic stem cell transplant (HSCT), patients received low-dose valacyclovir (VCV) for prophylaxis against VZV.  Up to day 35, patients received oral acyclovir (ACV) 1,000 mg/day, and then from days 36 to 365, they received oral VCV 500 mg/day three days a week.  Patients were monitored for VZV for two years after HSCT.

Sample Characteristics

  • Forty adult patients (57% male, 43% female) were included.
  • Median age was 43 years (range 18–61).    
  • Diagnosis for transplant: ten patients had acute myeloblastic leukemia, eight had acute lymphoblastic leukemia, four had chronic myelogeneous leukemia, five had myelodysplastic syndrome, nine had Hodgkin lymphoma, one had multiple myeloma, and three had severe aplastic anemia.
  • Patients were excluded if they had renal or liver dysfunction, antithymocyte globulin, T cell-depleted graft, cord blood, or a hematologic malignancy and were not in remission prior to HSCT.
  • Patients from ages 16 to 70 who were seropositive for VZV-IgG antibody prior to allogeneic HSCT.  Those enrolled were not necessarily as young or as old as the eligibility criteria.

Setting

  • Multi-site
  • Hospitals participating in the Japan Hematological Oncology Clinical Study Group

Phase of Care and Clinical Applications

  • Patients were undergoing posttransplant care.
  • The study has clinical applicability for antimicrobial prophylaxis in a transplant setting.

Study Design

This was a prospective, nonrandomized study.

Measurement Instruments/Methods

  • Development of VZV    
  • Dermal development of VZV (defined as generalized cutaneous distribution or characteristic vesicular skin lesions on an erythematous base within a dermatome)
  • Visceral development of VZV
  • Toxicities of VCV
  • Postherpetic neuralgia
     

Results

Breakthrough VZV occurred in two patients while receiving VCV.  After stopping VCV prophylaxis, an additional five patients developed VZV disease.  These seven patients had a favorable response to oral or intravenous VCV given at therapeutic doses.  Univariate analysis revealed no factors that significantly associated patients with incidence of VZV.

Conclusions

For patients undergoing allogeneic HSCT, one year of low-dose VCV is safe and effective for preventing VZV.

Limitations

Small sample size

Nursing Implications

Patients undergoing allogeneic HSCT may benefit from the safe use of low-dose prophylactic VCV (500 mg/day three times a week) for VZV in the posttransplant setting.

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Osborn, R.L., Demoncada, A.C., & Feuerstein, M. (2006). Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: Meta-analyses. International Journal of Psychiatry in Medicine, 36, 13–34.

Purpose

To investigate the effects of cognitive behavioral therapy (CBT) and patient education on depression, anxiety, pain, physical functioning, and quality of life (QOL) in adult cancer survivors

Search Strategy

The study involved searching MEDLINE, PsycINFO, and the Cochrane Database for the period 1993–2004.

Literature Evaluated

The literature evaluated included 15 randomized controlled trials (RCTs), five of which measured depression and all of which had been published 1993–2004. Authors assessed quality of the RCTs by means of the Jadad scale.

Sample Characteristics

The sample size was 1,492.

Conclusions

CBT is related to short-term effects on depression; individual interventions were more effective than group interventions. Neither CBT nor patient education produced significant long-term effects on depression.

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Osborn, R.L., Demoncada, A.C., & Feuerstein, M. (2006). Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: Meta-analysis. International Journal of Psychiatry in Medicine, 36, 13–34.

Purpose

To investigate the effects of cognitive behavioral therapy (CBT) and patient education (PE) on anxiety in adult cancer survivors

Search Strategy

Databases searched were MEDLINE, PsycINFO, and the Cochrane Database (1993–2004).

Search keywords were cancer, anxiety, depression, quality of life (QOL), fatigue, stress, pain, physical function, social, self-management, evidence-based, interventions, and random/randomized.

Studies were included in the review if they

  • Reported on adult patients with cancer (all types and stages)
  • Had a control group, randomization, and measurable outcomes of interest (anxiety, depression, fatigue, QOL, physical function, and pain)
  • Had at least one follow-up assessment beyond post-treatment, which allowed for examination of duration of effects.

Studies were excluded if they were not randomized or controlled, had a score of less than four on checklist, did not report follow-up data, or did not report data on targeted outcomes.

Dissertations were excluded.

Literature Evaluated

  • A total of 592 studies were evaluated, with only 19 studies meeting criteria. Comprehensive meta-analysis was used to determine effect size for each outcome.
  • Quality was assessed by a modified version of Jadad’s six-item checklist (randomization, double blinding, descriptions of withdrawals and dropouts, statistical analyses, inclusion and exclusion criteria, and adverse effects).
  • Longitudinal study: Times of measurement varied from one week to 14 months. Median follow-up was defined as short-term (less than eight months) and long-term (more than eight months).
  • Four studies reviewed used CBT for anxiety.
    • CBT sessions varied from four weekly one-hour sessions to 55 weekly two-hour sessions.
    • CBT included stress management and problem-solving approaches.
  • One study reviewed used PE for anxiety.
    • PE sessions varied from one 20-minute session to six weekly one-hour sessions.
    • PE included information about illness, symptom management, and discussion of treatment options using booklets, videos, and other educational materials.

Sample Characteristics

  • The review reported on 1,492 adult cancer survivors.
  • All types and stages of cancer were represented.
  • Survivor age range was 18–84 years.
  • 790 survivors were assigned to interventions, and 702 were assigned to control (medical management only).

Results

  • CBT interventions on anxiety (four studies):
    • Large effect was noted for individual and group CBT (g = 1.99, p < 0.01; 95% CI 0.693.31).
    • Of these four studies, a sensitivity analysis revealed a large effect size for individual treatment (g = 2.41, p < 0.01; 95% CI 1.23.55) and no effect for group interventions (d = 0.03, p+0.82; 95% CI -0.200.25).
    • Forest plots representing the effect sizes of CBT on anxiety favor the intervention.
  • The single trial using PE to decrease anxiety resulted in no short-term effect on anxiety and did not include long-term follow-up on anxiety (d= -0.02, p = 0.89; 95% CI -0.360.31).

Limitations

  • Analysis did not consider patient adherence to pharmacologic interventions, which is known to be modest in medical patients.
  • No cost-benefit implications were noted.

Nursing Implications

CBT is effective for short-term management (less than 8 months) of anxiety. Individually based interventions were more effective than those delivered in a group format. Various CBT approaches provided in an individual format can assist cancer survivors in reducing the emotional distress of anxiety.

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Osborn, Demoncada, Feuerstein, 2006

Purpose

Meta-analysis investigating effects of cognitive behavioral therapy (CBT) and patient education (PE) on anxiety in adult cancer survivors

Search Strategy

The search included databases from 1993-2004: Medline, PsychINFO, and the Cochrane Database. Search words used: cancer, anxiety, depression, quality of life (QOL), fatigue, stress, pain, physical function, social, self-management, evidence-based, interventions, and random/randomized.

Literature Evaluated

Inclusion Criteria: adult patient with cancer (all types of cancer and all stages), control group, randomization, measurable outcomes of interest (anxiety, depression, fatigue, QOL, physical function, and pain) and at least one follow-up assessment beyond post-treatment, which allowed for examination of duration of effects.

Sample Characteristics

Quality assessed by modified version of Jadad six-item checklist (randomization, double blinding, descriptions of withdrawals and dropouts, statistical analyses, inclusion and exclusion criteria, and adverse effects). Studies were excluded if not randomized or controlled, or had score less than four on checklist, or did not report follow-up data, or did not report data on targeted outcomes. Dissertations excluded

Results

CBT interventions on anxiety (four studies) Individual and group CBT: Large effect noted (g=1.99, p 0.01; 95% CI 0.69-3.31) Of these four studies, a sensitivity analysis revealed a large effect size for individual treatment (g=2.41, p0.01; 95% CI 1.2-3.55) and no effect for group interventions (d=0.03, p+0.82; 95% CI -0.20-0.25) Forest plots representing the effect sizes of CBT on anxiety favor the intervention.

Conclusions

Significance to practice: CBT is effective for short-term management (8 months) of anxiety. Individually based interventions were more effective than those delivered in a group format. Various CBT approaches provided in an individual format can assist cancer survivors in reducing the emotional distress of anxiety.

Limitations

The single trial using PE to decrease anxiety resulted in no short-term effect on anxiety and did not include long-term follow up on anxiety (d= -.02, p= 0.89; CI-0.36-0.31). Analysis did not consider patient adherence to pharmacologic interventions, which is known to be modest in medical patients.

Nursing Implications

No cost-benefit implications.
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Oren, I., Rowe, J. M., Sprecher, H., Tamir, A., Benyamini, N., Akria, L., . . . Dann, E. J. (2006). A prospective randomized trial of itraconazole vs fluconazole for the prevention of fungal infections in patients with acute leukemia and hematopoietic stem cell transplant recipients. Bone Marrow Transplantation, 38, 127–134.

Study Purpose

To determine whether itraconazole is superior to fluconazole in the prevention of invasive fungal infections, particularly invasive aspergillosis, in hematopoietic stem cell transplant (HSCT) recipients and patients with acute leukemia (AL).

Intervention Characteristics/Basic Study Process

Patients were stratified to either high or low risk based on type of therapy or disease.  High risk included patients undergoing allogeneic HSCT or patients with relapsed/resistant AL.  Low risk included patients undergoing autologous HSCT or newly diagnosed patients with AL receiving induction.  Patients were then randomized to receive either itraconazole or fluconazole prophylaxis in each risk stratum, using a random number generator, in blocks of four.  Intravenous (IV) preparations were used only if the patient could not tolerate oral medications and was switched back to oral as soon as the patient tolerated oral medications.  Antifungal prophylaxis was continued until the resolution of neutropenia, for a maximum of eight weeks. Antibacterial prophylaxis was not administered.  Fluconazole was given in a dose of 400 mg once daily, and itraconazole was given at 200 mg twice daily.

Sample Characteristics

  • One hundred ninety-five patients were included.
  • Median patient age was 49 (range 18–73) in the fluconazole arm and 50 (range 17–75) in the itraconazole arm.
  • In the fluconazole arm, 56% of patients were male and 43% were female.  In the intraconazole arm, 63% of patients were male and 33% were female.
  • Patients received autologous HSCT (56% in the fluconazole group, 52% in the itraconazole group), allogeneic HSCT (19% in the fluconazole group, 18% in the itraconazole group), haploidentical HSCT (3% in the fluconazole group, 4% in the itraconazole group), or no transplant (21% in the fluconazole group, 22% in the itraconazole group).  Per the above criteria, patients were considered low-risk (74% in the fluconazole group, 72% in the itraconazole group) or high-risk (25% in the fluconazole group, 24% in the itraconazole group).  Mean duration of neutropenia for high-risk patients was 13.4 days (SD = 6.1) in the fluconazole arm and 15.4 days (SD = 9.7) in the itraconazole arm.  Mean duration of neutropenia in low-risk patients was 10.7 days (SD = 6.4) in the fluconazole arm and 10.8 days (SD = 7.0) in the itraconazole arm.  Patients receiving group 1 chemotherapy (consisting of standard induction and consolidation regimens for AL and chemotherapy-based conditioning regimens for autologous bone marrow transplant [BMT]) included 77% in the fluconazole arm and 76% in the itraconazole arm.  Patients receiving group 2 chemotherapy (consisting of total body irradiation-based conditioning regimens for autologous or allogeneic BMT) included 10% in the fluconazole arm and 8% in the itraconazole arm.  Patients receiving group 3 chemotherapy (consisting of reduced intensity or T cell depleted conditioning regimens, which included anti-thymocyte globulin and/or fludarabine for allogeneic or haploidentical BMT) included 12% in both groups.

Setting

  • Single site  
  • Inpatient 
  • This study was conducted at a single hematology and BMT center, comprising a 15-bed BMT unit and an 11-bed hematology unit, on hospitalized patients in these two units, in a protected environment using a high-efficiency particulate absorption filtration system.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized trial comparing oral and IV itraconazole with oral and IV fluconazole.

Measurement Instruments/Methods

Toxicity was graded from 0 to 4 according to the National Cancer Institute Common Toxicity Criteria.

Results

Itraconazole was not found to be more effective than fluconazole in preventing invasive fungal infections (IFIs) in neutropenic patients after chemotherapy for AL or after HSCT.  Both drugs were successful in preventing invasive candidal infections.  Invasive aspergillosis (IA) was not as decreased in the itraconazole arm as expected, although the mortality from IA  was lower in the itraconazole arm.

Conclusions

Fungal prophylaxis is important in patients with AL and those undergoing HSCT.  Both itraconazole and fluconazole seem to be effective in preventing IFIs and IA, but neither appeared to be superior to the other in this study.  Itraconazole seems to be less well tolerated in the oral form due to gastrointestinal side effects, although none were significant.  Neither drug completely prevented IA, which causes significant morbidity and mortality; therefore, more research is needed for drugs that have better prophylaxis against IA.

Limitations

This was a nonblinded study leading to bias in the assessment of efficacy and adverse events, as well as the evaluation of response and causes for adverse events.  There was a lack of itraconazole blood measurement.  Antifungal prophylaxis was only used during the early period at risk (during the neutropenic period), the high-risk patients, especially, are at risk for significantly more time than just the neutropenic period.  Antifungal prophylaxis should be continued for an extended period after engraftment, especially in patients undergoing allogeneic HSCT.  This information is useful for most hematologic malignancy but may not be generalizable for patients with solid tumors.

Nursing Implications

Education related to antifungal prophylaxis and the necessity of taking these medications is important.  Nurses can educate about the expected side effects, especially the GI side effects of itraconazole when given orally.

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Oremus, M., Dayes, I., Walker, K., & Raina, P. (2012). Systematic review: Conservative treatments for secondary lymphedema. BMC Cancer, 12, 6.

Purpose

STUDY PURPOSE: To examine the effectiveness of conservative treatments for lymphedema


TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, AMED, and CINAHL 1990–January 2010


KEYWORDS: Search terms provided in online file


INCLUSION CRITERIA: RCT or observational study with comparison group, pediatric and adult patients with secondary lymphedema for any reason except filariasis infection


EXCLUSION CRITERIA: Pharmacologic or surgical treatment for lymphedema

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 6,814 articles were evaluated.


EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Jadad scale used for RCTs; Newcastle-Ottawa Scale used  for observational studies

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 44 (32 with cancer)
  • SAMPLE RANGE ACROSS STUDIES: 21–150
  • KEY SAMPLE CHARACTERISTICS: Cancer evidence was in patients with breast cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: Not provided

Results

Six RCTs involving intermittent pneumatic compression (IPC) were used. Two showed IPC had benefit over CDT or self-massage, and three did not show IPC to be any better than massage, skin care, or elastic sleeve; one compared different IPC devices. Six RCTs using massage-based treatments were used, and five showed no benefit. Four studies of low-level laser were used. Three showed low-level laser was superior to exercise, sham laser, or usual care, and one shows that low-level laser was better than sham laser at some time points in the study. Dieting yielded conflicting findings. Equivocal results were seen for ultrasound, modified manual lymph drainage, and compression stockings.

Conclusions

This review provides limited evidence of effects of conservative treatments for lymphedema, and no conclusions about the most effective conservative approach are possible from this review.

Limitations

Most studies had “fair” quality. Follow-up time frames in studies varied considerably. The majority of studies were among breast cancer patients only. It is surprising that this review did not include any studies involving CDT.

Nursing Implications

Findings from this review showed that most interventions reduced limb volume and were not associated with any significant patient harms. Dieting alone does not appear to be particularly effective for limb volume reduction. Patients may benefit from a variety of conservative approaches to manage lymphedema. Ongoing research is needed to determine comparative effects of various approaches.

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Openshaw, H., Beamon, K., Synold, T.W., Longmate, J., Slatkin, N.E., Doroshow, J.H., . . . Somlo, G. (2004). Neurophysiological study of peripheral neuropathy after high-dose paclitaxel: Lack of neuroprotective effect of amifostine. Clinical Cancer Research, 10, 461–467.

Intervention Characteristics/Basic Study Process

Women with breast cancer receiving high-dose infusional paclitaxel (725 mg/m2 for 24 hours) in combination with doxorubicin (165 mg/m2 for 96 hours) and cyclophosphamide (ACT) (100 mg/kg for two hours) were studied on two autologous peripheral blood stem cell transplant protocols—one with and one without amifostine (740 mg/m2 administered over 10 minutes before and 12 hours after initiation of the paclitaxel infusion).

Sample Characteristics

  • N = 31
  • KEY DISEASE CHARACTERISTICS: Women with high-risk breast cancer eligible to receive ACT with or without amifostine, and stable patients with stage IV breast cancer eligible to receive ACT with amifostine

Study Design

Women in each group were evaluated before ACT and 20–40 days later with neurologic examination, a composite peripheral neuropathy score, peroneal and sural nerve conduction studies, and quantitative sensory testing. The same technologist performed all nerve conduction studies.

Results

No significant effect was seen of amifostine on chemotherapy-induced peripheral neuropathy after high-dose paclitaxel in regard to nerve conduction parameters, quantitative sensory testing, or composite neuropathy scores.

Limitations

  • The study’s small sample size and lack of randomization to treatment with amifostine may bias results.
Print

Openshaw, H., Beamon, K., Synold, T.W., Lougmate, J., Slatkin, N.E., Doroshaw, J.H., . . . Somlo, G. (2004). Neurophysiological study of peripheral neuropathy after high-dose paclitaxel: Lack of neuroprotective effect of amifostine. Clinical Cancer Research, 10, 461–467.

Intervention Characteristics/Basic Study Process

Women with breast cancer receiving high-dose infusional paclitaxel (725 mg/m2 for 24 hours) in combination with doxorubicin (165 mg/m2 for 96 hours) and cyclophosphamide (100 mg/kg for two hours; ACT) were studied on two autologous peripheral blood stem cell transplantation protocols, one with and one without amifostine (740 mg/m2 administered over 10 minutes before and 12 hours after initiation of the paclitaxel infusion).

Sample Characteristics

The sample consisted of 31 women with high-risk breast cancer and who were eligible to receive ACT with or without amifostine, and patients with breast cancer who were at stable stage IV and eligible to receive ACT with amifostine.

Study Design

The study had a nonrandomized comparison group design.

Measurement Instruments/Methods

Women in each group were evaluated before ACT and 20–40 days later with neurologic examination, a composite peripheral neuropathy score, peroneal and sural nerve conduction studies, and quantitative sensory testing. The same technologist performed all nerve conduction studies.

Results

No significant effect was noted for amifostine on chemotherapy-induced peripheral neuropathy after high-dose paclitaxel in regard to nerve conduction parameters, quantitative sensory testing, or composite neuropathy scores.

Limitations

The study’s small sample size and lack of randomization to treatment with amifostine may bias results.

Print

Onyechi, K.C., Onuigbo, L.N., Eseadi, C., Ikechukwu-Ilomuanya, A.B., Nwaubani, O.O., Umoke, P.C., . . . Utoh-Ofong, A.N. (2016). Effects of rational-emotive hospice care therapy on problematic assumptions, death anxiety, and psychological distress in a sample of cancer patients and their family caregivers in Nigeria. International Journal of Environmental Research and Public Health, 13, E929. 

Study Purpose

To evaluate the degree to which a rational emotive behavioral approach and techniques can benefit patients and family members in hospice care

Intervention Characteristics/Basic Study Process

A manual for the intervention approach was developed to guide the treatment process. It was based on a cognitive behavioral approach, including cognitive restructuring, confrontation, therapeutic alliance, acceptance, dialogue, reframing, use of metaphors worksheets, and motivational activities. The intervention was provided for 10 weeks in 45-minute sessions weekly, with four weeks of follow-up meetings in each household. Study assessments were conducted at baseline, after the 10-week intervention, and after the four weeks of follow-up, using self-report instruments and structured interviews. Participants randomized to the control intervention received usual care involving spiritual support, caregiving, counseling, etc., for the same amount and duration of time.

Sample Characteristics

  • N = 32 patients and 52 family caregivers   
  • MEAN AGE = 48.33 years (SD = 6.17)
  • MALES: 15.38%, FEMALES: 84.62%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Breast, cervical, and prostate cancers; all patients were at terminal stage of disease. 
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority lived in rural settings.

Setting

  • SITE: Single site   
  • SETTING TYPE: Home    
  • LOCATION: Nigeria

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Patients and Family Caregivers' Assumptions Questionnaire
  • Death Anxiety Questionnaire
  • Kessler Psychological Distress Scale

Results

Overall baseline problematic assumptions and death anxiety were high, and distress scores showed severe distress. Respeated measures analysis of variance (ANOVA) showed that the intervention program had a significant effect on problematic assumptions (p = 0.00), death anxiety (p = 0.00), and distress (p = 0.00) in caregivers and patients compared to those in usual care. This difference was maintained at follow-up.

Conclusions

The findings show that cognitive behavioral techniques and the specific approach used here were effective in reducing problematic assumption, death anxiety, and psychological distress among patients with cancer and their family caregivers.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • The study involved mainly patients and family members living in rural Nigeria; the results may not be applicable to other cultural groups.

Nursing Implications

The findings demonstrated that cognitive behavioral approach techniques are helpful in reducing stress and anxiety in patients in hospice and their informal caregivers. Nurses can incorporate these types of approaches into usual counseling and supportive interventions with caregivers and patients.

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Omidvari, S., Saboori, H., Mohammadianpanah, M., Mosalaei, A., Ahmadloo, N., Mosleh-Shirazi, M.A., . . . Namaz, S. (2007). Topical betamethasone for prevention of radiation dermatitis. Indian Journal of Dermatology, Venereology and Leprology, 73, 209–214.

Study Purpose

To investigate whether the prophylactic use of topical betamethasone 0.1% can prevent acute radiation dermatitis

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of three groups: betamethasone, petrolatum, or no treatment. The treatment delivery protocol was the same for all groups. Education on the amount of skincare product to use was consistent.

Sample Characteristics

  • The study sample (N = 51) was comprised of female patients with breast cancer (stage I or II).
  • Age of the sample ranged from 34–66 years.
  • Patients did not undergo concurrent chemotherapy or systemic corticosteroids.
  • The total radiation dose was 50 Gy to the chest wall, with patients receiving a single 2 Gy per day for five days a week.
  • A cobalt-60 unit was used, which does not have the same skin-sparing abilities of the 3-D conformal or intensity-modulated radiation therapy.

Study Design

The study used a randomized double-blind controlled trial design.

Measurement Instruments/Methods

  • Patients were assessed using the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria for acute radiation dermatitis.
  • Statistical analysis was done using non-parametrical tests (Kruskal-Wallis test and Friedman test).

Results

By the third week (30 Gy), 26.3% of the betamethasone group had grade 1 skin toxicity compared to 64.7% and 66.7% of the petroleum and control groups, respectively (p = 0.027). By the seventh week, 15.8% of the betamethasone patients had grade I skin toxicity, 6.7% of the control group had grade I, and 100% of the petroleum group had grade II or higher.

Conclusions

Acute radiation dermatitis increased over time for all groups. The betamethasone group had lower prevalence at one time point; however, at the end of treatment, acute radiation dermatitis was lower in the untreated controls.

Limitations

  • Skin assessment did not include the inframammary fold.
  • No statement if a patient missed a treatment.
  • Patient perceptions, such as pain or itching, were not addressed.
  • Though the study stated the aim was to prevent acute radiation dermatitis, more than 90% of the sample had grade 2 or higher acute radiation dermatitis at the beginning of the study.
  • The study had no blinding and a small sample size, with less than 100 participants.
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