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Potter, P.J. (2007). Breast biopsy and distress: Feasibility of testing a Reiki intervention. Journal of Holistic Nursing, 25, 238–248.

Study Purpose

To determine the feasibility of testing a Reiki intervention, a complementary therapy, on women undergoing breast biopsy; to determine the effectiveness of a Reiki intervention in the sample

Intervention Characteristics/Basic Study Process

Two-group design: conventional care group (CCG) and Reiki intervention group (RIG)

Sample Characteristics

  • The sample was composed of 32 participants; 17 in RIG and 15 in CCG.
  • Mean participant age was 52 years (SD = 8.86 years); the age range was 37–75 years.
  • All participants were female.
  • Of all participants, 32 were undergoing diagnostic breast biopsy.
  • Most participants were Caucasian: in RIG 13, or 76%, were Caucasian; in CCG, 13, or 87%, were Caucasian.

Setting

  • Multisite
  • Outpatient
  • United States

Phase of Care and Clinical Applications

Diagnostic

Study Design

Randomized controlled single-blind trial

Measurement Instruments/Methods

  • State-Trait Anxiety Inventory (STAI), by Spielberger
  • Center for Epidemiological Studies Depression Scale (CESD)
  • Hospital Anxiety and Depression Scale (HADS)

Results

Neither group displayed significant distress (as operationalized by the three measures) either before or after breast biopsy. Likewise, the study showed no significant difference in any of the measures between groups (RIG and CCG) over time. Over time (pre- to post–breast biopsy), the A state did not decrease significantly in either group (F (2) = 4.78, p = 0.0119) in regard to the HADS total (F (1) = 6.18, p = 0.0187) or HADS anxiety subscale (F (1) = 12.96, p = 0.0011).

Conclusions

One cannot conclude that Reiki was an effective intervention for reducing biopsy-related distress.

Limitations

  • The study had a small sample, with fewer than 30 participants.
  • The degree of blinding is unclear; the study contains contradictory information.
  • Data-collection time points are not clearly described—how long exactly after biopsy, what was the range of time points for collection of T3 data? Furthermore, the author discusses postintervention telephone interviews, but neither the purpose of the interviews nor the data collected in them are reported.
  • Data-collection procedures for the CCG group were not explained: Who was interviewed, both groups or only RIG participants?
  • Many practitioners provided the intervention; treatment variations may have resulted.

Nursing Implications

Findings do not support the effectiveness of Reiki under the conditions of the study.

Print

Potthoff, K., Hofheinz, R., Hassel, J.C., Volkenandt, M., Lordick, F., Hartmann, J.T., Karthaus, M., . . . Wollenberg, A. (2011). Interdisciplinary management of EGFR-inhibitor-induced skin reactions: A German expert opinion. Annals of Oncology, 22, 524–535.

Purpose & Patient Population

To provide interdisciplinary expert recommendations on how to treat patients with skin reactions undergoing anti–epidermal growth factor receptor (EGFR) treatment.

Type of Resource/Evidence-Based Process

The task force prepared the first manuscript based on the data retrieved. All panel members were then asked to agree on a consensus statement following a period of meetings and discussions.

The search strategy included literature published until April 8, 2010, and data presented during the Annual Meeting of the American Society of Clinical Oncology (ASCO) 2008; the World Congress of Gastrointestinal (GI) Cancer, Barcelona 2008; the European Cancer Organisation–15 Congress 2008; ASCO GI 2009; and ASCO 2009.

Databases searched were MEDLINE, the Cochrane Library, Cochrane Central Register of Controlled Trials, and EMBASE: Drugs and Pharmacology.

Guidelines & Recommendations

Acneform Rash:

  • Moisturize.
  • Begin topical antibiotic treatment (erythromycin, metronidazole, or nadifloxacin) twice daily for early-stage skin reactions.
  • Systemic treatment should be started if grade 2 or higher skin reactions occur. Oral tetracyclines (doxycycline or minocycline) are recommended.

Xerotic Skin:

  • Avoid hot showers and excessive use of soaps.
  • Return moisture by applying emollients.

Pruritus:

  • Skin moisturizer
  • Urea or polidocanol-containing lotions

Fissures:

  • Treat topically with propylene glycol 50% in water for 30 minutes under plastic occlusion every night, followed by application of hydrocolloid dressing.

Paronychia:

  • Daily antiseptic baths to avoid bacterial superinfection.

Dermatology Referral:

  • Lesions classified as grade 3 or higher should be managed collaboratively by an oncologist and a dermatologist.

Treatment Adjustments:

  • Perform if skin reaction is grade 3 or higher.

Prophylactic Treatment:

  • A number of unresolved issues remain, including whether or not to give prophylactic agents, and if given, whether to use topical or systemic approaches.

Nursing Implications

To date, no evidence-based treatment algorithms exist for the management of these skin reactions. The most important conclusion from this panel is that EGFR-inhibitor–induced skin reactions can be effectively treated at all stages and grades. The panel recommends to intervene as early as possible at the first sign of dermatologic reactions. Basic skin care combined with a specific therapy adapted to the stage and grade of the skin reaction is recommended. Randomized phase 3 trials are needed to make recommendations on prophylactic treatment.

Print

Postow, M.A. (2015). Managing immune checkpoint-blocking antibody side effects. American Society of Clinical Oncology 2015 Educational Book, 76–83. 

Purpose & Patient Population

PURPOSE: To describe the side-effect profile and discuss treatment strategies to manage immune-related adverse events associated with newer agents
 
TYPES OF PATIENTS ADDRESSED: Cancer patients diagnosed with melanoma

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion

 

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care

Results Provided in the Reference

Unable to discern any information about scope or evidence used in this article. Expert opinion.

Guidelines & Recommendations

Recommendations for the management of mild diarrhea include oral hydration, American Dietary Association diet, and lomotil four times per day. For symptoms that persist for more than three days or increase, oral or IV corticosteroids should be used, although no dosages were noted. For severe cases in which steroids do not improve diarrhea, patients should be hospitalized for IV therapy to include hydration and steroids up to 2 mg/kg twice a day. For symptoms that still persist, infliximab 5 mg/kg once every two weeks can be used.

Limitations

  • Limited clinical experience with immune checkpoint inhibitors
  • Only patients with melanoma were considered.

Nursing Implications

Additional studies need to be conducted to determine the best management practice for gastrointestinal side-effect management with immune-checkpoint blocking antibodies in a variety of cancer types.

Print

Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C., & Lerner, I. (2003). Therapeutic massage and healing touch improve symptoms in cancer. Integrative Cancer Therapies, 2, 332–344.

Intervention Characteristics/Basic Study Process

All participants received four weekly 45-minute sessions of therapeutic massage (MT), healing touch (HT), or presence (P) and four weekly sessions of a standard care control. Credentialed practitioners who were also registered nurses delivered MT and HT. The three interventions all included music, a centering message, and a message to focus on breathing and letting go of extraneous thoughts. The order of the conditions was randomized. MT included a written Swedish massage protocol using massage gel. For HT, the protocol developed by Healing Touch International was used, and touch and nontouch techniques were used. Energy techniques used included centering, unruffling, magnetic unruffling, full-body connection, mind clearing, chelation, and lymphatic drain to modulate the energy field. For P, participants lied on a table listening to relaxing music. An MT or HT therapist sat with the participant during the session. The purpose was to be attentive and caring but to avoid therapy or physical intervention. In the control group, symptoms and vital signs were assessed.

Sample Characteristics

  • Of the 230 adults who consented to participate, 164 completed all eight sessions.
  • Of those who completed the study, mean age was 54.7 years, 87% were female, 98% were Caucasian, and 68% were married.
  • The majority had stage III or IV disease, and 52% had breast cancer.
  • Mean time since diagnosis was 17.4 months.
  • All participants rated fatigue, pain, anxiety, or nausea as greater than 3 on a scale of 0 to 10.

Setting

Patients were from two outpatient chemotherapy clinics in the Midwest.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, two-period crossover (between one of the interventions and standard care) study.

Measurement Instruments/Methods

  • Profile of Mood States (POMS) for fatigue
  • Blood pressure
  • Heart rate
  • Respiratory rate
  • Pain
  • Nausea
  • Medication use
  • Anxiety
  • Mood disturbance
  • Satisfaction

Results

Compared to the control group, there was no effect of presence on fatigue. When comparing individual interventions to their matched control periods, the effect of MT on fatigue was close to significance (p = 0.057). HT was found to reduce fatigue (p = 0.028).

Conclusions

There was no clear evidence that one intervention was superior to the other, but MT and HT seemed to be more effective than presence alone or standard care in improving fatigue.

Limitations

  • Interventions also included centering, breathing, and music, which may confound the results.
  • The commitment to complete the study was great, and the dropout rate was high.
  • Cross-over designs may be more appropriate for healthy participants or those with earlier stage disease.
  • The study design was complex. There was no blinding, there was variability in the research assistant and practitioners collecting assessments, and there was variation in the intervention technique.
  • A greater number of participants assigned to the presence group dropped out due to treatment preference.
  • A registered nurse certified in massage or healing touch therapy is required.
Print

Post-White, J., Kinney, M.E., Savik, K., Gau, J.B., Wilcox, C., & Lerner, I. (2003). Therapeutic massage and healing touch improve symptoms in cancer. Integrative Cancer Therapies, 2, 332–344.

Study Purpose

To determine if massage therapy and healing touch were effective in reducing anxiety, mood disturbance, pain, fatigue, and nausea and in improving the relaxation and satisfaction with care of patients receiving chemotherapy treatment

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to one of three groups: therapeutic massage, healing touch, or caring presence. All received four weekly 45-minute sessions of the intervention and four weeks of standard care (control). After four weeks, patients were crossed over to another intervention or the control. Order of the intervention and usual-care control were randomized. Pre- and post-assessments of pain, nausea, and vital signs were done at each session. Assessments of intervention effects were done at the beginning and end of each four-week session. Therapeutic massage was provided in a standardized fashion, using a Swedish massage protocol. Healing touch followed a previously developed protocol incorporating centering, unruffling, magnetic unruffling, full-body connection, mind clearing, chelation, and lymphatic drain. Presence consisted of patients lying down for 45 minutes with relaxing music and the presence of a therapist. The therapist asked patients how they were feeling and if they had any questions. Conversation may or may not have occurred, according to the patient’s preference; the purpose of the therapist was to be attentive but to avoid therapy or physical intervention. The control condition consisted of usual care, which the authors did not describe.

Sample Characteristics

  • The study reported on a sample of 164 patients.
  • Mean patient age was 57.4 years, with a range of 27–83 years.
  • The sample was 87% female and 13% male.
  • The most common cancer types were breast, gynecologic or genitourinary, gastrointestinal, hematologic, and lung.
  • The majority of patients had stage III or IV disease, and 50% were in the first month of chemotherapy treatment.
  • All patients had a score of at least 3 on a 10-point scale of symptom severity. The most frequently reported symptoms were fatigue, pain, anxiety, and nausea.

Setting

  • Single site
  • Outpatient setting

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

A randomized, controlled, parallel-group, crossover design was used.

Measurement Instruments/Methods

  • Symptom rating scales (0–10)
  • Brief Pain Inventory
  • Brief Nausea Index
  • Profile of Mood States
  • Satisfaction measure according to a four-point Likert-type scale

Results

  • Of those who initially entered the study, 29% dropped out. Half of the dropouts were due to changes in the cancer treatment protocol; half were because patients wanted an intervention different from the one assigned. Those who dropped out had higher pain, nausea, mood disturbance, and fatigue at baseline (p < 0.05) than those who did not.
  • Massage and healing touch groups showed immediate post-session reduction of respiratory rate, heart rate, and blood pressure (p < 0.01), and these interventions were more effective (p < 0.01) in achieving these reductions than were control and presence conditions. Massage and healing touch were associated with pre- and post-session reduction in current pain (p < 0.001).
  • Over the four-week study period, mood disturbance decreased over time in all patients. Massage therapy, compared to the control condition, was more effective at reducing total mood disturbance (p = 0.004) and anxiety (p = 0.023). Healing touch reduced mood disturbance (p = 0.003) and fatigue (p = 0.028).
  • Mean pain scores in all cases declined over time.
  • There were no differences between groups in nausea or use of antiemetics.
  • There were no differences between groups in overall satisfaction. Massage and healing touch were associated with higher satisfaction with the intervention than was presence (p < 0.0001).

Conclusions

Massage therapy and healing touch were more effective than presence alone or standard care in improving mood, reducing anxiety, pain, and fatigue and in reducing heart rate, blood pressure, and respiratory rate immediately postintervention.

Limitations

  • The control condition may not have provided appropriate attentional control.
  • The study had risk of bias due to no blinding.
  • The anxiety measure was not a rigorous, valid tool; it was a 10-point scale.
  • The study had a large drop-out rate.

Nursing Implications

Massage therapy and therapeutic touch can be beneficial to patients because the interventions induce physical relaxation and reduce pain, fatigue, and anxiety. In this study, these interventions were more effective in this regard than was therapeutic presence alone. Massage therapy and therapeutic touch are complementary therapies that nurses can consider and advocate for on behalf of patients who may benefit from them.

Print

Posadzki, P., Moon, T. W., Choi, T. Y., Park, T. Y., Lee, M. S., & Ernst, E. (2013). Acupuncture for cancer-related fatigue: a systematic review of randomized clinical trials. Supportive Care in Cancer, 21, 2067–2073.

Purpose

To review the evidence regarding acupuncture for cancer-related fatigue (CRF).

Search Strategy

Databases searched were PRISMA, AMED, CINAHL, EMBASE, MEDLINE, PsycINFO, Cochrane Collaboration, one Chinese, three Japanese, and four Korean databases.

Search keywords were acupuncture therapy or electroacupuncture, cancer, and fatigue. A full listing of search terms used was provided.

Studies were included in the review if they were randomized, controlled trials (RCTs) investigating the effect of acupuncture treatments on CRF.

The exclusion criteria were not specified.

Literature Evaluated

In total, 2,419 references were retrieved. The Cochrane tool was used to assess research method quality.

Sample Characteristics

  • The final number of studies included was seven RCTs (548 patients).
  • The sample range across studies was not provided.

Results

Of the seven RCTs found for inclusion, four favored acupuncture and three showed no effect. Most studies had serious limitations and methodological flaws. Of the two studies that were of relatively high quality, one showed no benefit over sham acupuncture and one favored the intervention over sham and wait-list control. Three of the four studies that controlled for placebo effect showed no benefit of acupuncture.

Conclusions

The evidence for acupuncture in the management of CRF is ambiguous, conflicting, and inconclusive.

Limitations

  • The review included a small number of studies.
  • The included studies were of low quality. 
  • Heterogeneity among studies precluded meta-analysis.

Nursing Implications

Findings showed that evidence is lacking in support of acupuncture for the management of CRF.

Print

Porter, L.S., Keefe, F.J., Garst, J., Baucom, D.H., McBride, C.M., McKee, D.C., . . . Scipio, C. (2011). Caregiver-assisted coping skills training for lung cancer: Results of a randomized clinical trial. Journal of Pain and Symptom Management, 41, 1–13. 

Study Purpose

To assess the efficacy of two variant cognitive skills training (CST) interventions for the caregivers of patients with lung cancer to improve caregiver distress, self-efficacy, and strain

Intervention Characteristics/Basic Study Process

Following a baseline data collection period, participants (patient-caregiver dyads) were randomly assigned to either CST or a cancer education and support group. Trained research assistants blinded to participant treatment groups collected patient and caregiver assessments via telephone calls immediately after each treatment session and at four months post-study. Fourteen 45-minute, telephone-based sessions with individual dyads using speaker phones occurred over an eight-month period. All study patients continued regular healthcare visits informed by including educational information. Trained, registered nurses adhering to detailed and audiotaped treatment outlines received weekly supervision and evaluation from study psychologists. Dyads in the CST group received information about ways to manage disease symptoms, homework assignments, and a CD focused on stress management. The education and support dyad group received lung cancer disease and treatment information, including hospice and palliative care, in a supportive environment without focus on coping skills training.

Sample Characteristics

  • N = 233 dyads  
  • MEAN CAREGIVER AGE = 59.3 years
  • CAREGIVER MALES: 31%, CAREGIVER FEMALES: 69%
  • KEY DISEASE CHARACTERISTICS: Caregivers of patients with a diagnosis of early stage lung cancer (non-small cell lung cancer stages 1–3 or limited stage small-cell lung cancer); median of 207.5 days since patient diagnosis; 81% with history of cancer surgery; more than half with stage 1 non-small cell lung cancer
  • OTHER KEY CAREGIVER SAMPLE CHARACTERISTICS: 82% Caucasian; 44% college educated; 64% spousal caregivers living with patient

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings  
  • LOCATION: Home telephone intervention, North Carolina

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Randomized, controlled trial with blinding of intervention

Measurement Instruments/Methods

Caregiver assessment only:  
  • Profile of Mood States–B (POMS-B) measuring six aspects of mood (high Cronbach’s alpha)
  • Caregiver Strain Index (CSI) measuring caregiver common stressors (high internal consistency and construct validity)
  • Modified Caregiver Self-Efficacy in Symptom Management (CSESM) measuring caregiver perceived ability to help patient manage disease symptoms (high Cronbach’s alpha)

Results

No significant demographic or medical variable differences existed between dyads in the CST and education and support groups. Caregiver outcome measures indicated significant main effects over time for the POMS-B anxiety subscale (p = 0.02) and self-efficacy (p = 0.01). Both intervention groups showed decreases in caregiver anxiety and increases in their self-efficacy to manage patient symptoms although no significant time to intervention occurred with hierarchical linear modeling. An exploratory moderator analysis showed the education and support intervention to most benefit the caregivers of patients with stage 1 cancer. The CST intervention most benefited the caregivers of patients with stage 2 or 3 lung cancer.

Conclusions

CST and education and support intervention improved patient and caregiver anxiety and efficacy although the lack of a nontreatment group prevented specific conclusions about either intervention approach. Influences of time and attention may have affected dyadic outcomes. More research on important intervention aspects and their operation for improved lung cancer clinical practice is needed.

Limitations

  • Risk of bias (no control group)
  • Findings not generalizable
  • Subject withdrawals ≥ 10% 
  • Other limitations/explanation: The distinction between the education provided to the CST group and the education and support group was not clear.

Nursing Implications

Identifying effective caregiver support interventions to aid in the care of patients with lung cancer remains a priority because of high levels of patient and caregiver distress and low self-efficacy. Additional studies need to include diverse participants, structured protocols for data collection and evaluation, a standard care (control) group, and innovative recruitment and retention methods for caregivers to strengthen the clinical practice evidence for this group of caregivers.

Print

Porter, L.S., Keefe, F.J., Baucom, D.H., Hurwitz, H., Moser, B., Patterson, E., & Kim, H.J. (2012). Partner-assisted emotional disclosure for patients with GI cancer: 8-week follow-up and processes associated with change. Supportive Care in Cancer, 20, 1755–1762.

Study Purpose

To (a) examine data collected eight weeks following participants’ completion of the intervention to determine whether treatment effects were maintained, and (b) process data to identify factors that might explain variability in response to the intervention 

Intervention Characteristics/Basic Study Process

After providing informed consent, participants were administered baseline measures and then randomly assigned to either a partner-assisted emotional disclosure intervention group or an education/support condition group. The partner-assisted emotional disclosure intervention protocol systematically trained couples in skills designed to help patients disclose their feelings and concerns related to the cancer experience.

Individual couples attended four in-person sessions with a master's-level therapist. Sessions included training in communication skills to help patients express their cancer-related thoughts and feelings and partners to encourage patients’ disclosure and communicate understanding and acceptance. The majority of sessions were devoted to couples’ conversations in which patients were given the opportunity to disclose their cancer-related thoughts and feelings to their partners.

Couples in the cancer education/support condition group attended four in-person sessions that centered on presenting information relevant to living with cancer. The therapists and scheduling sessions were the same as for the disclosure intervention. Couples in this condition group did not receive any training in communication skills, and patients were not encouraged to discuss their thoughts and feelings related to the cancer experience with their partners.

Sample Characteristics

  • The sample included 130 couples. 
  • Mean age of patients was 59.4 years; mean age of partners was 59.3 years.
  • The patient sample was 71% male and 29% female; the partner sample was 29% male and 71% female.
  • Patient diagnoses were colorectal cancer (42%), pancreatic cancer (15%), esophageal cancer (11%), and other cancers (32%).
  • The majority of patients were Caucasian, had stage IV disease, and had received chemotherapy; half were educated beyond high school.
  • The majority of partners were Caucasian and were educated beyond high school (60%).

Setting

  • Outpatient setting
  • Duke University and University of North Carolina Hospitals

Phase of Care and Clinical Applications

  • End of life/multiple phases
  • End of life; survivorship; sustained intervention effect

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Quality of Marriage Index (QMI): study Cronbach’s alpha average for both patients and partners = 0.90    
  • Miller Social Intimacy Scale (MSIS): study Cronbach’s alpha average for patients and partners = 0.90
  • Profile of Mood States (POMS): study Cronbach’s alpha average for patients and partners = 0.89
  • Holding Back From Disclosure Measure: study Cronbach’s alpha for patients only = 0.88
  • Positive and Negative Affect Scale (PANAS): noted to have reliability and validity
  • Self-Feeling Awareness Scale (SFAS): inter-rater reliability previously established

Results

The study experienced a 27.7% attrition rate due to patient death or declining health or conflicts between study completion and life issues. Analysis occurred according to an intent-to-treat model based on an initial randomized sample of 130 couples. For couples in which the patient initially reported high levels of holding back from discussing cancer-related concerns, the partner-assisted emotional disclosure intervention led to significant improvement in relationship quality (p = 0.002) and intimacy (p = 0.020) over an eight-week follow-up period compared to an education/support control condition. There was no treatment effect on mood. Overall, the benefits of disclosure intervention appeared largest for patients who were high in holding back.

In patients who were more expressive during disclosure sessions, patients and partners were significantly more likely to report increases in relationship quality and intimacy from baseline to post-treatment assessment. When patients reported more negative affect following the disclosure sessions, both patients and partners were significantly more likely to report decreases in psychological distress between baseline and post-treatment assessment.

Conclusions

The intervention showed a positive effect on couples’ relationships over the eight-week follow-up; however, there was no demonstrated effect on affect or mood disturbance for patients or their partners.

Limitations

  • Some couples were unable to complete the four sessions of the intervention due to the face-to-face structure of the intervention.
  • The large amount of data collected by telephone contact at eight weeks postintervention may influence the accuracy of data.
  • Whether partners were also caregivers for patients at the end of life is unclear. 
  • Participants tended to be white, well-educated, heterosexual couples.
  • The study's focus on patient emotional disclosure, with limited attention to caregiver disclosure, may affect relationship quality and intimacy issues.

Nursing Implications

Nurses have a role in assessing patient–partner coping during cancer treatment and referring couples to relevant resources to facilitate physical, spiritual, and psychosocial health of couples. Partner-assisted emotional disclosure in a structured supportive environment may benefit couples when patients have difficulty expressing cancer-related concerns.

Print

Portenoy, R.K., Burton, A.W., Gabrail, N., Taylor, D., & Fentanyl Pectin Nasal Spray 043 Study Group. (2010). A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain, 151(3), 617–624.

Study Purpose

To demonstrate the safety and efficacy of fentanyl-pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain

Intervention Characteristics/Basic Study Process

Consenting patients entered an open label-titration phase for determination of effective dose of FPNS. Effective dose was defined as a dose that achieved successful treatment of two breakthrough episodes. In the titration phase, if pain relief was unacceptable at 30 minutes, the patient was able to take his or her previous rescue medication. Doses were sequentially increased up to 800 mcg. Individuals who achieved an effective dose were eligible to continue in the double-blind stage. Patients received randomly assigned separate bottles, identified by number. Patients were instructed to use the bottles in the order designated. Each breakthrough episode was treated with a single dose. Pain that continued to require treatment after 30 minutes was treated with the patient’s usual rescue medication. Electronic diaries were used for data collection. Patients recorded pain intensity and pain relief at 5, 10, 15, 30, 45, and 60 minutes. Adverse events were recorded throughout the study, and visual nasal assessments were performed by the study physician at baseline and at the end of treatment. Maximum study duration was eight weeks.

Sample Characteristics

  • Seventy-three patients were in the intent-to-treat analysis.
  • Mean patient age was 53.8 years (SD = 1 year).
  • Of all patients, 46.9% were female and 53.1% were male.
  • The study included multiple tumor types. The most common were lung, breast, reticuloendothelial, and bowel.
  • All patients were receiving, on a regular basis, opioids for the treatment of pain. The most common opioids for the treatment of background pain were morphine, fentanyl, oxycodone, and methadone. Of all patients, 26% were taking multiple opioids.

Setting

Multisite (26 in the United States and 2 in other countries)

Study Design

Randomized double-blind placebo-controlled crossover study

Measurement Instruments/Methods

  • 11-point scale, to measure pain intensity
  • Five-point scale, to measure overall satisfaction
  • Five-point scale, to measure ease of use
  • Five-point scale, to rate nasal symptoms

Results

  • Thirteen patients (15.7% of those randomized) withdrew from the study because of lack of efficacy or adverse effects.
  • At 5 minutes and sustained over all other time points, the mean pain-intensity score for FPNS-treated episodes was significantly lower  (p = 0.03) than that for placebo-treated episodes. At 5 minutes, 33% of patients reporting on FPNS-treated episodes noted a drop of one point or more. At 10 minutes, 61% of patients reporting on FPNS-treated episodes noted a drop of one point or more; at 30 minutes, 73% noted a drop of one point or more.  
  • Of all FPNS-treated episodes, 90.6% did not require additional rescue medication. Of all placebo-treated episodes, 80% did not require additional rescue medication.
  • Authors noted significantly lower pain intensity (p < 0.0001) with FPNS at 60 minutes.
  • Clinical assessment of each patient's nose revealed no changes.
  • In regard to adverse events, authors noted no significant differences between treatments. 
  • In an open label extension after study conclusion, 87% of patients chose to continue use of FPNS.

Conclusions

FPNC is effective and well tolerated for treatment of breakthrough cancer pain.

Limitations

  • The study had a small sample size, with fewer than 100 patients.
  • Authors noted a high response to placebo.
  • The study period was relatively short. Whether nasal complications might occur with long-term treatment with FPNS is unclear.

Nursing Implications

FPNS is an effective approach to the management of the breakthrough pain of patients with cancer who are taking opiods for relief of background pain. FPNS can be a useful alternative in situations where clinicians want to reduce the number of oral medications. Studies of the use of nasal sprays have been relatively brief, so nurses must remain aware of the need to assess the patient’s nares and related symptoms.

Print

Portenoy, R.K., Raffaeli, W., Torres, L.M., Sitte, T., Deka, A.C., Herrera, I.G., . . . Fentanyl Nasal Spray Study 045 Investigators Group. (2010). Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients. Journal of Opioid Management, 6(5), 319–328.

Study Purpose

To evaluate the safety and tolerance of fentanyl-pectin nasal spray for cancer-related breakthrough pain

Intervention Characteristics/Basic Study Process

Patients completed an open dose-titration phase for dose determination and then entered a 16-week open label treatment phase. Patients were instructed to administer the effective dose from titration for a maximum of four episodes of breakthrough pain per day. If pain relief was inadequate after 30 minutes, patients could take the prestudy rescue medication. Investigators contacted patients at least weekly to review appropriate use of study medication, to discuss the need for dose adjustment and nasal symptoms, and to review use of rescue medication. Patients also rated nasal symptoms by using a 10-point questionnaire. A physician performed graded nasal assessments at baseline, week 8, and week 16.

Sample Characteristics

  • Authors reported that 110 patients completed the entire 16 weeks of the study.
  • Authors reported 42,227 breakthrough pain episodes in 403 patients included in the analysis.
  • Mean patient age was 53.8 years. The age range was 21–84 years.
  • Of all patients, the percentage of females was 46.9% and the percentage of males was 53.1%.
  • Authors did not report diagnosis information.
  • Of all patients, 59.8 % were on morphine; 31.5%, on fentanyl; and 14.4%, on oxycodone. These drugs were used for the treatment of  background pain.

Setting

  • Multisite
  • Outpatient
  • Multiple countries

Study Design

Open label trial

Measurement Instruments/Methods

  • Nasal-symptom questionnaire, offering a four-point assesment scale for each of the following: stuffy/blocked nose, runny nose, itching/sneezing, crusting/dryness, burning/discomfort, nose bleeding, cough, postnasal drip, sore throat, and taste disturbance
  • Measures of the neeed for rescue medication other than the study drug

Results

  • Authors reported that 110 patients completed the full 16-week extension trial.
  • Of all patients, 24.6% had treatment-related adverse events. The most common adverse events were dizziness, vomiting, constipation, and somnolence, which occurred in 3.5%–5.2% of patients.
  • Doses of fentanyl spray were 100–800 micrograms. Authors did not relate overall dose to adverse events.
  • For most patients, the results of nasal examination at the end of the study were normal. Authors observed no consistent pattern in patient-reported nasal symptoms.
  • Of the 42,227 breakthrough episodes, 94% did not require additional rescue medication to be resolved.

Conclusions

Fentanyl-pectin nasal spray for cancer-related breakthrough pain appears to be well tolerated over a use period of four months.

 

Limitations

The study has a risk of bias due to no appropriate control group.

Nursing Implications

This study showed that, over a four-month period, patients tolerated the fentanyl-pectin nasal spray well. This study suggests that long-term use is not associated with significant adverse nasal events. Fentanyl-pectin nasal spray used as specified, for the treatment of breakthrough cancer-related pain, was effective for the majority of patients. Fentanyl-pectin nasal spray is a rapidly acting treatment for breakthrough pain that can be particularly helpful to patients who have difficulty with oral intake.

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