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  • Corticosteroids, Systemic

Hershman, D.L., Unger, J.M., Crew, K.D., Till, C., Greenlee, H., Minasian, L.M., . . . Albain, K.S. (2018). Two-year trends of taxane-induced neuropathy in women enrolled in a randomized trial of acetyl-l-carnitine (SWOG S0715). Journal of the National Cancer Institute, 110, 669–676.

Study Purpose

To investigate the clinical phenotype of CIPN and longitudinal patterns of CIPN over 24 month period in patients on the SWOG S0715 trial (double-blind RCT of stage I-III patients with breast cancer who received an adjuvant taxane-based regimen and compared CIPN between those in the treatment group - acetyl-L-carnitine (ALC) versus the placebo control group x 24 weeks)

Intervention Characteristics/Basic Study Process

  • SWOG S0715 post-trial statistical analysis evaluating two-year trends for effect of ALC on peripheral neuropathy using baseline demographics factors and longitudinal data (24 months) of neurotoxicity scores (NTX) scores collected at study baseline, 12, 24, 36, 52, and 104 weeks (see SWOG S0715 trial below). Neurotoxicity scores were analyzed using linear mixed models. Linear regression analyzed individual time points. Baseline neurotoxicity scores and stratification factors were considered in the regression analysis.
  • SWOG S0715 trial: A double-blind RCT of women older than age 18 years and with a diagnosis of stage I-III breast cancer receiving an adjuvant taxane-based chemotherapy regimen with a stratified random assignment (by taxane-based chemotherapy regimen and age younger than 60 or older than 60) to either the study drug group: Acetyl-L-carnitine (ALC) 3,000 mg per day divided into six tablets (1,000 mg three times a day) versus control group: matching placebo cellulose 3,600 mg per day divided into six tablets,(1,200 mg three times a day). Treatment with either ALC versus placebo control started at the beginning of chemotherapy and continued daily for a duration of 24 weeks. Peripheral neuropathy was measured at baseline and at 12, 24, 36, 52, and 104 weeks. 
  • Taxane-based chemotherapy regimens: weekly paclitaxel 80 mg/m2 for 12 cycles, biweekly paclitaxel 175 mg/m2 for 4 or 6 cycles, every-three-week docetaxel 75 mg/m2 for 4 or 6 cycles

Sample Characteristics

  • N = 409 at baseline; 327 at two years   
  • MEAN AGE: Combined, 52.5 years; ALC, 53.3; placebo, 51.9
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage I-III breast cancer starting adjuvant treatment with a taxane-based regimen
  • OTHER KEY SAMPLE CHARACTERISTICS: Age, race, ethnicity, weight, prior mastectomy, planned treatment regimen, performance status, and receipt of G-CSF; patients with diabetes, prior CIPN, and kidney disease, and those taking vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline, duloxetine, or other potentially CIPN-treating supplements were excluded.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Unknown

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Multi-site double-blind randomized-controlled trial

Measurement Instruments/Methods

Peripheral neuropathy measured by the 11-item neurotoxicity section of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX). A lower score indicates worse CIPN and more than 10% (or 5 points) is considered clinically significant. Sensitivity analysis done to evaluate a 10-point decrease in the FACT-NTX scores from baseline; other measurements were secondary outcomes: FACT-Taxane Trial Outcome Index; fatigue measured by 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. All patient measurements taken at baseline and weeks 12, 24, 36, 52, and 104.

Results

Linear mixed model results showed the average difference of NTX between the ALC group and placebo control group was statistically significant (p = 0.01) with worsened CIPN in the ALC group, at 24 weeks (p = 0.02); 36 weeks (p = 0.04); and 52 weeks (p = 0.02) compared to the placebo control group. Functional status (FACT TOI) scores worsened at weeks 24 (p = 0.04) and week 52 (p = 0.05), but was not significantly different at week 104 (p = 0.09). No difference between ALC group and placebo control group for FACIT-Fatigue. No differences observed between groups for medications taken to treat CIPN. At one year, women aged 60 or older had a higher risk of worsening peripheral neuropathy compared with women 60 years or younger at one year (OR = 1.74, p = 0.02) and at two years (OR = 1.67, p = 0.04).

Conclusions

In women receiving a taxane-based chemotherapy, 24 weeks of ALC therapy to reduce symptoms of CIPN caused a statistically significant worsening of short- and long-term CIPN over two years compared to placebo. Age was a risk factor for long-term CIPN. Women 60 years or older were 1.5 times more likely to have clinically significant long-term CIPN.

Limitations

Exploratory statistical plots showed a non-linear relationship requiring statistical transformation procedures; no quantifiable neuro-diagnostic tests, such as balance/nerve conduction/TNS; no differentiation between sensory, motor, or autonomic neuropathy; no reports of comorbidities developing over course of study; no cumulative taxane dose or number of cycles received

Nursing Implications

Acetyl-L-carnitine (ALC) has previously been identified as a potential pharmacotherapeutic option for CIPN; however, based on the study results, ALC is not recommended as therapy for CIPN because it can cause harm in worsening CIPN. This study points to the necessity for further research into the mechanisms of CIPN, toxicities, and preventive interventions.

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Izgu, N., Ozdemir, L., & Bugdayci Basal, F. (2017). Effect of aromatherapy massage on chemotherapy-induced peripheral neuropathic pain and fatigue in patients receiving oxaliplatin: An open label quasi-randomized controlled pilot study. Cancer Nursing, 42, 139-147.

Study Purpose

To explore the effects of aromatherapy hand/foot massage on chemotherapy-induced peripheral neuropathy (CIPN), pain incidence and severity, and fatigue severity, compared to standard care in GI cancer survivors who are actively receiving oxaliplatin

Intervention Characteristics/Basic Study Process

  • Intervention: Aromatherapy hand/foot massage: ~40 minute sessions (10 minutes each hand/foot), 3 times per week, for 6 weeks (1-2 rest days between massages). Techniques included effleurage, light friction, and petrissage.
    •   Interventionist: the PI “qualified in massage therapy”
    •   Setting: Patients’ homes
    •   Essential oils: Chamomile, peppermint, and rosemary 1:1:1 blend in coconut oil made q72 hours ~2 ml applied to each hand/foot.
  • Control condition: Standard care

Sample Characteristics

  • N = 46   
  • AGE: 55.8 years (SD = 8.49) 
  • MALES: 59%  
  • FEMALES: 41%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Actively receiving FOLFOX6; primarily patients with colon cancer; stage of cancer unknown.
  • OTHER KEY SAMPLE CHARACTERISTICS: Paresthesias rated ≥ 1 on NRS (range = 1-7); 2 (4%) patients had neuropathic pain at baseline per the DN4 cut-off; similar groups at baseline (including CIPN levels and dose/cycle of oxaliplatin received). Excluded patients with brain metastasis and preexisting neuropathy; whose oxaliplatin dose was reduced; and who were taking medication for neuropathy. 63% of eligible participants were recruited; 87% completed study. Two control group participants discontinued study due to fear of getting CIPN. 15% had received chemotherapy prior to their current FOLFOX regimen.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Ankara, Turkey: two university/research oncology hospitals

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Pilot, open-label, repeated measures, non-randomized, standard care-controlled quasi-experiment.

Measurement Instruments/Methods

  • Douleur Neuropathique 4 Questions (DN4): assessed patient self-reported neuropathic pain degree and presence via interview of neuropathic pain characteristics and association of pain with numbness, tingling, and itching; and clinical examination of painful area (hypoesthesia, pinprick, and allodynia). 
  • Patient-report surveys: “Patient Questionnaire” (CIPN symptom location, aggravating factors, timing of peak severity, demographic, and clinical characteristics); 0-10 NRS (Current painful paresthesia severity-no pain to worst possible pain); Piper Fatigue Scale (PFS)
    • Timepoints of measurement: 
      • Baseline (before starting intervention)
      • At chemotherapy visits
        • ~mid-study (at 2 and 4 weeks)
        • ~post-intervention (6 weeks)
        • ~2 weeks postintervention completion (8 weeks)
    • Assessor: PI

Results

  • DN4: significantly lower CIPN neuropathic pain incidence in the intervention group (IG) than the control group (CG) at 6 weeks (p = 0.046), and severity at 4 and 6 weeks (p range = 0.006-0.027). 
  • 0-10 NRS: significantly lower painful paresthesia severity after just one week in the IG than the CG (p ≤ 0.016). Median NRS scores remained a 3-4 at each follow-up (weeks 2-8), which was lower than the baseline score of 4.3, in the IG; but the NRS scores steadily increased from 4 at baseline to 5.5 at 8 weeks in the CG.
    • These effects (DN4 and NRS) did not last up to the 8-week timepoint.
  • Piper Fatigue Scale (PFS): significantly lower fatigue levels at the 8-week timepoint in the IG than the CG (p = 0.036).

Conclusions

Aromatherapy hand/foot massage, using chamomile, rosemary, and peppermint oil, given 3 times per week for 40 minutes (10 minutes each hand/foot) during FOLFOX treatment may: 

  • Transiently reduce the incidence and severity of CIPN neuropathic pain after 6 weeks, compared to standard care
  • Help to treat or prevent the worsening of CIPN pain, as early as after one week of intervention; and fatigue long-term (2 weeks post a 6-week period of aromatherapy/massage treatment)

However, more rigorous RCTs with blinded assessors, utilizing larger sample sizes, are needed to evaluate the preventative and treatment effectiveness, necessary dosage, physiological mechanisms, and long-term effects of aromatherapy hand/foot massage on FOLFOX-induced CIPN pain.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition) 
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Selective outcomes reporting
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: Participants were recommended for the study by the med-oncs (sample bias); named as randomized, but procedures described a stratified but not randomized approach. PI was the massage therapist (unclear certification for massage therapy) and assessor of the primary outcome. Therapeutic interaction during massage could have contributed toward the intervention efficacy. Unspecified baseline assessment timing relative to chemotherapy infusion. Missing values were filled-in using the last-observation-carried-forward method. Mentioned a “primary education program” on page 5 with a very low completion rate, but this program was not mentioned elsewhere. No report of “Patient Questionnaire” outcomes. Measures were highly subjective. Intervention requires a certified aromatherapy/massage therapist able to travel to give 3 home visits of 40 minutes each. No control for potential moderators, such as mood/psychological well-being/coping.

Nursing Implications

Aromatherapy hand/foot massage during oxaliplatin treatment may be a safe and promising nonpharmacologic therapy for CIPN pain and fatigue. Further investigation of this therapy is warranted.

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Kyphoplasty

Kyphoplasty involves the use of a balloon to help restore the shape of a damaged vertebra and the injection of cement. The procedure can re-establish the vertebra’s height and may relieve pain. (Johns Hopkins Medicine, 2019).

Johns Hopkins Medicine. (2019). Health: Kyphoplasty. Retrieved from https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/ky…

Doxycycline Mouthwash

Doxycycline is a tetracycline antibiotic that prevents the growth and spread of bacteria. It is used to treat a variety of infections; for example, pneumonia; infections spread by ticks, infected animals, or contaminated water or food; anthrax; and plague. Doxycycline is used with other medications to treat acne (American Society of Health-System Pharmacists, 2019).

American Society of Health-System Pharmacists. (2019). Doxycycline. Retrieved from https://medlineplus.gov/druginfo/meds/a682063.html

Category

Episode 63: Immunotherapy Communication Challenges

  • Immunotherapy;
  • Communication;
  • Get CNE;
  • Learn Cancer Care

Yun, Y.H., Kim, Y.A., Lee, M.K., Sim, J.A., Nam, B.H., Kim, S., . . . Park, S. (2017). A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors. BMC Cancer, 17, 298-017-3290-9.

Study Purpose

To assess if cancer survivors’ physical activity, dietary habits, and distress management would benefit from a Leadership and Coaching for Health (LEACH) program

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to the LEACH Program (LP) intervention group or the usual care (UC) control group. 

LP group received a one-hour health education workshop (topics covered included physical activity, dietary habits, and distress management), a three-hour leadership workshop, and individual telephone coaching for 24 weeks. A total of 16 tele-coaching sessions were held: 30 minutes per week for 12 sessions, 30 minutes per 2 weeks for 2 sessions, and 30 minutes per month for 2 sessions. 
The UC group was asked to continue their usual care and received a health education booklet on dietary habits, physical activity, and distress management, as well as a four-hour lecture on physical activity, dietary habits, distress management, and a screening for a second cancer.  

Patient evaluations took place at baseline, 3 months, 6 months, and 12 months.

Sample Characteristics

  • N = 206 cancer survivors
  • AGE: 20 years or older
  • MALES: 42 (20.39%)  
  • FEMALES: 164 (79.61%)
  • CURRENT TREATMENT: Immunotherapy
  • KEY DISEASE CHARACTERISTICS: Cancer survivors who completed primary cancer treatment within the last 24 months for breast, stomach, colon (other than rectal), and lung cancer within 18 months of completion of primary treatment. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Platelet count of greater than or equal to 100,000/mm3, have serum hemoglobin of greater than or equal to 10 g/dl, and have not already met two or more behavioral goals aimed for in the study.

Setting

  • SITE: Multi-site
  • SETTING TYPE: Not specified

Phase of Care and Clinical Applications

PHASE OF CARE: Survivorship

Study Design

12 month randomized control trial, patients evaluated at 0, 3, 6, and 12 months.

Measurement Instruments/Methods

Cancer registry from 10 South Korean teaching hospitals; questionnaire based on the “Rules for National Cancer Prevention: Dietary Practice Guideline” and the Korean National Health and Nutrition Examination Survey data; METs (kcal/kg per week) for physical activity; Post-Traumatic Growth Inventory; Seven Habit Profile; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Diener’s Satisfaction With Life Scale; Hospital Anxiety and Depression Scale; Impact of Events Scale-Revised; Medical Outcomes Study Social Support Survey; Ten Rules for Highly Effective Health Behavior

Results

There was no significant difference between the two groups; UC and LP for primary or secondary outcomes.

For primary outcome, UC and LP groups did not significantly differ in intake of fruit and vegetable intake, and physical activity, but differed at 12 months in post-traumatic positive growth (p = 0.065).

For secondary outcomes, from baseline to 3 months, the LP group showed a  greater decrease in the anxiety score (p = 0.025), a greater increase in social functioning score  (p = 0.018), and a greater decrease in appetite loss (p = 0.048) and financial difficulties (p = 0.036).

From baseline to 12 months, the LP group showed a decrease in fatigue (p = 0.065) and an increase in number of 10 Rules for Highly Effective Health Behavior adhered to by patients. Patient subjective cancer-induced stress in response to specific traumatic events, scored between UC and LP groups, were marginally significant from baseline to 12 months (p = 0.068).
 

Conclusions

Participants’ primary behaviors of physical activity and dietary habits did not change due to this program. Participants’ management of their anxiety, social functioning, and symptoms did somewhat improve. 

Limitations

  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Dropout rate of 42 before baseline with an additional 55 by the end of the study. At 12 months, the final number of participants was 151, down from 248 at randomization.

Nursing Implications

Long-term cancer survivors partnering with healthcare professionals may be helpful in reducing distress and anxiety in cancer survivors who recently completed cancer treatment. Increased education and training is needed for the long-term cancer survivors to coach.

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Sun, F.K., Hung, C.M., Yao, Y., Lu, C.Y., & Chiang, C.Y. (2017). The effects of muscle relaxation and therapeutic walking on depression, suicidal ideation, and quality of life in breast cancer patients receiving chemotherapy. Cancer Nursing, 40, E39-E48.

Study Purpose

To measure the effects of muscle relaxation and therapeutic walking on depression, suicidal ideation, and quality of life in patients with breast cancer receiving chemotherapy

Intervention Characteristics/Basic Study Process

Two interventions. (a) muscle relaxation techniques using CD at least two times daily for 12 weeks, three visits in the hospital by the researcher who trained them in the practice of the MRT, and understood the techniques. (b) Therapeutic walking with a pedometer provided to patients. Walking technique and pedometer use taught by researcher. Asked to walk 90-120 minutes per week or three times per week for at least 30 minutes per session. Record steps, walking time, strength for 12 weeks. Control group: no intervention.

Sample Characteristics

  • N = 87   
  • MEAN AGE: 54.1 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Half had stage II breast cancer, half had been diagnosed for more than 1 year and had finished their chemotherapy. Most were not in relapse, had no psychiatric history, and were not using medication for depression.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Surgical outpatient, surgical unit hospital in south Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Randomized control study

Measurement Instruments/Methods

  • Center for Epidemiological Studies Depression Scale
  • Beck Scale for Suicidal Ideation
  • World Health Organization Questionnaire on Quality of Life

Results

The results showed no significant difference in any outcome variable in the pretest. The results of the post-test indicated that the two groups scored significantly differently only on the Center for Epidemiological Studies Depression Scale (U = 638, p < 0.05). The patients with breast cancer who participated in the three-month muscle relaxation and therapeutic walking interventions had a lower level of depression  (RE = 37) than those who did not (RC = 51.16).

Conclusions

No difference in groups on pretesting (initially).  After intervention, the group with the intervention scored significantly differently only on the depression scale.

Limitations

  • Small sample (< 100)
  • Intervention expensive, impractical, or training needs

Nursing Implications

Nursing staff could teach and encourage the use of muscle relaxation techniques, as well as therapeutic walking to reduce depressive symptoms for patients undergoing chemotherapy.

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Cheng, K.K.F., Lim, Y.T.E., Koh, Z.M., & Tam, W.W.S. (2017). Home-based multidimensional survivorship programmes for breast cancer survivors. Cochrane Database of Systematic Reviews, 8, CD011152.

Purpose

  • STUDY PURPOSE: To determine if home-based, multidimensional survivorship (HBMS) programs help maintain or improve breast cancer survivors’ quality of life
  • TYPE OF STUDY: Systematic review and meta-analysis

Search Strategy

  • DATABASES USED: Cochrane Breast Cancer Specialised Register, CENTRAL, PubMed, Embase, CINAHL Plus, PsycINFO, Web of Science, World Health Organization’s International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov
  • YEARS INCLUDED: (Overall for all databases) Final search results were 2006-2016
  • INCLUSION CRITERIA: RCTs and quasi-RCTs using articles that appeared in peer-reviewed journal articles published in English, interventions with more than one of these components: educational, physical, and psychological interventions that were home-based, including delivery in-person, through telephone calls, Internet or multi-media, a validated instrument used to assess health related quality of life as an outcome
  • EXCLUSION CRITERIA: Studies without a control group, women with stage IV breast cancer, lack of home-based component of intervention, lack of trained personnel or healthcare professional delivering intervention, lack of separate breast cancer survivors analysis, lack of quality-of-life assessments, lack of description of intervention

Literature Evaluated

  • TOTAL REFERENCES RETRIEVED: 29,198
  • EVALUATION METHOD AND COMMENTS ON LITERATURE USED: 29,198 studies were originally found by electronic search, and 25,907 were left after duplication removal. 25,740 articles were removed after exclusion and inclusion criteria, leaving 174 articles for full-text assessment. Further screening using inclusion and exclusion left 26 studies; 25 journal articles and 1 dissertation (8 ongoing studies) (1998-2015).

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED: 26
  • TOTAL PATIENTS INCLUDED IN REVIEW: 2,272
  • KEY SAMPLE CHARACTERISTICS: Women aged 18 years and older with a breast cancer diagnosis between stages 0-III and within 10 years of the completion of primary cancer treatment (surgery, chemotherapy, radiation therapy).

Phase of Care and Clinical Applications

PHASE OF CARE: Survivorship

Results

  • Home-based multidimensional survivorship (HBMS) programs positively improve quality of life short-term, as measured by FACT-B and EORTC-C30 questionnaires (FACT-B: mean difference (MD) = 4.55, 95% CI [2.33, 6.78], 7 studies, 764 participants; EORTC: MD = 4.38, 95% CI [0.11, 8.64], 6 studies, 299 participants)
  • HBMS may reduce anxiety, fatigue, and insomnia as measured by HADS, BFI, and ISI. HBMS programs may decrease anxiety (MD of Hospital Anxiety and Depression Scale (HADS) = -1.01, 95% CI [-1.94, -0.08], 5 studies, 253 participants). There was no evidence of improvements in depression after HBMS (MD of HADS = -1.36, 95% CI [-2.94, 0.22], 4 studies, 213 participants). HBMS programs may also decrease fatigue (MD = -1.11, 95% CI [-1.78, -0.45], 3 studies, 127 participants) and insomnia (MD = -1.81, 95% CI [-3.34, -0.27], 3 studies, 185 participants)
  • Quality of life with educational, psychological, or physical intervention components showed no difference in improvement. 
  • Improvement of physical, emotional, and functional quality of life was most effective with group-based intervention.

Conclusions

HBMS programs in breast cancer survivors were found to provide beneficial short-term improvement of breast cancer-specific quality of life and global quality of life. Also, immediately after the intervention, a reduction in anxiety, fatigue, and insomnia was assessed.

Limitations

  • Mostly low-quality/high-risk of bias studies
  • High heterogeneity
  • Low sample sizes
  • Sample bias

Nursing Implications

Group-based intervention was shown to be the most effective mode of delivery toward improving physical, emotional, and functional quality of life

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