Rugo, H.S., Seneviratne, L., Beck, J.T., Glaspy, J.A., Peguero, J.A., Pluard, T.J., . . . Litton, J.K. (2017). Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): A single-arm, phase 2 trial. Lancet Oncology, 18, 654–662.
Prevention of combination drug therapy-induced OM (stomatitis) This is the second clinical trial supported by Novartis in patients taking combination drug therapy (everolimus and exemestane).
This is the first and largest OM prevention study completed that combines therapeutic management with proactive patient engagement to reduce the incidence of OM in patients who are postmenopausal and receiving combination pill therapy(everolimus and exemestane) as treatment for hormone receptor-positive, HER2-negative metastatic breast cancer. Dexamethasone oral solution was used for two minutes, four times a day.
This is the second clinical trial performed by Novartis to eliminate dose interruption of everolimus tablets in combination therapy for women with hormone receptor-positive, HER2-negative metastatic breast cancer. The average age of the 92/86 female participants was 61 years.
This was a multi-center study in the U.S.
It was a single-arm phase 2 study
Stomatitis was graded with a composite score of CTCAE 4.0, visual analogue scale, and Normalcy of Diet Scale.
The primary endpoint of the incidence of Grade 2 or worse OM was significantly reduced by proactive oral care use of alcohol-free dexamethasone oral solution (SWISH). At 8 weeks, incidence of Grade 2 mucositis was 2% (dexamethasone) versus 33% for historical controls.
The use of dexamethasone oral solution for two minutes, four times a day, will stop OM from occurring or reduce the severity. It is used for eight weeks or longer if results are positive.
The primary limitation is it is for only one targeted group and for one target drug. The clinical trial is high strength and high quality. There could not be a control group due to the fact that the investigators did not find it ethical for patients to suffer with OM. Novartis is the manufacture of dexamethasone oral rinse and gives free eight-week supplies. There were no long-term results.
The nursing implication is to teach an oral care protocol to all patients with cancer and ask for more clinical trials for patients with other types of cancer or receiving other treatments. The SWISH trial found that a commercially available, inexpensive, well tolerated dexamethasone oral rinse is an effective intervention in the prevention of OM in women with HER2-negative metastatic breast cancer treated with everolimus.
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.
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)
Multi-site double-blind randomized-controlled trial
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.
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).
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.
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
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.
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.
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
Pilot, open-label, repeated measures, non-randomized, standard care-controlled quasi-experiment.
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:
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.
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.
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 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