Vitamin D3 for Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS)
Vitamin D is involved in maintaining the collagen-rich osteoid surface of the skeleton. Low levels of vitamin D may lead to demineralization of that surface, which may contribute to pressure and pain (Felson & Cummings, 2005; Holick, 2006, 2007; Shapiro et al., 2016). The active hormone 1a,25-dihydroxyvitamin D3 promotes muscle cell growth, which may foster better muscle function (Boonen et al., 2006; Ceglia, 2008; Shapiro et al., 2016) and decreased skeletal pain (Shapiro et al. 2016).
Mindfulness-Based Cognitive Therapy
Mindfulness-based cognitive therapy combines the principles of cognitive therapy with meditation practices to foster mindfulness (MBCT.com, n.d.). Mindfulness focused on mentally attending to an experience in a nonjudgmental way (Johannsen et al., 2016, Piet, Wurtzen, & Zachariae, 2012). Mindfulness-based cognitive therapy has been studied in several symptoms and side effects of cancer treatment, including anxiety, depression, and pain.
Cryoanalgesia
Cryoanalgesia involves the application of a cryoprobe to nerves (Ba et al., 2015; Evans, Lloyd, & Green, 1981). The cryoprobe has a bulb at its top that cools to temperatures of -50 to -80 degrees (Ba et al., 2015; Moorjani et al., 2001). It has been studied in post-surgery pain in patients with cancer.
Acupuncture and Methylcobalamin
Acupuncture is a method of producing analgesia or altering the function of a body system by inserting fine, wire-thin needles (about the diameter of a strand of hair) into acupoints along a specific meridian (meridians are channels in the body that transport energy) on the body. The needles are twirled or energized electronically or are warmed and left in place for approximately 20-30 minutes. Acupuncture has been evaluated in anxiety, CINV, dyspnea, pain, hot flashes, depression, lymphedema, sleep-wake disturbance, peripheral neuropathy, and fatigue.
Symptom Monitoring
Symptom monitoring refers to employing a focused and systematic approach to symptom monitoring in order to improve patient-reported outcomes.
Minocycline
Minocycline is a drug that has been traditionally used as an antibiotic and anti-inflammatory. It has been studied in animal models for the prevention of paclitaxel-induced neurotoxicity with some positive results; trials in humans are now underway. Until more results are known, minocycline for peripheral neuropathy should only be used in the context of a clinical trial.
Dexamethasone Mouthwash
Dexamethasone is a corticosteroid. Steroid-containing oral pastes or rinses have been used to treat aphthous ulcers (Divers & O'Shaughnessy, 2015; Nicolatou-Galitis et al., 2013; Pilotte et al., 2011; Rugo et al., 2017), also known as canker sores (Mayo Clinic, 2018), and are being studied in the treatment of cancer treatment-related mucositis.
Rambod, M., Pasyar, N., & Ramzi, M. (2018). The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. European Journal of Oncology Nursing, 33, 14–21.
Study Purpose
The purpose of the study was to evaluate the effect of zinc sulfate on the incidence and severity of mucositis in patients with leukemia undergoing chemotherapy.
Intervention Characteristics/Basic Study Process
This is a randomized, placebo-controlled, triple-blinded study conducted on patients with leukemia undergoing chemotherapy. The subjects were randomized into an experimental arm where they received zinc sulfate (50 mg) three times daily for 14 days from the first day of chemotherapy; the control group received placebo capsules three times per day. Mucositis was measured by the Oral Mucositis Index and World Health Organization mucositis scale on the 4th, 7th, and 14th day after chemotherapy.
Sample Characteristics
- N = 69
- MEAN AGE: 36.725 years
- MALES: 57%
- FEMALES: 43%
- CURRENT TREATMENT: Chemotherapy
- KEY DISEASE CHARACTERISTICS: AML, ALL, CML
Setting
SITE: Multi-site
SETTING TYPE: Not specified
LOCATION: Nemaze Hospitals affiliated to SUMS, Shiraz, Iran
Phase of Care and Clinical Applications
- PHASE OF CARE: Active anti-tumor treatment
- APPLICATIONS: Palliative care
Study Design
This is a randomized clinical trial and placebo-controlled study for patients undergoing chemotherapy for leukemia. Patients were randomly assigned to receive either zinc sulfate or placebo.
Measurement Instruments/Methods
- IBM SPSS Statistics, version 20
- Kolmogorov-Smirnov test
- Independent t test and chi-square test
- Repeated measures analysis of variance (RM-ANOVA)
Results
There is significant difference in the incidence of mucositis during the 14 days of the study, 9 patients (25%) in the experimental group (zinc sulfate) and 19 (54%) in the control group (placebo) showed incidence of mucositis was 2.1 times higher in the control group. Onset of mucositis occurred on days 5.83 (SD = 3.37) (zinc sulfate) and 4.58 (SD = 2.47) (placebo), t test showed no difference between these two groups regarding the onset of mucositis (t = 0.95, p = 34). There is no confirmation of mucositis occurring later in the zinc sulfate group in comparison to the control group. The severity of mucositis was milder in the experimental group compared to the control group on 4th, 7th, and 14th day. RM-ANOVA indicated significant difference between mean score objective evaluation of mucositis the two groups (F = 7.83, p = 0.07). Results also showed significant difference between the two groups' mean score of subjective evaluation of mucositis (F = 5.79, p = 0.01)
Conclusions
The results of the study show that zinc sulfate is helpful in preventing mucositis in patients with leukemia undergoing chemotherapy. The current study does not support any significant difference between the two group in delaying onset of mucositis. The severity of mucositis was milder in the zinc sulfate group in comparison to the control group.
Limitations
- Small sample (< 100)
- Risk of bias (sample characteristics)
- Findings not generalizable
- Other limitations/explanation: Length of the study, evaluation of mucositis for a longer time
Nursing Implications
Using zinc sulfate at the dose of 50 mg three times per day for 14 days helped to prevent and decrease the severity of mucositis in the leukemia population undergoing chemotherapy. This along with standard of care oral hygiene could be an effective treatment to prevent and decrease the severity of mucositis. Additional research is needed.
Jiang, C., Wang, H., Xia, C., Dong, Q., Chen, E., Qiu, Y., . . . Chen, T. (2018). A randomized, double-blind, placebo-controlled trial of probiotics to reduce the severity of oral mucositis induced by chemoradiotherapy for patients with nasopharyngeal carcinoma. Cancer, 125, 1081-1090.
Study Purpose
The purpose was to evaluate a probiotic combination on the severity of oral mucositis in patients with nasopharyngeal cancer who are undergoing concurrent chemotherapy and radiation therapy.
Intervention Characteristics/Basic Study Process
Probiotic combination (Bifidobacterium longum, Lactobacillus lactis, and Enterococcus faecium) three capsules BID from the beginning of treatment to end of treatment, up to 7 weeks.
Sample Characteristics
- N = 99 (2:1 randomization, n = 64 in probiotic group and n = 35 in placebo group)
- MEAN AGE: 50.4 years in treatment group and 51.69 years in placebo group
- MALES: N = 58 (n = 21 [60%] in treatment group, n = 37 (64%] in control group)
- FEMALES: N = 35 (n = 14 [40%] in treatment group, n = 21 [36%] in control group)
- CURRENT TREATMENT: Combination radiation therapy and chemotherapy
- KEY DISEASE CHARACTERISTICS: Nasopharyngeal cancer
- OTHER KEY SAMPLE CHARACTERISTICS: n/a
Setting
- SITE: Single site
- SETTING TYPE: Outpatient
- LOCATION: China
Phase of Care and Clinical Applications
PHASE OF CARE: Active anti-tumor treatment
Study Design
RCT, double-blind, placebo controlled
Measurement Instruments/Methods
Mucositis was measured with the CTCAE, version 4.0, by two senior radiation oncologists daily. Routine blood analysis, biochemical analysis, and lymphocyte immunity were measured before and after treatment.
Results
Patients in the intervention group showed a significant reduction in the severity of OM. The incidences of grade 0, 1, 2, and 3 OM in the placebo group and the probiotic combination group were 0% and 12%, 0% and 55%, 54% and 17%, and 46% and 16%, respectively. Additional genomic and biochemical analysis results reported.
Conclusions
The probiotic combination significantly reduced oral mucositis. Blood test results found that this reduction may be due to improvements in immunity. The optimal dose and schedule still needs to be explored.
Nursing Implications
Probiotics have the potential to improve outcomes related to oral mucositis in patients receiving combination chemotherapy and radiotherapy for nasopharyngeal cancer. Additional research is needed to identify the ideal dose and schedule for this treatment.