Oral mucositis among solid tumor cancer patients on chemotherapeutic regimens at Uganda cancer institute: experiences, incidence, risk factors, and effect of cryo-therapy

Abstract

Background: Cancer chemotherapy causes oral mucositis (OM) that can be extremely painful, disrupting eating, talking and other daily activities. Sometimes OM can be so severe leading to interruption of cancer therapy. Interventions that reduce OM led to improvement in patients’ treatment compliance, outcomes and quality of life. However, to capture the incidence and monitor the effects of any intervention, a suitable measurement tool for OM must be chosen from the many available. The tool must add minimal burden to the patients, caregivers and clinicians Patients’ perspectives on diseases and side effects of treatment have increasingly taken center stage. Hence mucositis is no exception to this trend. Therefore, it is imperative to capture what oral mucositis means to our patient population. To get a good insight into what patients who suffered from oral mucositis went through, I captured their experiences through a qualitative approach. Objective: Using a patient reported outcomes measures, I set out to determine the experiences, incidence, risk factors for OM and how effective cryo-therapy can be in preventing OM and its resultant complications among patients with solid tumours’ in Uganda Cancer Institute. Methods: This was a multiple methods study that was divided into 4 sub studies. Sub-study I was a validation design meant to translate and validate the Mucositis Daily Questionnaire Mouth and Throat Soreness OMDQ MTS into Luganda. A qualitative approach was used to capture patients’ experiences with OM. In this sub study II,. Data were collected through separate in-depth interviews (IDIs) and focus group discussions (FGDs) based on semi structured qualitative interviews of 13 cancer patients and 5 FGDs. For the tool validation sub study, validation of the OM measurement tool was done using bilingual patients who were receiving chemotherapy at Uganda Cancer Institute (UCI) and had experienced some oral discomfort following treatment. They were asked to complete Oral Mucositis Daily Questionnaire Mouth and Throat Soreness OMDQ MTS Luganda followed by the English version on the same visit. The tools had different order of items and were administered to the participants at least two hours apart. Using the validated Mouth and Throat Soreness related questions of the oral mucositis (OMDQ MTS) questionnaire, oral mucositis was prospectively evaluated among patients undergoing chemotherapy for solid tumors at the UCI. The participants also had specific visits to UCI for clinicians assess oral mucositis. This sub-study III captured the incidence and risk factors of oral mucositis among our patient population.In the quasi-experimental sub study IV, there were two groups each of 100 participants with solid tumors and residing within a 20 Km radius to the Uganda Cancer Institute. The control group had the standard of care as per UCI protocols on other hand, the intervention group had the same but additionally received cryotherapy before, during, and after chemotherapy. Occurrence of moderate and severe mucositis was evaluated for all participants who returned for the clinical evaluation visits and filled the self-administered oral mucositis assessment tool. The study participants were examined clinically: before chemotherapy and after day 3,7,10 and 14 following the initial dose of their treatments using the clinician evaluated the severity of mucositis based on scores 0 to 4 as described by World Health Organisation (WHO). In addition, patients completed an English or Luganda version of the self-assessment OM Daily Questionnaire Mouth and Throat Soreness (OMDQ MTS) that allowed them to grade their degree of oral mucositis. The relationships between OMDQ MTS and clinical data were appraised with Spearman Rank correlation tests. Comparison between the two groups was done using either Chi-square tests or Mann-Whitney U-test (non-parametric t-test).Results: From the qualitative sub study, most of the participants felt they needed more information and counselling before, during and after chemotherapy. Fifty purposively sampled participants accepted to take part by completing both versions of OMDQ MTS questionnaire. All item mean score differences between the two versions were less than ±0.25. The Cronbach’s α for the Luganda and English versions were 0.78 and 0.86, respectively, based on standardized items while the Guttman’s lambada 2 and 3 where 0.89 and 0.79, respectively.The results demonstrated that patient assessment of mucositis was possible in a Ugandan setting at a 76% full compliance rate and therefore it would be worth adopting. Up to 30% of the patients, reported moderate to severe mucositis though the value was lower compared to what was assessed by the clinicians. There was no statistically significant difference between patients above 45 years and those below, those with and without a history of tobacco use in terms of incidence of moderate to severe OM (p=0.37 and p=0.67, respectively). Chemotherapy regimens that included 5-FU were significantly associated with severe to moderate OM (p=0.04). Neither pre-chemotherapeutic hemoglobin nor neutrophil levels were associated with OM (p=0.53 and p=0.74, respectively). The weight and surface area of the patients were also not significantly associated with increased occurrence of moderate to severe OM (p=0.39 p= 0.15, respectively). Likewise, the oral hygiene status of the patients did not significantly affect the incidence of moderate to severe OM in the study population (p=0.09). Only cancer type was statistically significantly different between the control and intervention groups (χ2=31.09, df =18, p=0.03). Twenty percent (n=19/95), while 8.2% (n=7/85) in the control and intervention group, respectively, developed moderate to severe mucositis (Mantel-Cox and Generalized Wilcoxon p= 0.026 and p=0.0312, respectively).Conclusions: Glaring improvements that are needed included information and counselling before, during and post chemotherapy. A translated Luganda version of OMDQ MTS was reliable and easy to understand. Therefore, in our local setting, self-reported OMDQ MTS can be useful to evaluate mucositis on a daily basis among adults without the need for costly frequent clinic visits. The use of cryotherapy in the present study setting and probably in many sub-Saharan African countries is a feasible and affordable approach to the prevention and control of chemotherapy induced oral mucositis.