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«The Experience of a Sore Mouth and Associated Symptoms in Patients With Cancer Receiving Outpatient Chemotherapy By: Brown, Carlton G. PhD, RN, AOCN; ...»

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The Experience of a Sore Mouth and Associated Symptoms in Patients With Cancer Receiving

Outpatient Chemotherapy

By: Brown, Carlton G. PhD, RN, AOCN; McGuire, Deborah B. PhD, RN, FAAN; Peterson, Douglas E. PhD,

DMD; Beck, Susan L. PhD, APRN, FAAN; Dudley, William N. PhD; Mooney, Kathleen H. PhD, RN, AOCN,


Brown, C., McGuire, D., Peterson, D., Beck, S., Dudley, W., & Mooney, K. (2009). The experience of a sore

mouth and associated symptoms in patients with cancer receiving outpatient chemotherapy. Cancer Nursing, 32(4), 259-270. DOI: 10.1097/NCC.0b013e3181a38fc3

Made available courtesy of LIPPINCOTT WILLIAMS & WILKINS:

http://journals.lww.com/cancernursingonline/pages/default.aspx ***Reprinted with permission. No further reproduction is authorized without written permission from LIPPINCOTT WILLIAMS & WILKINS. This version of the document is not the version of record.

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This study aimed to describe sore mouth (SM) severity and distress, associated symptoms, and consequences in cancer chemotherapy outpatients. Secondary analysis was used in this study. A total of 223 patients in 4 treatment centers participated in the study. Data from an intervention study using a computer-based telephone communication system to assess patients' daily symptom experience were analyzed to obtain highest, average, and lowest ratings of severity and distress for SM, fatigue, trouble sleeping, feeling down/blue, and feeling anxious. Consequence data included oral intake, time spent lying down, ability to work, and daily activity.

Approximately 51% reported SM, with a mean highest, average, and lowest severity score of 3.1 in cycle 2 and

3.09 in cycle 3. Sore mouth severity was correlated with severity of fatigue, feeling down/blue, feeling anxious, and trouble sleeping. Sore mouth distress was correlated with the same symptoms. Sore mouth severity was correlated with the number of 8-oz glasses of liquid consumed, effect on daily activity, time spent lying down, but not with ability to work. Half of patients experienced SM, which was associated with several other symptoms and led to specific consequences. Understanding the complex symptom experience of patients with SM, including consequences, will assist nurses in developing more comprehensive clinical assessments and interventions. In addition, the association of multiple symptoms with SM will provide a foundation for further research investigation in oral mucositis.


Oral mucositis (OM) can be a debilitating condition associated with cancer therapy. Comprised of the hallmark signs of erythema and ulceration, OM is typically accompanied by acute oral pain, often expressed by patients as a "sore mouth" (SM), which is due to damage of the affected oral mucosa.1,2 Patients may also experience a variety of physical sequelae such as difficulty swallowing, difficulty speaking, decreased oral intake, mood disturbances (including anxiety and depression), sleep disturbances, and fatigue.3 Significant nutritional shortfalls are also common and can be manifested as anorexia, dehydration, malnutrition, and weight loss.

Although OM is best evaluated through a systematic oral examination, there is clearly a subjective component to the experience.4 This subjective component is an SM, reported by patients as altered sensations that can be measured both by intensity and distress. The use of such self-reports is the best way to evaluate the experience when patients are not available for an oral examination, as typically occurs in patients receiving chemotherapy in the outpatient setting. This report applies Armstrong's Symptoms Experience Model (SEM)5 to examine the experience of SM in relation to antecedents, co-occurring self-reported symptoms, and consequences of SM as self-reported by patients receiving chemotherapy on a daily basis (Figure 1).

Figure 1 Armstrong's Symptom Experience Model 5 adapted for the purpose of this study.


This study was designed to describe the experience of SM, with a focus on severity and distress, associated symptoms, and consequences in patients with cancer receiving cycles 2 and 3 of outpatient chemotherapy. The data were obtained from a larger intervention study in which patients reported their SMs and other symptoms daily (see Methods below).

The specific aims were to (1) evaluate demographic and clinical factors associated with the occurrence of SM, (2) examine associations among SM severity and SM distress and the severity and distress of 4 self-reported symptoms (feeling down/blue, feeling anxious, trouble sleeping, and fatigue) over cycles 2and 3 of chemotherapy, and (3) explore the consequences of the experience of SM.


The incidence, duration, and severity of OM are often dose limiting, and patterns of mucositis vary.6 Oral mucositis can influence survival, including potential for remission and cure rates. Unfortunately, there are few effective interventions to prevent or treat OM at this time.7,8 Approximately 1.2 million American patients receive antineoplastic treatment each year as a treatment for cancer,7 and approximately 400,000 will develop OM as a consequence.9 The incidence of OM varies related to the respective treatment; for example, approximately 75% of patients undergoing intensive high-dose chemotherapy during hematopoietic stem cell transplantation (HSCT) experience OM.2,10 Nearly 40% of all patients receiving chemotherapy develop OM, and of these, about 50% experience lesions so severe that their chemotherapy regimen must be modified.11 Oral mucositis has been studied extensively for more than 20 years, usually in hospitalized patients receiving high-dose chemotherapy (eg, before stem cell transplantation). There has been only limited research on OM in patients receiving outpatient chemotherapy.1 This research has been limited by methods to assess OM when patients are not available for an oral examination. In the United States, the overwhelming majority of patients are receiving chemotherapy on an outpatient basis, estimated at approximately 90% in outpatient settings nationwide.12 Considering these numbers, the experience of OM in the outpatient population warrants careful attention, specifically the occurrence of OM. Although the occurrence of OM has been described in the literature retrospectively,13 to date, there has been no research that prospectively describes OM in the literature using reliable and valid instruments for measurement.

Symptoms Related to SM

Patients receiving cancer treatment typically experience and require treatment of multiple symptoms simultaneously.14,15 Until recently, symptom research has usually focused on a single symptom such as pain, nausea, constipation, or anxiety.16 Although this approach has led to advances in the understanding and management of a particular symptom, patients rarely present with just 1 symptom.14,17 Studies have demonstrated relationships among the symptoms of pain, anxiety, fatigue, depression, and insomnia in patients with cancer, but only a limited number of studies have investigated symptoms associated with OM 2,16,18-21 and none have investigated symptoms associated with SM. Thus, further investigation is warranted because understanding the complex symptom experience of patients with SM will lead to enhanced knowledge on this experience and identification of directions for prospective research and OM in chemotherapy outpatients and potential new avenues for clinical interventions. The current study addresses the association of symptoms in a given chemotherapy population, and such descriptive work is the foundation of future, more targeted work in symptom management.

Epidemiology and Scope

Mucositis is one of the most common problems seen in patients treated with high-dose chemotherapy and/or head and neck radiation 22 and is a common dose-limiting factor in patients receiving chemotherapy. Mucositis is a common toxicity of high-dose chemotherapy that can compromise the entire gastrointestinal (GI) tract from the mouth to the anus including the mucosa of the stomach, small and large intestine, and rectum.23 Generally referred to as alimentary mucositis, it can be further classified by specific anatomic location (eg, OM, GI mucositis).

Clinical expression of OM varies by type of cancer treatment.22 Elting et al 13 reported OM in 22% of cycles of myelosuppressive chemotherapy, GI mucositis in 7% of cycles, and both oral and GI mucositis in 8% of cycles. In patients receiving high-dose radiation for head and neck cancer, the incidence of OM is virtually 100%.24 Oral mucositis is highly prevalent in patients receiving high-dose chemotherapy as a conditioning regimen for HSCT.25 McGuire et al 2 reported that approximately 86% of patients receiving either an allogeneic or autologous transplant experienced OM.

Patient-specific characteristics (eg, sex, age) may influence prevalence and severity of OM. In one study of patients receiving chemotherapy, females reported a higher incidence of OM than men.26 Zalcberg and collegues 27 identified female gender as an independent risk factor for OM. In contrast, Chiara and colleagues 28 reported a significantly higher incidence in OM in males. Patients older than 50 years developed more severe and longer lasting OM in one study, leading researchers to hypothesize that a decline in renal function may be causative.29 Sonis and colleagues 30 reported higher prevalence in children than in adults with the same malignancy.

Oral mucositis incidence is also related to specific chemotherapy agents and regimens. Sonis et al 24 analyzed more than 338 research studies that reported outcomes of chemotherapy and radiation trials and also listed grade III and IV OM. Anthracycline-based regimens were associated with rates of OM of approximately 1% to 10%, including those standard regimens for adjuvant treatment in patients with breast cancer (doxorubicin and cyclophosphamide) and regimens for non-Hodgkin lymphomas (cyclophosphamide, doxorubicin, vincristine, and prednisone). Risk of OM increased when rituximab was added to the regimen. Use of 5-fluorouracil, a common treatment for colon and some breast cancers, resulted in rates of grade III and IV greater than 15%.24 Interestingly, only limited research has been conducted on occurrence of OM in outpatients receiving chemotherapy. In their intervention study comparing chlorhexidine and normal saline mouthwashes in chemotherapy outpatients, Dodd et al 1 reported OM incidence rates of 23% in chlorhexidine and 26% in normal saline groups based on oral cavity assessments at baseline and 3 subsequent cycles of chemotherapy.

This figure could be an underestimate, however, because although patients were encouraged to visit the outpatient clinic if they had OM between cycles, it is not known how many of them adhered to this suggestion.

In addition, data collection occurred at the end of each cycle, when OM had likely resolved, and it was assessed using the Oral Assessment Guide (OAG),31 which is a global oral assessment tool for oral complications of chemotherapy rather than a measure of mucosal tissue damage.

Oral Pain and SM

Oral pain is a clinically significant problem in patients with OM, resulting in decreased quality of life among cancer patients.13 Those patients receiving chemotherapy treatment have a 40% to 70% likelihood of also suffering OM pain.32 Patients undergoing HSCT identified OM pain as the most serious adverse effect in the first 100 days of treatment.33 Oral mucositis pain can be so severe that patients receive opioids or other forms of pain medication for symptom relief. Unfortunately, some patients with mucositis experience breaks in their treatment regimen or decreased doses of chemotherapy.34 To date, OM-associated pain has been primarily investigated in the HSCT population and in patients receiving high-dose chemotherapy but not in patients receiving outpatient chemotherapy.

As noted earlier, patients often refer to the erythema and ulceration ("sores") that characterize OM by using the general term sore mouth. Researchers studying OM have used a variety of tools to measure both objective and subjective components of OM, including tissue damage and self-reported symptoms such as oral pain or soreness.1,2,21 These studies reveal that many researchers have used SM as an objective indicator of OM when it is not possible to precisely measure OM.

For example, in a study of 47 patients undergoing either allogeneic or autologous transplantation, 86% reported oral pain, and of these, more than 50% described the pain as "tender," "aching," and "sharp" on the Short-Form McGill Pain Questionnaire.2 Subsequent work in 18 patients receiving high-dose chemotherapy for bone marrow transplantation revealed that 70% experienced mild to moderate oral pain and frequently described it as tender, "irritating," and sore.21 In another example, Dodd and colleagues 1 reported that of 111 chemotherapy outpatients participating in an interview session and completing the OAG, 69% had OM and many described their mouths as having "slight soreness" and "tenderness" and their throats as having "very painful sores."

Several organizations that provide education about cancer symptoms use the phrase sore mouth to describe OM to their patients. For example, both the American Cancer Society 35 and The National Institute of Dental and Craniofacial Research 36 use the term sore mouth in their materials focusing specifically on OM. Thus, use of sore mouth or similar words (tender) seems common in the context of OM secondary to cancer treatment. Its extensive use by patients, healthcare providers, and organizations clearly validates the authors' exploration of SM as a subjective indicator of OM in the outpatient chemotherapy population.

Association of Symptoms With OM

As noted earlier, McGuire et al 2 found that patients undergoing an allogeneic or autologous transplantation had OM and that 86% reported OM-associated pain. In a subsequent pilot study conducted in preparation for an intervention study of acute oral pain and mucositis in HSCT and leukemia patients (n = 18), McGuire et al 21 reported that mild to moderate OM pain occurred in approximately 70% of participants and noted that patterns of pain, mucositis, and mood disturbances (measured using the 11-item Brief Profile of Mood States 37) were similar in escalation, peaking, and resolution over time.

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