June 2008, Supplement to Volume 12, Number 3

 

Article

Gastrointestinal Side Effects Associated With Novel Therapies in Patients With Multiple Myeloma: Consensus Statement of the IMF Nurse Leadership Board

Lisa C. Smith, MSN, FNP, AOCN®, Page Bertolotti, RN, BSN, OCN®, Kathleen Curran, RN, MSN, CRNP, Bonnie Jenkins, RN, and the IMF Nurse Leadership Board

 

 

The novel immunomodulatory drugs lenalidomide and thalidomide and the novel proteasome inhibitor bortezomib can cause gastrointestinal side effects, including constipation, diarrhea, nausea, and vomiting, which can have a deleterious effect on quality of life and interfere with optimal therapy. The International Myeloma Foundation’s Nurse Leadership Board developed this consensus statement for the management of gastrointestinal side effects associated with novel therapies to be used by healthcare providers in any medical setting. It includes grading criteria and general recommendations for assessing and managing the side effects. Although constipation, diarrhea, nausea, and vomiting are expected side effects associated with novel therapies for multiple myeloma, they are manageable with appropriate medical interventions.

 

At a Glance

 

·         Lenalidomide, thalidomide, and bortezomib can cause serious gastrointestinal side effects.

·         Adequate management of the toxicities can increase adherence to treatment, decrease impairment, improve quality of life, and prevent serious adverse events leading to prolonged hospitalization and increased morbidity and mortality.

·         This article provides recommendations to assist healthcare providers in any medical setting to manage the gastrointestinal side effects.

 

Novel therapies for multiple myeloma include the immunomodulatory drugs lenalidomide (Revlimid®, Celgene Corporation) and thalidomide (Thalomid®, Celgene Corporation) and the proteasome inhibitor bortezomib (Velcade®, Millennium Pharmaceuticals, Inc.). The benefits of the agents for patients with multiple myeloma include increased response rates and survival times compared with conventional chemotherapy (e.g., melphalan plus prednisone; or vincristine, adriamycin, and dexamethasone) (Celgene Corporation, 2007a, 2007b; Ghobrial et al., 2007; Manochakian, Miller, & Chanan-Khan, 2007; Millennium Pharmaceuticals, Inc., 2007; Rajkumar et al., 2005; Richardson & Anderson, 2006; Richardson, Hideshima, Mitsiades, & Anderson, 2007).

 

Like conventional chemotherapeutic agents, the novel therapies can cause serious side effects. Among them are gastrointestinal side effects, including constipation, diarrhea, nausea, and vomiting, which, although predictable and manageable, can be life threatening and interfere with adherence to optimal therapy and quality of life (Celgene Corporation, 2007a, 2007b; Millennium Pharmaceuticals, Inc., 2007). The International Myeloma Foundation’s Nurse Leadership Board, in recognition of the need for specific recommendations on managing key side effects of novel antimyeloma agents, developed this consensus statement for the management of constipation, diarrhea, nausea, and vomiting associated with lenalidomide, thalidomide, and bortezomib. The statement can be used by healthcare providers in any type of medical setting (Bertolotti et al., 2007, 2008). The recommendations, which were developed through evidence-based reviews and a consensus of the Nurse Leadership Board, also are applicable for managing gastrointestinal side effects caused by any chemotherapeutic agent.

 

Issue Statement

 

Gastrointestinal toxicities are common sequelae of treatment with novel therapies, including lenalidomide, thalidomide, and bortezomib. Although they are addressed often, they may not be managed adequately. Inadequate management of constipation, diarrhea, nausea, or vomiting can affect patients in multiple ways. Physical effects can lead to decreased adherence to treatment regimens. Psychological effects include anxiety and depression. Patients may become socially isolated and experience decreased function and abilities. Adequate management of gastrointestinal toxicities increases patient adherence to treatment regimens, decreases physiologic impairment, improves quality of life for patients and their caregivers, and prevents serious adverse events that lead to prolonged hospitalization and increased morbidity and mortality.

 

This consensus statement and the tools provided address the gastrointestinal toxicities of constipation, diarrhea, nausea, and vomiting and will allow oncology nurses, as part of interdisciplinary teams, to be better prepared to manage toxicities associated with novel therapies.

 

Toxicity Tool for Grading

 

The severity of gastrointestinal adverse events can be quantified with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). The NCI CTCAE are used for identifying treatment-related adverse events to facilitate the evaluation of new cancer therapies, treatment modalities, and supportive measures. For most adverse events, the NCI CTCAE define grades 1–5 using unique clinical descriptions; each grade is assigned a severity: grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling, and grade 5 defines death associated with the adverse event. The grades may be used for monitoring gastrointestinal side effects and determining the need for intervention and dosage modifications. Table 1 defines the NCI CTCAE version 3.0 toxicity grades for constipation, diarrhea, nausea, and vomiting (NCI, 2006).

 

Incidence, Risk Factors, and Assessments for Gastrointestinal Toxicities

 

Table 2 presents the incidence of gastrointestinal toxicities in patients with multiple myeloma receiving lenalidomide, thalidomide, or bortezomib in clinical trials. Table 3 lists risk factors other than treatment with novel therapies that may cause constipation, diarrhea, nausea, or vomiting in patients with multiple myeloma. Table 4 outlines risk assessments for gastrointestinal toxicities in patients receiving novel therapies for multiple myeloma based on clinical observations, patient history, and physical and laboratory examinations.

 

Recommendations for Constipation

 

Constipation is defined as decreased frequency of defecation, usually less than three bowel movements per week, with accompanying abdominal discomfort. It is a common issue in patients with cancer because of poor oral intake or because of drugs such as opioids or antiemetics, which slow intestinal transit time. Constipation can be a disabling toxicity and often is underassessed and undertreated in patients with cancer (American Society of Clinical Oncology [ASCO], 2005a; Mercadante, 2007; NCI, 2007a). Table 5 provides management strategies for constipation by CTCAE version 3.0 grades 1–4. Appendix A offers the Oncology Nursing Society Putting Evidence Into Practice® recommendations.

 

Recommendations for Diarrhea

 

Diarrhea is defined as an abnormal increase in the amount of fluid in stool. Severe and uncontrolled diarrhea can lead to dehydration and electrolyte imbalances, exacerbate underlying renal dysfunction, decrease quality of life, and increase emotional distress. Nurses are in a pivotal position to evaluate patients’ risk for diarrhea and implement the necessary steps to prevent and treat the potentially serious adverse event (ASCO, 2005b; Bush, 2004; Engelking, 2004; Mercadante, 2007).

 

Ineffective management of diarrhea not only leads to poor clinical outcomes but also has a negative impact on quality of life, including alteration of roles, responsibilities, and interpersonal relationships, and it can cause social isolation. Many patients with diarrhea are acutely embarrassed and will not discuss the issue with healthcare providers. Some fear that disclosure will cause reductions or delays in treatment. Fear of incontinence and the possibility of embarrassment often leave patients “trapped” at home. Eventually, altered body image, low self-esteem, depression, anxiety, and hopelessness may occur (Engelking, 2004). Once a patient has been determined to be at risk for or is experiencing diarrhea, the Nurse Leadership Board recommends appropriate prophylactic and therapeutic interventions and an effective diarrhea management plan. Table 5 presents recommendations for management of diarrhea by CTCAE version 3.0 grades 1–4.

 

Recommendations for Nausea

 

Nausea is defined as an uncomfortable, unpleasant feeling in the back of the throat or in the stomach that may or may not result in vomiting. Other common terms used to describe nausea are “sick to my stomach” and “queasy.” Increased saliva, dizziness, light-headedness, difficulty swallowing, changes in skin temperature, and fast heart rate are other symptoms that may occur as a result of nausea. Although nausea and vomiting are separate phenomena, risk factors and assessments are similar. Treatment-related nausea may be a difficult symptom to manage in patients with advanced cancer (ASCO, 2005c; Berger & Clark-Snow, 2005, 2007; Dalal, Palat, & Bruera, 2007; Grunberg, 2007; NCI, 2007b). Many patients worry that nausea is inevitable after treatment with anticancer agents, and it is second only to fatigue as an expected side effect (Hofman et al., 2004). The expectation of nausea has been shown to be correlated with its development during treatment (Hofman et al.). With antiemetic therapy and appropriate care and advice, the incidence and severity of nausea can be reduced (Berger & Clark-Snow, 2007). Antiemetic therapies, which also may be helpful for nausea, are listed in Appendix B. Antiemetics for older patients should have the following characteristics.

       A low risk of drug-drug interactions

       No cardiovascular side effects

       A simple, convenient dosing regimen

       No dose adjustments in patients with impaired kidney or liver function

 

Once a patient has been determined to have or to be at risk for nausea, the IMF Nurse Leadership Board recommends appropriate prophylactic and therapeutic interventions and an effective nausea management plan. Acute nausea usually occurs within a few minutes to several hours after administration of anticancer agents and often resolves in the first 24 hours. Delayed nausea occurs more than 24 hours after administration of anticancer agents. It often peaks 48–72 hours after treatment and can last six or seven days. Patients also may experience anticipatory nausea, which occurs before they receive anticancer treatment. Anticipatory nausea is a conditioned response and can occur before a subsequent treatment with an anticancer agent that previously caused nausea (Tipton et al., 2006). Although anticipatory nausea has no CTCAE category or grade, it requires management with preventive strategies (see Figure 1). Such strategies also form the basis of management of therapy-associated nausea; see Table 5 for recommendations for management of nausea by CTCAE version 3.0 grades 1–4.

 

Recommendations for Vomiting

 

Vomiting often is confused with nausea but is, in fact, a separate phenomenon that may or may not occur in conjunction with nausea. It is a self-protective mechanism by which the body attempts to expel toxins. Vomiting involves the expulsion of gastric contents through the mouth. The action is caused by the forceful and spasmodic contraction of the abdominal muscles and diaphragm (ASCO, 2005c; Berger & Clark-Snow 2005, 2007; Dalal et al., 2007; Glare, Pereira, Kristjanson, Stockler, & Tattersall, 2004). Like nausea, vomiting can be anticipatory, acute, or delayed (Tipton et al., 2006).

 

Vomiting, along with nausea, is considered one of the most disturbing and feared side effects of cancer treatment (ASCO, 2005c). The Nurse Leadership Board believes that ineffective management of vomiting has a negative effect on quality of life, often leading to anxiety and depression, delayed recovery, poor clinical outcomes, anticipatory vomiting, and aversion to future treatments. Many patients even consider stopping treatments to avoid vomiting. However, vomiting can be one of the most manageable side effects of cancer treatment. Table 5 presents recommendations for management of vomiting by CTCAE version 3.0 grades 1–4.

 

Dose Modification of Novel Therapies

 

In addition to using the general strategic recommendations for management of gastrointestinal toxicities associated with novel agents for multiple myeloma, healthcare professionals may consider dose modifications, particularly when symptoms are severe. The labeling for lenalidomide describes dose modification recommendations for grade 3 and 4 toxicities judged to be related to lenalidomide therapy. The labeling for thalidomide describes dose modification recommendations for constipation. The labeling for bortezomib describes dose modifications for any grade 3 nonhematologic toxicity. They are summarized in Table 6.

 

Therapies for multiple myeloma, including the newer therapies, can cause gastrointestinal side effects, including constipation, diarrhea, nausea, and vomiting, which can have a deleterious effect on quality of life, lead to or prolong hospitalization, and interfere with optimal therapy. However, with appropriate medical interventions, the side effects are manageable, and their impact on patient quality of life and adherence to therapy can be minimized.

 

The authors gratefully acknowledge Brian G.M. Durie, MD, and Robert A. Kyle, MD, for critical review of the manuscript and Lynne Lederman, PhD, medical writer for the International Myeloma Foundation, for assistance in preparation of the manuscript.

 

References

 

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Bertolotti, P., Bilotti, E., Colson, K., Curran, K., Doss, D., Faiman, B., et al. (2008). Management of side effects of novel therapies for multiple myeloma: Consensus statements developed by the International Myeloma Foundation’s Nurse Leadership Board. Clinical Journal of Oncology Nursing, 12(3, Suppl.), 9–12.

 

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Glare, P., Pereira, G., Kristjanson, L.J., Stockler, M., & Tattersall, M. (2004). Systematic review of the efficacy of antiemetics in the treatment of nausea in patients with far-advanced cancer. Supportive Care in Cancer, 12(6), 432–440. [CrossRef]

 

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Hofman, M., Morrow, G.R., Roscoe, J.A., Hickok, J.T., Mustian, K.M., Moore, D.F., et al. (2004). Cancer patient’s expectations of experiencing treatment-related side effects: A University of Rochester Cancer Center—Community Clinical Oncology Program study of 938 patients from community practices. Cancer, 101(4), 851–857.

 

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Manochakian, R., Miller, K.C., & Chanan-Khan, A.A. (2007). Clinical impact of bortezomib in frontline regimens for patients with multiple myeloma. Oncologist, 12(8), 978–990. [CrossRef]

 

Mercadante, S. (2007). Diarrhea, malabsorption, and constipation. In A.M. Berger, J.L. Shuster, & J.H. Von Roenn (Eds.), Principles and practice of palliative care and supportive oncology (3rd ed.). Philadelphia: Lippincott Williams and Wilkins.

 

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Molassiotis, A., Yung, H.P., Yam, B.M., Chan, F.Y., & Mok, T.S. (2002). The effectiveness of progressive muscle relaxation training in managing chemotherapy-induced nausea and vomiting in Chinese breast cancer patients: A randomized controlled trial. Supportive Care in Cancer, 10(3), 237–246.  [CrossRef]

 

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National Cancer Institute. (2007b). Nausea and vomiting (PDQ®) Retrieved October 29, 2007, from http://www.cancer.gov/cancertopics/pdq/supportivecare/nausea/healthprofessional/allpages

 

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National Comprehensive Cancer Network & American Cancer Society. (2007). Nausea and vomiting: Treatment guidelines for patients with cancer. Retrieved September 10, 2007, from http://www.nccn.org/patients/patient_gls/_english/pdf/NCCN%20Nausea%20Guidelines.pdf

 

Rajkumar, S.V., Hayman, S.R., Lacy, M.Q., Dispenzieri, A., Geyer, S.M., Kabat, B., et al. (2005). Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood, 106(13), 4050–4053.  [CrossRef]

 

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Richardson, P.G., & Anderson, K. (2006). Thalidomide and dexamethasone: A new standard of care for initial therapy in multiple myeloma. Journal of Clinical Oncology, 24(3), 334–336. [CrossRef]

 

Richardson, P.G., Hideshima, T., Mitsiades, C., & Anderson, K.C. (2007). The emerging role of novel therapies for the treatment of relapsed myeloma. Journal of the National Comprehensive Cancer Network, 5(2), 149–162.

 

San Miguel, J., Blade, J., Boccadoro, M., Cavenagh, J., Glassmacher, A., Jagannath, S., et al. (2006). A practical update on the use of bortezomib in the management of multiple myeloma. Oncologist, 11(1), 51–61. [CrossRef]

 

Shen, J., Wenger, N., Glaspy, J., Hays, R.D., Albert, P.S., Choi, C., et al. (2000). Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. JAMA, 284(21), 2755–2761. [CrossRef]

 

Tipton, J., McDaniel, R., Barbour, L., Johnston, M.P., LeRoy, P., Kayne, M., et al. (2006). Putting Evidence into Practice®: Chemotherapy-induced nausea and vomiting. Retrieved October 29, 2007, from http://www.ons.org/outcomes/volume1/nausea.shtml

 

Lisa C. Smith, MSN, FNP, AOCN®, is a nurse practitioner at the Cancer Centers of the Carolinas in Greenville, SC; Page Bertolotti, RN, BSN, OCN®, is an oncology nurse at the Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute in Los Angeles, CA; Kathleen Curran, RN, MSN, CRNP, is a certified registered nurse practitioner at the University of Pittsburgh Medical Center–Shadyside Hospital in Pennsylvania; and Bonnie Jenkins, RN, is the director of program coordination at the Myeloma Institute for Research and Therapy at the University of Arkansas in Little Rock. Smith and Curran are members of the speakers bureaus for Celgene Corporation and Millennium Pharmaceuticals, Inc. Bertolotti is a member of the speakers bureaus for Celgene Corporation and Ortho Biotech Products, L.P. Mention of specific products and opinions related to those products do not indicate or imply endorsement by the Clinical Journal of Oncology Nursing or the Oncology Nursing Society. (Submitted October 2008. Accepted for publication January 5, 2008.)

 

Author Contact: Lisa C. Smith, MSN, FNP, AOCN®, can be reached at lcsmith65@hotmail.com, with copy to editor at CJONEditor@ons.org.

 

Digital Object Identifier:10.1188/08.CJON.S1.37-51

 

Patient Education Sheet: Managing Gastrointestinal Side Effects of Novel Agents for Multiple Myeloma

 

Key points

 

Novel therapies used to treat multiple myeloma include thalidomide, lenalidomide, and bortezomib. Each of the drugs, alone or in combination, may be associated with gastrointestinal side effects, including nausea, vomiting, diarrhea, and constipation. Managing the side effects can reduce your discomfort and can allow you to receive the best treatment for your myeloma. Your healthcare provider may change your dose or schedule of medication to help manage your symptoms. Do not stop or adjust medications without discussing it with your healthcare provider.

 

Types of Gastrointestinal symptoms

 

       Nausea: an unpleasant feeling in the throat and stomach

       Vomiting: a forceful emptying of the stomach contents

       Constipation: decreased frequency of defecation accompanied by discomfort and difficulty

       Diarrhea: an abnormal increase in the frequency and the amount of fluid in the stool

       Always report symptoms early to your healthcare team.

 

Management of Nausea

 

       You may be asked about the circumstances surrounding episodes, upper abdominal pain, pain when swallowing, hiccups or heartburn, weight loss, dizziness on standing up, and your medication history.

       General nausea: Eat small, frequent meals; do not eat fatty or fried foods; avoid strong odors; do not exercise after eating; wear loose clothing; begin appropriate medications before chemotherapy; use relaxation, acupuncture, biofeedback, and guided imagery.

       Loss of appetite, still able to eat normally: Adjust dosages of medications, drink enough water and other fluids, and keep track of effects of medications in a daily diary.

       Decreased ability to eat or drink: Consider asking for increased or different medications and see your physician for physical examination and evaluation.

       Inability to eat or drink: You may need hospitalization or medications through a vein. Call a physician immediately.

       Medications that may be ordered by your healthcare team: lorazepam, prochlorperazine, promethazine, metoclopramide, ranitidine, famotidine, and dexamethasone

 

Management of Vomiting

 

       You will be asked about the appearance of the fluid, whether digested or undigested, whether a “trigger” was involved, whether it was new or different from other times.

       One episode in 24 hours: This is usually self-limiting; continue medications for nausea.

       Two to five episodes in 24 hours: New medications, oral or through a vein, may be needed. Contact a physician immediately.

       Six or more episodes in 24 hours: This may require hospitalization to assess fluid status and rule out bowel obstruction. Contact a physician immediately.

       Medications that may be ordered by your healthcare team: aprepitant, ondansetron, and granisetron

 

Management of Constipation

 

       You will be asked about any abdominal pain, bloating, nausea and vomiting, inability to urinate, confusion, and diarrhea alternating with constipation.

       Mild: Increase fluid and fiber intake, increase physical activity, and start stool softeners

       Moderate: You may need to speak with a dietician about your food intake; consider laxatives and stimulants.

       Severe: Bowel obstruction should be assessed by a physician; dehydration may require fluids through a vein; treatment for an impacted colon may be discussed; medication changes may be ordered by physician; referral to a gastrointestinal specialist may be arranged by a physician.

       Medications that may be ordered by your healthcare team:  docusate, senna, magnesium sulfate, magnesium citrate, lactulose, and bisacodyl

 

Management of Diarrhea

 

       You will be asked about any history of irritable bowel syndrome, colitis, diverticulitis, and medications other than routine chemotherapy. The physician will want to know whether you have “gas” and whether the diarrhea is a “leakage” or sudden.

       Fewer than four stools a day: Drink more liquids; avoid caffeinated, carbonated, heavily sugared beverages; dietary changes may be needed; discontinue any medications that cause diarrhea; keep the rectal area clean.

       Four to six stools per day: Medications may be considered, and you may need fluids and salts. A physician must be notified if you have more than four to six stools per day for more than 24 hours.

       Seven to nine stools per day: Hospitalization may be considered for fluid replacement, a stool culture will be ordered to see whether the diarrhea is the result of an infection, and medications will be given to control frequency. You should take very good care of your skin and use disposable pads or diapers. Cancer therapy may be stopped for a period of time, or the dose may be lowered.

       Medications that may be ordered by your healthcare team: imodium, diphenoxylate, and octreotide

 

Note. For more information, please contact the International Myeloma Foundation (1-800-452-CURE; www.myeloma.org). The foundation offers the Myeloma ManagerTM Personal Care AssistantTM computer program to help patients and healthcare providers keep track of information and treatments. Visit http://manager.myeloma.org to download the free software.

 

Note. Patient education sheets were developed in June 2008 based on the International Myeloma Foundation Nurse Leadership Board’s consensus guidelines. They may be reproduced for noncommercial use.