Definition of standardized nutritional assessment and interventional pathways in oncology

Supplement to Nutrition Vol. 12, No. 1, 1996

Definition of Standardized Nutritional Assessment and Interventional Pathways in Oncology F A I T H D. O T r E R Y , M D , P H D , F A C N

From the Society for Nutritional Oncology Adjuvant Therapy, Philadelphia, Pennsylvania, USA ABSTRACT Weight loss and nutritional deterioration are associated with adverse outcomes in terms of cancer prognosis (response rate and survival) as well as increased complications, prolonged hospitalizations, increased risk of unplanned hospitalization, increased disability, and increased overall cost of care. The nutritional oncology service at Fox Chase Cancer Center defined a proactive, standardized assessment and interventional approach from 1987-1994. In 186 consecutive patients referred to the nutrition clinic and managed solely by oral intervention and aggressive symptom management, the team demonstrated a 50%-80% success rate in getting patients to maintain or gain weight during therapy, with a similar success in maintaining or improving visceral protein status as determined by serum transferrin and/or albumin. Evaluation of the home parenteral nutrition program (n = 65, from 1987-1993) demonswated similar success when appropriate triaging was carried out, with 58% of patients able to be tapered off parenteral nutrition (PN) entirely or with transition to enteral tube feeding. The assessment of success for a nua'itional intervention (e.g., a disease-specific nutritional supplement) requires the standardization of definitions, assessment tools, criteria for nutritional intervention, and appropriate end points for the assessment of outcomes. The Patient-Generated Subjective Global Assessment of nutritional status is used in conjunction with the nutritional risk of planned cancer therapy to define a standardized interventional approach in oncology patients, which can be used in clinical practice, cooperative oncology group protocols, and clinical trials of nutritional intervention regimens. Key words: parenteral nutrition, weight loss, visceral protein status, nutritional intervention

INTRODUCTION

Progressive nuaitional deterioration is common in patients with cancer and may either be tumor- or treatment-induced. Weight loss of at least 5% of pre-illness weight is reported in one third of patients with malignancy at initial presentation and is a nearly universal f i n d i n g among patients with a d v a n c e d cancer. Malnutrition frequently contributes to the cause of death in patients with cancer, with as much as 20% of cancer patients succumbing to progressive nutritional deterioration or inanition rather than to the malignancy per se, 2-5 Progressive i n a n i t i o n or wasting (cachexia) has been hypothesized to be related in various ways to distant effects of circulating cytoldnes or other mediators on cellular and systemic metabolism. The specifics of these are discussed in detail by other authors in this symposium. The most consistent clinical finding in weight-losing cancer patients is anorexia--nutritional intake inadequate to meet the protein and energy requirements of the patient. This may be based on poor appetite, delayed gastric

emptying, early satiety, pain, delayed intestinal transit time, fatigue, and depression, as well as with the metabolic changes that have been noted in a wide spectrum of cancer patients. The impact of weight loss on outcome has been recognized since the 1930s, when Studley defined the adverse effect of weight loss in patients with peptic ulcer disease. 6 Weight loss >10% has been confirmed in numerous studies as being associated with an increased risk of morbidity and mortality, regardless of the underlying disease process or the treatment intervention employed. Weight loss per se is a negative prognostic indicator in surgical patients, general hospitalized patients, trauma patients, geriatric patients, and patients with cancer or AIDS. Blackburn et al. ~ quantified the prognostic impact of acuity of weight loss, with severe weight loss defined as that which is associated with a statistically increased risk of morbidity and/or mortality. The criteria for severe weight loss, defined in general hospitalized patients, was >2% loss/week, >5% loss/mo, >7.5% loss in 3 too, and >10% loss in 6 mo.

Correspondence to: Faith D. Ottery, MD, PhD, FACN, Society for Nutritional Oncology Adjuvant Therapy, Pier 5 Suite 139, Philadelphia, PA 19106, USA.

Nutrition 12:S15--S19, 1996 @Elsevier Science Inc. 1996 Printed in the USA. All rights reserved.

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S 16

STANDARDIZED NUTRITIONAL ASSESSMENT

In addition to the adverse impact of weight loss on morbidity and mortality, a significant amount of literature is available c o n c e r n i n g the impact of m a l n u t r i t i o n on the length of hospitalization, frequency of rehospitalization, cost of care, complication rate, and risk of death) In the context of the changing health-care system and in cost considerations of clinical trials, these adverse effects of nutritional deterioration on outcome are an additional reason for proactively addressing nutrition during oncology care. In general, the average lengths of stay (ALOS) of malnourished patients are twice as long as in diagnosis-adjusted, well-nourished patients.9-12 Data from oncology patients treated at the Fox Chase Cancer Center are consistent with reports in other patient populations. During 1993-1994, the ALOS for all patients at Fox Chase was 5.8 days, whereas that of patients with discharge diagnoses of malnutrition (with or without dehydration) were 9.4 and 13.4 days, respectively. It should be noted that the adverse impact of nutritional status in these cancer patients may be even greater than twofold, as the ALOS of the initial group includes data from all p a t i e n t s - - w e l l nourished, as well as those with dehydration or malnutrtion. Several reports concerning the prognostic impact of weight loss in ¢ancer patients have involved the impact of pretreatment weight loss. These have g e n e r a l l y been retrospective and noninterventional. The most widely cited review is that of DeWys et al.13 a retrospective evaluation of 3047 patients with 11 different tumor types treated on 12 different Eastern Cooperative Oncology Group (ECOG) protocols. All patients were beyond the scope of curative resection or radiation therapy. For all tumor types other than pancreatic, patients with weight loss >5% in the 6 mo prior to diagnosis (i.e., pretreatment weight loss) had significantly reduced median survivals. This was related to both decreased response rates to treatment modalities as well as decreased disease-free and overall survival. Evaluation of results is complicated by the fact that patients who lose weight prior to treatment are those who are also at greatest risk of further nutritional deterioration during treatment. This fact emphasizes the need prospectively to address nutritional assessment and intervention in a clinical trial format. The Common Toxicity Criteria for the grading of nutritional or metabolic toxicity associated with chemotherapy (used by the National Cancer Institute and all cooperative oncology groups) are not consistent with the nutritional literature concerning the importance of early treatment of malnutrition and prevention of weight loss. The toxicity grades include Grade 0, <5% loss; Grade l, 5-9.9%; and Grade 2, 10-19.9%. To be categorized as having sustained a Grade 3 nutritional toxicity, a patient undergoing cooperative group protocol therapy has to demonstrate >20% weight loss during therapy. The grading of nutritional toxicity includes no consideration of weight loss acuity or cumulative weight loss (i.e., baseline plus treatment related). It should also be noted that this degree of weight loss is rarely the basis of treatment changes or

standardized nutritional intervention (as would be the case for many other toxicities such as mucositis, vomiting, or neutropenia). ASSESSMENTOF NUTRITIONALRISKAND DEFICIT:USE OF THE PATIENT-GENERATEDSUBJECTIVEGLOBALASSESSMENT(PG-SGA) Several indicators of nutritional risk or nutritional deficit have been used over the past 25 yr, including anthropometrics, laboratory e v a l u a t i o n , and various c a l c u l a t e d n u t r i t i o n a l indices. 14,ts To be useful in either a busy oncology practice or a clinical trial format, a nutritional assessment tool needs to meet the following criteria: easy to use, cost-effective, reproducible in several clinical settings (inpatient, outpatient, clinic, home.care, and hospice), able to predict those patients who need nutritional intervention and who will benefit from nutritional intervention, and have little interobserver variability. The SGA of nutritional status was developed during the 1980s and has been validated as a tool for triaging patients in terms of their n u t r i t i o n a l risk and need for aggressive n u t r i t i o n a l support. ~6-~9 A modification of the original SGA for use in oncology patients is found in Figure 1 This modification (PGSGA) was developed and piloted at Fox Chase Cancer Center. 2° The determination of nutritional risk and nutritional deficit requires the inclusion of both baseline and therapy-related weight loss. The instrument includes all aspects of the original SGA but is wriuen in patient terms, on a sixth- to eighth-grade reading level, with the initial four sections completed by the patient while waiting for the clinician. There is also a Spanish version of the PG-SGA which has been developed but not yet clinically validated. The original SGA was based on the hypothesis that restoration of food intake can rapidly reduce the risks associated with malnutrition. Specifically, it was hypothesized that if nutrient intake can be restored to optimal levels to meet requirements, the risk of complication is low even though a patient is still wasted and underweight. The SGA and PG-SGA are based on a combination of known prognostic indictors of weight loss and performance status, as well as clinical aspects of nutritional intake and its impediments (i.e., nutritional impact symptoms). The first four sections of the PG-SGA are completed by the patient, with the remaining portions of the PG-SGA completed by the clinician (physician, nurse, or dietitian). The clinician portion, in a pilot study at Fox Chase Cancer Center, added
TABLE I. GUIDI~JJNF_,SFOR PATIENTGENERATEDSUBJECTIVE GLOBAL ASSESSMENT CATEGORIES Stage A

Stage B

Stage C

Well nourished*

?_5%weight loss within approximately 1 mo

Any recent nonfluid weight gain and/or Improvementsin components of history,e.g., improved symptoms or intaket

No weight stabilization or weight gain

Obvious signs of malnutrition (e.g., severe loss of SQ tissue, possible peripheral edema) Clear and convincing evidence of weight loss

Definite decrease in intaket; mild subcutaneous tissue loss

* no weight loss, no nutrition impact symptoms, meeting nutrient requirements, normal performance status, and no physical evidence of malnutrition, tPer the checkoff list in the PG-SGA. These are general profiles of each SGA category.For additional information on the guidelines, see Reference 14.

STANDARDIZED NUTRITIONAL ASSESSMENT

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P a t i e n t - G e n e r a t e d S G A * o f N u t r i t i o n a l Status

1. Weight In summary of my current and recent weight:. I currently weigh about I am about _

_

pounds

feet

2. Food Intake As compared to my normal, I would rate my food intake during the past month as either:

tall

A year ago I weighed about

pounds

Six months ago I weighed about

n unchanged

pounds

[] more than usual [] less than usual

During the past two weeks my weight has: 0 decreased [] not changed O increased

I am now taking:

3. Symptoms

,I have had the following problems that kept me from eating enough (check all that apply): [3 no problen~ eating [] no appetite, just did not feel like eating [] nausea 0 vomiting [] constipation [] diarrhea O mouth sores n dry mouth O pain; where? O things taste funny or have no taste [] smells bother me 0 other

4.

[] little solid food 0 only liquids [] only nutritional supplements [] very little of anything

Functional Capacity Over the past month, I would rate my activity as generally: r~ normal with no limitations n not my normal self, but able to be up and about with fairly normal activities [] not feeling up to most things, but in bed less than half the day [] able to do tittle activity and spend most of the day in bed or chair [] pretty much bedridden, rarely out of bed

THE REMAINDER OF THIS FORM WILL BE COMPLETED BY YOUR DOCTOR, NURSE, OR THERAPIST.THANK YOU. 5. Diseeseand Its Re|aUonto NubttJonalRequirements

Primary diagnosis (specify) StaKe,if known Metabolicdemand(stress):

r'3no stress

For each Irait specify=. 0 = n o r m a l

1. mild

loss o f subcutaneous

fat (triceps,chest)

Select one r'3 A = weU nourished = Subjective Glebal Assessment

r'l low stress

2 = moderate

muscle wasting

[] moderatestress

[] high stress

3 = severe ankle edema

sacral edema

_ _

ascites

(qusdricep~, deltoids)

i-1 B = moderete]y (or su,spected of being) malnourished

t-1 C = severely malnourished C) I '.,'q5

FIG. 1. The PG-SGAis a modificationof the originalSGAis-j9to be used in oacologypatientswith the initialfour sectionscompletedby the patientand the remainingsectionscompletedby the oncologyclinician(physician.nurse,or dietitian).

SIS

STANDARDIZED NUTRI~ONAI~ ASSESSMENT

Algorithm of Optimal Nutritional Intervention Baseline SGA Nutritional Assessment

SGA-A

~

low-risk therapy

SGA-B

Mlih-dsk therapy

Gonemt Nutrition Education (eO, NCI Eating Hint~ pamphlet)

SGA reasseasment at each oncologlst" VIsRor admission

deterioration

SG/~ reassessment at each oncologlst" visit or admission

I

low-risk therapy

'

~

.SGA-C

Specific Nutrition Education

Specialized Nubflion ~emntion

1. into by specific diagnosis (eg, "stinky stools" with pancreatic cancer and fat malabsorpfion) 2. Into by specific therapy (cO, metallic taste with cisplatin; stomaMis with XRT or M'I'X) 3. Into on symptom management and baseline treatment as indicated (eg, pain, nausea. constipation, anorexia)

(co, nutrition clinic, oncolooy dietitian, nurse specialist, physician, nutrition support service) patient specific coonseflng aggressive symptom management tdage to oral, I"F, or PN as necessary

SGA nmsssssmant at I or 2 weeks

SGA reassessment at each oncoinglst" visit or admission

improvement or stabilization

i

SGA reassessment at each oncologist" visit or admission

anydsk therapy

blllh-dsk therapy

dependentupon patientandthemw

deterioration |

Gi

parenteml " nutrition

improvement or stabilization $GA rssssessment at each oncologist • visit or admission

reassess in 1week

SGA massassment at each oncologist ° visit or admission

successful

unsuccessful

• medical oncoloiiist = q 3-4 weeks; radiation oncolooist = q week.

©1995

FIG. 2. The algorithm is based on a patient's nutritional staging according to the PG-SGA and the nutritional risk of the cancer therapy (e.g., nausea, vomiting, stomatitis). Re~ssessment is coordinated with the visit to the oooo[ogist, to facilitate the treatment of nu~tion impact symptoms. Each episode of nutritional deterioration requires a change in regimen or route of intervention. The heavy dashed lines represent the approach in those patients who require early or immediate intervention with enteral or parenteral nutrition.

STANDARDIZED NUTRITIONAL ASSESSMENT

S 19

After the patient and clinician assessments are completed, a nutritional staging is given: (A) well nourished; (B) moderately, or suspected of being, malnourished; or (C) severely malnourished. General category profiles, as defined by the original SGA, are found in Table I) 4 ALGORITHMOF OPTIMALNUTRITIONALINTERVENTION Specific aspects of nutritional intervention in oncology patients have been defined by O t t e r / a n d co-workers at the Fox Chase Cancer Center. The algorithm of optimal nutritional intervention as seen in Figure 2 is based on clinical practice and clinical research of the nutritional oncology service at that institution from 1987-1994. A l t h o u g h at first glance the a l g o r i t h m may appear to be complicated, only two components are needed to define the general approach in a given patient: the PG-SGA staging (A, B, or C) and a determination of whether the patient is being placed on nutritionally high-risk or low-risk cancer therapy. High-risk cancer therapy is defined as that in which there is an approximate risk of 30%-50% of severe nutritional impact symptoms (e.g., nausea, vomiting, diarrhea, stomatitis/mucositis, sensory changes or aversions). In terms of radiation therapy, the location and size of the radiation port, size and frequency of fractionation, and whether the treatment is part of a multimodality treatment regimen all affect the risk of nutritional deterioration and weight loss. Based on the patient's baseline deficit and the nutritional risk of the cancer therapy, intervention may range from the use of simple patient educational materials to the use of proactive or prophylactic enteral tube

feedings or parenteral nutrition. Using the format of a proactive, standardized nutritional assessment and interventional approach, the Fox Chase Cancer Center's nutritional oncology service had the following results: in 186 consecutive patients referred to the nutrition clinic (average w e i g h t loss of 16.8%) who were m a n a g e d solely by oral intervention and aggressive symptom management, there was a 50% success rate in getting patients to maintain or gain weight during therapy and maintain or improve visceral protein status, as determined by serum transferrin and/or albumin. If data from patients with life expectancy <6 weeks are excluded, there was an approximately 80% success rate in getting patients to maintain or gain weight during therapy and maintain or improve visceral protein status, as determined by serum transferrin and/or albumin. Results of the home parenteral nutrition program (n = 65, from 1987-1993) were similarly successful when appropriate triaging was carried out, with 58% of patients able to be tapered off parenteral nutrition entirely or with transition to enteral tube feeding. Of these, 55% were able to be off parenteral nutrition in the long term (>l yr prior to death from cancer) or permanently. 2s In conclusion, the use of a standardized nutritional assessment tool and a standardized interventional approach is defined which allows proaedve rather than reactive approaches to the prevention and management of cancer cachexia. The approach is appropriate to general patient care, cooperative oncology group protocols, and clinical trials of nutritional intervention.

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