Effect of nutrition impact symptoms on oral nutritional supplements energy intake in head and neck cancer patients treated by chemotherapy: a retrospective, cross-sectional study

doi:10.21203/rs.3.rs-3141259/v1

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Effect of nutrition impact symptoms on oral nutritional supplements energy intake in head and neck cancer patients treated by chemotherapy: a retrospective, cross-sectional study

https://doi.org/10.21203/rs.3.rs-3141259/v1

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Background

This study aims to explore the effect of nutritional impact symptoms (NIS) on oral nutritional supplements (ONS) energy intake among head and neck cancer (HNC) patients.

Methods

A retrospective, cross-sectional study was conducted in HNC patients in a hospital in western China between January 2019 and June 2020. The NIS were from the “self-reported symptoms affecting dietary intake” of the Patient-Generated Subjective Global Assessment (PG-SGA) scale. Binary logistic regression was used to determine the effect of NIS on ONS energy intake.

Results

The most prevalent five NIS were no appetite (43.8%), nausea (18.8%), dysphagia (15.4%), vomiting (15.0%) and early satiety (12.9%), respectively. And patients with nausea (OR 0.26, 95% CI 0.12–0.57) or vomiting (OR 0.34, 95% CI 0.15–0.80) or early satiety (OR 0.41, 95% CI 0.17–0.97) were less likely to have ONS energy intake > 400 kcal/d than those without these symptoms after adjusting for the confounding factors.

Conclusion

Nausea, vomiting or early satiety should be focused and intervened to improve the nutritional status of the HNC patients.

Oral nutritional supplements (ONS)

nutrition impact symptoms

head and neck cancer

ONS energy intake

Among head and neck cancer (HNC) patients, approximately 35 to 60% are malnourished at diagnosis because of tumor burden, reduced dietary intake, or cancer-related anorexia and cachexia,¹ and the incidence of malnutrition increases throughout treatment.² Malnutrition is associated with increased morbidity and mortality in HNC patients.³

Nutritional impact symptoms (NIS) are adverse symptoms that affect oral intake.⁴ HNC patients could obtain a significant burden of NIS before chemoradiotherapy.⁵ NIS burden is a risk factor for reduced dietary intake, weight loss, and survival.⁵ The NIS score of HNC patients increased during chemoradiotherapy.⁶ NIS due to head and neck chemoradiotherapy is common, including dysphagia, dry mouth, salivary gland problems, mucositis, oral pain and so on.⁷ These NIS may cause pain and inflammatory responses, thereby limiting energy intake, increasing stress responses, leading to weight loss and malnutrition, and even psychological problems.^8,9 Studies have shown that the severity degree of NIS during treatment was positively associated with weight loss in HNC patients.¹⁰

Oral nutritional supplementations (ONS) can improve dietary energy intake, nutritional status, and weight loss and offer better tolerance to treatment in cancer patients.^6,11,12 In ESPEN guideline, ONS was defined as “Supplementary oral intake of dietary food for special medical purposes in addition to the normal food”.¹³ ONS is a nutritional liquid, semi-solid or powder that provides a variety of macronutrients and micronutrients for the purpose of increasing oral nutrient intake.¹⁴ As a special nutritional supplement formula, ONS can enhance the content of protein, carbohydrates, fats, minerals, vitamins and other nutrients in food, and provide balanced nutrients to meet the needs of the body for nutrients.¹⁴ And ONS is the preferred nutritional treatment for patients with malnutrition or nutritional risk without enteral nutritional contraindications.^14,15 ONS is needed for people when dietary energy intake is not expected to reach more than 60% of the recommended energy intake over 10 days, and ONS should be at least 400 to 600 kcal/d in addition to dietary intake.¹⁶ In addition, ONS has a lot of benefits for people with nutritional risk, such as increasing the body mass of patients, reducing the incidence of mortality and complications, and reducing the proportion of hospital readmission.¹⁴ Many studies have found that ONS is beneficial to nutrition improvement in HNC cancer patients.^17,18

NIS is an important factor influencing the need for nutrition support,¹⁹ and patients with higher NIS score may have more need for nutrition support.¹² Most patients with NIS burden tend to choose ONS as meal replacements.^6,12 Most ONS are liquid or powder, which may produce less satiety than solid foods and can be easier to ingest.²⁰ A previous study found that the NIS score during radiotherapy was positively associated with ONS energy and ONS protein intake.⁶ In addition, NIS will affect the compliance of ONS, and poor compliance of ONS will lead to more weight loss in HNC patients.^6,21

To the best of our knowledge, there were no studies of the effect of NIS on nutrition support in HNC patients in China.²² Exploring the effect of NIS on nutrition support could help to develop targeted nutrition program to improve the nutrition status in HNC patients during chemotherapy.²³

2.1 Participants and Data Collection

This study is a retrospective, cross-sectional study. This study included inpatients diagnosed with HNC at a certain hospital in western China between January 2019 and June 2020. And the data used in this study was retrospective data retrieval. Eligibility criteria for patients were as follows: (a) nutritional risk screening (NRS) 2002 scores ≥ 3; (b) can take food orally; (c) treated by chemotherapy; (d) have no history of mental or psychological disease, hematological diseases, and other malignant tumors. Patients aged ≤ 18 years were excluded (13). Finally, 240 subjects were included in the analysis. Research Ethics Committee approval for the study was granted by West China Hospital Research Ethics Committee in October 2019.

2.2 Instruments

2.2.1 Exposure Variables: NIS

The PG-SGA is a subjective overall nutritional status rating scale.^24,25 The scores were assessed by dieticians in the Department of Clinical Nutrition through a history questionnaire.²⁵ PG-SGA is composed of two part of “patient self-assessment” and “medical staff evaluation”, specifically, including “weight”, “food intake”, “self-reported symptoms affecting dietary intake”, “activities and function”, “disease and its relation to nutritional requirements”, “metabolic demand”, and “physical examination”, the first four aspects were assessed by patients themselves, the latter three aspects were assessed by the medical staff.^25,26 The overall assessment result included qualitative assessment and quantitative assessment. A higher PG-SGA score indicated poorer nutritional status.²⁷ According to the PG-SGA scores, the patients were categorized as Stage A (well nourished, or ‘not undernourished’; scored 0–1 point), Stage B (moderately malnourished or suspected malnutrition; scored 2–8 point), or Stage C (severely malnourished; scored ≥ 9 point).²⁶ The NIS were from the “self-reported symptoms affecting dietary intake” of the PG-SGA scale, including “no dietary problem” (scored 0 point), “no appetite, don’t want to eat” (scored 3 point), “nausea”(scored 1 point), “vomit”(scored 3 point), “constipation”(scored 1 point), “diarrhea”(scored 3 point), “dental ulcer”(scored 2 point), “orally dry”(scored 1 point), “no taste or abnormal taste”(scored 1 point), “food odor interference”(scored 1 point), “dysphagia”(scored 2 point), “early satiety”(scored 1 point), “pain”(scored 3 point), and “other (e.g., emotional low, money or tooth problems)”(scored 1 point).²⁶

2.2.2 Outcome Variables: ONS energy intake

The ONS energy intake was retrospective data retrieval by a nutritionist in this hospital. Nutritionists in the hospital were responsible for formulating and adjusting the ONS intervention scheme. And the dietary energy intake of the patients is not expected to reach more than 60% of the recommended energy intake over 10 days. In the study, the patients consumed ONS with food for special medical purpose (FSMP) from Department of Clinical Nutrition, West China Hospital. According to a systematic review in 2020, it is recommended that ONS should be at least 400 to 600 kcal/d in addition to dietary intake.¹⁶ Therefore, the average ONS energy intake was categorized as > 400 kcal/d and ≤ 400 kcal/d.

2.2.3 Covariates

The patients’ age, sex, tumor-related surgery history, tumor recurrence or metastasis, age-adjusted Charlson Comorbidity Index (aCCI),²⁸ smoking history, drinking history and neoplasm staging were collected from the medical records by the researchers. BMI, weight change in the last 2 weeks and physical activity in the last month analyzed in the study were also from the PG-SGA scale. Physical activity was assessed using the Eastern Cooperative Oncology Group (ECOG) performance status assessment standard, which contained 5 grades. Grade 1 refers “normal with no limitations”; grade 2 refers “not my normal self, but able to be up and about with fairly normal activities”; grade 3 refers “not feeling up to most things, but in bed or chair less than half the day”; grade 4 refers “able to do little activity and spend most of the day in bed or chair”; and grade 5 refers “pretty much bed ridden, rarely out of bed”.²⁵

2.3 Data Analysis

Descriptive statistics were used for the sample characteristics. Categorical variables were described using frequencies and percentages, and continuous variables were described using the mean and standard deviation (SD)/median and interquartile range (IQR). To determine the effect of NIS on different ONS energy intake (≤ 400 kcal/d and > 400 kcal/d), odds ratios (ORs) and 95% confidence intervals (CIs) for the outcome variables were calculated using binary logistic regression. Two models for each outcome variable were used: model 1 was unadjusted, and model 2 was adjusted for age, sex, BMI, weight change in the last 2 weeks, physical activity in the last month, treatment regimen, tumor-related surgery history, tumor recurrence or metastasis, aCCI, smoking history, drinking history and neoplasm staging. The Pearson goodness-of-fit test indicated that all logistic regression models used in this study were good fits (P > 0.05).

All analyses were performed using STATA software (Version 15, StataCorp, College Station, TX, USA). Statistical significance was considered when P < 0.05 (two-sided).

Table 1 presents the basic characteristics of the participants. Among the patients, the mean age was 51.4 (SD 15.7) years old, and 44.2% were male. The aCCI of the patients was 6.9. About 30% of the patients had tumor-related surgery, and more than 70% of the patients were primary tumor with metastasis. In addition, more than 50% of the patients were in stage IV of tumor. The median of ONS energy intake was 475 kcal/d, respectively. Patients with ONS energy intake > 400 kcal/d accounted for 65.4%.

Table 2 showed the NIS among the patients. The five highest proportions of NIS were no appetite (43.8%), nausea (18.8%), dysphagia (15.4%), vomiting (15.0%) and early satiety (12.9%), respectively.

Patients with nausea (OR 0.26, 95% CI 0.12–0.57), vomiting (OR 0.34, 95% CI 0.15–0.80), early satiety (OR 0.41, 95% CI 0.17–0.97) were less likely to have ONS energy intake > 400 kcal/d than those without these symptoms after adjusting for the confounding factors. And other NIS were not associated with ONS energy intake > 400 kcal/d.

In this study, the incidence of NIS was 93.6%, and the highest was loss of appetite (43.8%), followed by nausea (18.8%), dysphagia (15.4%), vomiting (15.0%) and early satiety (12.9%), which is similar to previous studies.^5,29,30 These symptoms can lead to malnutrition and weight loss, with a potential risk of malabsorption.³¹ Studies have shown that loss of appetite had a great influence on dietary intake in HNC patients.^5,10 And radiation-related symptoms such as dysphagia and oral mucositis were positively associated with the rate of weight loss.¹⁰ Malnutrition was present in all patients in the study, with 72.1% assessed as severely malnourished. Thus, the patients need nutrition intervention urgently. And for patients with severe malnutrition, ONS is recommended for 2 weeks to several months after discharge.¹⁴

Patients with nausea or vomiting or early satiety were less likely to have ONS energy intake > 400 kcal/d than patients without these symptoms. Nausea, vomiting and early satiety belong to the gastrointestinal symptom cluster, and were found significantly correlated with the weight loss rate.¹⁰ These symptoms are closely related to chemotherapy. The drugs can arouse nausea and vomiting by stimulating the neural pathway related to gastrointestinal function through neurotransmitters (e.g., serotonin and substance P) or directly influencing the nerve center.³² And the two symptoms are interlinked with patients’ appetite and the feeling of fullness.³³ This study also showed that nausea had a greater impact on ONS energy intake than vomiting or early satiety. This is similar to the result of a recent cross-sectional study in China, which showed that patients tend to report that nausea makes them more miserable.³⁴ Management of these symptoms should consider comprehensive interventions, such as pharmacotherapy, medical nutrition therapy, and lifestyle interventions.³⁵ It is recommended to continuously review the nutritional status, NIS, body weight and dietary intake of HNC patients when they have insufficient dietary intake.³⁶ For HNC patients at a nutritional risk, measures should be taken to prevent or ameliorate NIS to reduce malnutrition caused by decreased nutrition intake.⁷

To the best of our knowledge, this is the first study to investigate the effect of NIS on ONS energy intake in HNC patients with malnutrition. However, this study also has some limitations. First, this is a retrospective, cross-sectional study, which can’t draw a causal inference. Second, the length of hospital stay and the interruption of nutritional intervention were not collected, which may be also the confounding factors. Third, the patients’ financial constraints may reduce the ability to use ONS,³⁷ which should be also included as a confounding factor in further study. Fourth, NIS were from the PG-SGA scale and didn’t include other Head and Neck symptoms, such as lack of energy, depression, difficulty chewing, thick saliva, and anxiety,⁶ which need to be considered in further study.

NIS is an important and convenient early warning indicator for malnutrition, which could affect the ONS energy intake. Active measures should be taken to alleviate the symptoms of nausea, vomiting, early satiety to improve nutrition intake.

Acknowledgements

We wish to thank the participants for taking part in the project.

Funding

This research was funded by Food Science and Technology Foundation of China Society of Food Science and Technology, Grant/Award Number: CAJJ-2-1.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Ethics Approval

The study protocol was approved by the ethics committee of West China Hospital, Sichuan University (No. 2019-725).

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of Data and Materials

The data sets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.

Author Contributions

T.D. and J.X. were involved in the design, literature review, data analysis, interpretation, and preparation of the manuscript. X.l., Z.W. and Wen Hu were involved in the concept, design and critical revision. All authors read and approved the final manuscript.

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Table 1. Basic characteristics of patients.

Independent variables		Total population
Independent variables		N=240
Age (Mean±SD)		51.4±15.7
Gender (n, %)	Male	106 (44.2%)
	Female	134 (55.8%)
BMI^a (n, %)	Underweight	79 (33.1%)
	Normal	121 (50.6%)
	Overweight	34 (14.2%)
	Obese	5 (2.1%)
Weight change in the last 2 weeks^b (n, %)	Decrease	155 (66.5%)
	Unchange	67 (28.8%)
	Increase	11 (4.7%)
Overall physical activity in last month^c (n, %)	Grade 1	62 (25.9%)
	Grade 2	116 (48.5%)
	Grade 3	35 (14.6%)
	Grade 4	20 (8.4%)
	Grade 5	6 (2.5%)
PG-SGA (n, %)	Stage B	67 (27.9%)
	Stage C	173 (72.1%)
ONS energy intake (kcal/d) (Median and IQR)		475 (365-524)
ONS energy intake (kcal/d) ＞400 (n, %)		157 (65.4%)
Treatment regimens (n, %)	Radiotherapy	23 (7.6)
	Chemotherapy	240 (79.7)
	Chemoradiotherapy	38 (12.6)
Tumor-related surgery history (n, %)	No	174 (72.5%)
	Yes	66 (27.5%)
Tumor recurrence or metastasis (n, %)	Primary tumor without metastasis	55 (22.9%)
	Recurrent	13 (5.4%)
	Primary tumor with metastasis	172 (71.7%)
aCCI (Mean±SD)		6.9±2.5
Smoking history (n, %)	Yes	46 (19.2%)
	No	194 (80.8%)
Drinking history (n, %)	Yes	39 (16.3%)
	No	201 (83.8%)
Neoplasm staging (n, %)	I	5 (2.1%)
	II	10 (4.2%)
	III	37 (15.4%)
	IV	129 (53.8%)
	Tumor not staging	59 (24.6%)

Note: ^amissing value 1; ^b missing value 7; ^c missing value 1

Table 2. Discription of NIS among the patients.

NIS		Total population
NIS		N=240
No dietary problem (n, %)	No	222 (92.5%)
	Yes	18 (7.5%)
No appetite, don’t want to eat (n, %)	No	135 (56.3%)
	Yes	105 (43.8%)
Nausea (n, %)	No	195 (81.3%)
	Yes	45 (18.8%)
Vomit (n, %)	No	204 (85.0%)
	Yes	36 (15.0%)
Constipation (n, %)	No	226 (94.2%)
	Yes	14 (5.8%)
Diarrhea (n, %)	No	233 (97.1%)
	Yes	7 (2.9%)
Dental ulcer (n, %)	No	221 (92.1%)
	Yes	19 (7.9%)
Orally dry (n, %)	No	238 (99.2%)
	Yes	2 (0.8%)
No taste or abnormal taste (n, %)	No	223 (92.9%)
	Yes	17 (7.1%)
Food odor interference (n, %)	No	228 (95.0%)
	Yes	12 (5.0%)
Dysphagia (n, %)	No	203 (84.6%)
	Yes	37 (15.4%)
Early satiety (n, %)	No	209 (87.1%)
	Yes	31 (12.9%)
Pain (n, %)	No	219 (91.3%)
	Yes	21 (8.8%)
Other (e.g., emotional low, money or tooth roblems) (n, %)	No	216 (90.0%)
	Yes	24 (10.0%)
Total scores of NIS (mean and SD)		3.2 (2.1)

Table 3. Logistic regression analyse of the association between the NIS and ONS energy intake.

		Model 1^a	Model 2^b
Independent variables		OR (95% CI)	OR (95% CI)
No dietary problem (%)	No	Reference	Reference
	Yes	1.93 (0.62–6.07)	1.06 (0.28–3.99)
No appetite, don’t want to eat (%)	No	Reference	Reference
	Yes	1.02 (0.60–1.75)	1.09 (0.58–2.04)
Nausea (%)	No	Reference	Reference
	Yes	0.30 (0.15–0.59)**	0.26 (0.12–0.57)**
Vomit (%)	No	Reference	Reference
	Yes	0.36 (0.17–0.74)**	0.34 (0.15–0.80)*
Constipation (%)	No	Reference	Reference
	Yes	1.34 (0.41–4.42)	1.13 (0.29–4.40)
Diarrhea (%)	No	Reference	Reference
	Yes	0.70 (0.15–3.19)	0.45 (0.08–2.60)
Dental ulcer (%)	No	Reference	Reference
	Yes	0.90 (0.34–2.38)	0.71 (0.24–2.13)
Orally dry (%)	No	Reference	Reference
	Yes	0.53 (0.03–8.51)	1.13 (0.06–21.70)
No taste or abnormal taste (%)	No	Reference	Reference
	Yes	0.57 (0.21–1.54)	0.53 (0.18–1.57)
Food odor interference (%)	No	Reference	Reference
	Yes	0.73 (0.22–2.37)	0.66 (0.18–2.37)
Dysphagia (%)	No	Reference	Reference
	Yes	1.78 (0.80–3.99)	1.54 (0.62–3.80)
Early satiety (%)	No	Reference	Reference
	Yes	0.51 (0.24–1.10)	0.41 (0.17–0.97)*
Pain (%)	No	Reference	Reference
	Yes	1.06 (0.41–2.75)	1.19 (0.41–3.45)
Other (e.g., emotional low, money or tooth roblems) (%)	No	Reference	Reference
	Yes	1.32 (0.52–3.32)	1.74 (0.54–5.58)

^a Model 1: unadjusted.

^b Model 2: adjusted for age, sex, BMI, weight change in the last 2 weeks, and physical activity in the last month and treatment regimens, tumor-related surgery history, tumor recurrence or metastasis, aCCI, smoking history, drinking history and neoplasm staging.

A total of 6 logistic regression models were used, two models for each exposure variable.

* P < 0.05, ** P < 0.01.

No competing interests reported.

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Effect of nutrition impact symptoms on oral nutritional supplements energy intake in head and neck cancer patients treated by chemotherapy: a retrospective, cross-sectional study

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Abstract

Background

Methods

Results

Conclusion

1 Background

2 Methods

2.1 Participants and Data Collection

2.2 Instruments

2.2.1 Exposure Variables: NIS

2.2.2 Outcome Variables: ONS energy intake

2.2.3 Covariates

2.3 Data Analysis

3 Results

4 Discussion

5 Conclusion

Declarations

References

Tables

Additional Declarations

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