Introduction
Methods
Study Subjects
Gel-Based Saliva Substitute
The Test Meal
Study Setting
Sialometry
Data Analyses
Results
Study Subjects
Participating (n = 19) | Not participating (n = 17) | p value | |||
---|---|---|---|---|---|
Sex, n (%) | |||||
Male | 9 | (47) | 12 | (71) | 0.2 |
Female | 10 | (53) | 5 | (29) | |
Age, years | |||||
Median [range] | 60 | [46–80] | 66 | [49–80] | 0.7 |
Tumor location, n (%) | |||||
Larynx | 2 | (11) | 1 | (6) | 0.5 |
Pharynx | 16 | (84) | 13 | (76) | |
Oral cavity | 1 | (5) | 3 | (18) | |
Primary RT, n (%) | |||||
Curative intended | 19 | (100) | 16 | (94) | 0.5 |
Performance status, n (%) | |||||
0–1 | 19 | (100) | 12 | (71) | 0.04 |
≥ 2 | 0 | 5 | (29) | ||
Comorbidity, n (%) | |||||
No comorbidity | 4 | (21) | 6 | (35) | 0.5 |
≥ 1 comorbidity | 15 | (79) | 11 | (65) | |
Tumor stage, n (%) | |||||
Early | 7 | (37) | 2 | (12) | 0.1 |
Locally advanced | 12 | (63) | 15 | (88) | |
Months after RT | |||||
Median [range] | 19 | [6–50] | 23 | [0–39] | 0.5 |
RT dose, Gy | |||||
Median [range] | 66 | [66–68] | 66 | [66–76] | 0.5 |
Evaluation of the Gel-Based Saliva Substitute
Small food items | Test meal 1 | Test meal 2 | Test meal 3 | p value | |||
---|---|---|---|---|---|---|---|
M | (95% CI) | M | (95% CI) | M | (95% CI) | ||
Pureed (yoghurt) | |||||||
Does it hurt to swallow? | 9.95 | (9.84–10.06) | 9.89 | (9.74–10.05) | 9.89 | (9.67–10.12) | 0.87 |
Is it uncomfortable to swallow? | 8.84 | (7.47–10.22) | 9.05 | (7.86–10.25) | 9.32 | (8.20–10.43) | 0.85 |
Is it difficult to swallow? | 8.74 | (7.53–9.95) | 9.00 | (7.84–10.16) | 8.89 | (7.74–10.05) | 0.95 |
Does the food get stuck in your throat? | 7.58 | (5.98–9.18) | 8.63 | (7.46–9.80) | 8.63 | (7.42–9.85) | 0.41 |
Do you have to swallow multiple times? | 6.74 | (5.08–8.40) | 7.63 | (6.13–9.13) | 7.26 | (5.77–8.75) | 0.69 |
Do you cough while eating? | 9.47 | (8.37–10.58) | 10.0 | 9.32 | (8.31–10.32) | 0.47 | |
Minced (jelly bread) | |||||||
Does it hurt to swallow? | 9.72 | (9.35–10.10) | 9.82 | (9.55–10.10) | 9.83 | (9.48–10.18) | 0.52 |
Is it uncomfortable to swallow? | 7.89 | (6.26–9.52) | 8.88 | (7.99–9.77) | 8.72 | (7.63–9.81) | 0.39 |
Is it difficult to swallow? | 6.72 | (4.98–8.46) | 8.65 | (7.53–9.77) | 8.61 | (7.69–9.53) | 0.05* |
Does the food get stuck in your throat? | 6.67 | (4.93–8.41) | 8.47 | (7.38–9.56) | 8.50 | (7.68–9.32) | 0.05* |
Do you have to swallow multiple times? | 5.22 | (3.64–6.81) | 7.35 | (6.19–8.52) | 6.56 | (5.36–7.75) | 0.05* |
Do you cough while eating? | 9.89 | (9.65–10.12) | 9.88 | (9.71–10.05) | 9.44 | (8.76–10.13) | 0.23 |
Soft (white bread) | |||||||
Does it hurt to swallow? | 9.41 | (8.73–10.09) | 9.92 | (9.73–10.10) | 9.71 | (9.20–10.21) | 0.37 |
Is it uncomfortable to swallow? | 8.76 | (7.98–9.55) | 9.17 | (8.57–9.76) | 9.18 | (8.47–9.89) | 0.48 |
Is it difficult to swallow? | 7.47 | (6.12–8.82) | 9.08 | (8.39–9.77) | 8.65 | (7.74–9.55) | 0.07 |
Does the food get stuck in your throat? | 6.88 | (5.22–8.55) | 8.33 | (7.14–9.52) | 7.88 | (6.89–8.88) | 0.31 |
Do you have to swallow multiple times? | 5.06 | (3.31–6.81) | 7.42 | (5.67–9.16) | 6.59 | (5.37–7.81) | 0.21 |
Do you cough while eating? | 9.35 | (8.11–10.60) | 9.83 | (9.59–10.08) | 9.88 | (9.71–10.05) | 0.46 |
Regular (rye bread) | |||||||
Does it hurt to swallow? | 8.63 | (7.38–9.87) | 9.18 | (8.30–10.05) | 9.38 | (8.65–10.10) | 0.45 |
Is it uncomfortable to swallow? | 6.38 | (4.70–8.05) | 7.76 | (6.34–9.19) | 8.31 | (7.39–9.24) | 0.08 |
Is it difficult to swallow? | 5.38 | (3.63–7.12) | 7.41 | (6.43–8.39) | 7.94 | (6.94–8.94) | 0.008* |
Does the food get stuck in your throat? | 5.50 | (3.70–7.30) | 7.65 | (6.54–8.75) | 7.75 | (6.79–8.71) | 0.02* |
Do you have to swallow multiple times? | 4.00 | (2.44–5.56) | 6.00 | (4.69–7.31) | 5.81 | (4.69–6.93) | 0.05* |
Do you cough while eating? | 8.94 | (7.49–10.39) | 9.94 | (9.82–10.07) | 9.81 | (9.52–10.10) | 0.16 |
Regular (crisp bread) | |||||||
Does it hurt to swallow? | 8.75 | (7.38–10.12) | 8.64 | (6.98–10.30) | 9.00 | (7.63–10.37) | 0.93 |
Is it uncomfortable to swallow? | 6.94 | (5.25–8.63) | 7.29 | (5.48–9.09) | 7.06 | (5.38–8.74) | 0.96 |
Is it difficult to swallow? | 5.44 | (3.82–7.05) | 6.57 | (4.75–8.39) | 6.35 | (4.78–7.93) | 0.56 |
Does the food get stuck in your throat? | 6.44 | (4.89–7.98) | 6.43 | (4.68–8.18) | 7.00 | (5.62–8.38) | 0.81 |
Do you have to swallow multiple times? | 4.44 | (3.06–5.81) | 5.86 | (4.37–7.34) | 5.88 | (4.37–7.39) | 0.24 |
Do you cough while eating? | 9.69 | (9.15–10.23) | 9.00 | (7.60–10.40) | 9.71 | (9.27–10.14) | 0.37 |
Regular (meat) | |||||||
Does it hurt to swallow? | 9.06 | (8.14–9.98) | 9.00 | (7.78–10.22) | 9.41 | (8.62–10.21) | 0.79 |
Is it uncomfortable to swallow? | 6.63 | (5.20–8.05) | 7.25 | (5.56–8.94) | 6.47 | (4.64–8.30) | 0.76 |
Is it difficult to swallow? | 5.50 | (3.88–7.12) | 6.44 | (4.91–7.97) | 5.76 | (4.16–7.37) | 0.66 |
Does the food get stuck in your throat? | 5.75 | (3.95–7.55) | 6.06 | (4.46–7.66) | 6.41 | (4.91–7.91) | 0.83 |
Do you have to swallow multiple times? | 4.50 | (2.85–6.15) | 5.13 | (3.52–6.73) | 5.24 | (3.73–6.74) | 0.76 |
Do you cough while eating? | 9.75 | (9.44–10.06) | 9.38 | (8.18–10.57) | 8.94 | (7.59–10.30) | 0.53 |
Large food items | Test meal 1 | Test meal 2 | Test meal 3 | pvalue | |||
---|---|---|---|---|---|---|---|
M | (95% CI) | M | (95% CI) | M | (95% CI) | ||
Pureed (yoghurt) | |||||||
Does it hurt to swallow? | 9.89 | (9.73–10.05) | 9.59 | (8.96–10.22) | 9.79 | (9.35–10.23) | 0.61 |
Is it uncomfortable to swallow? | 9.06 | (8.08–10.03) | 9.29 | (8.45–10.14) | 9.05 | (7.89–10.22) | 0.92 |
Is it difficult to swallow? | 8.67 | (7.62–9.72) | 9.06 | (8.32–9.80) | 8.63 | (7.44–9.83) | 0.79 |
Does the food get stuck in your throat? | 8.50 | (7.49–9.51) | 9.06 | (8.30–9.82) | 8.58 | (7.38–9.77) | 0.69 |
Do you have to swallow multiple times? | 6.83 | (5.30–8.37) | 7.71 | (6.27–9.15) | 7.16 | (5.73–8.59) | 0.68 |
Do you cough while eating? | 9.28 | (8.10–10.46) | 10.0 | 9.42 | (8.43–10.42) | 0.48 | |
Minced (jelly bread) | |||||||
Does it hurt to swallow? | 9.60 | (9.14–10.06) | 9.93 | (9.77–10.08) | 9.76 | (9.38–10.15) | 0.43 |
Is it uncomfortable to swallow? | 8.07 | (6.54–9.60) | 9.07 | (8.24–9.90) | 8.06 | (6.81–9.31) | 0.40 |
Is it difficult to swallow? | 7.00 | (5.27–8.73) | 9.07 | (8.21–9.93) | 8.18 | (6.98–9.37) | 0.08 |
Does the food get stuck in your throat? | 6.73 | (5.07–8.40) | 8.36 | (7.19–9.53) | 7.65 | (6.39–8.91) | 0.23 |
Do you have to swallow multiple times? | 5.40 | (3.79–7.01) | 7.79 | (6.74–8.83) | 6.59 | (5.45–7.72) | 0.03* |
Do you cough while eating? | 9.87 | (9.67–10.06) | 9.93 | (9.77–10.08) | 9.47 | (8.84–10.10) | 0.22 |
Soft (white bread) | |||||||
Does it hurt to swallow? | 9.00 | (8.02–9.98) | 9.60 | (8.91–10.29) | 9.67 | (9.09–10.25) | 0.14 |
Is it uncomfortable to swallow? | 8.20 | (7.11–9.29) | 8.90 | (7.98–9.82) | 8.87 | (8.01–9.73) | 0.24 |
Is it difficult to swallow? | 6.87 | (5.26–8.47) | 8.50 | (7.27–9.73) | 8.40 | (7.38–9.42) | 0.06 |
Does the food get stuck in your throat? | 6.67 | (5.00–8.34) | 8.10 | (6.69–9.51) | 7.80 | (6.58–9.02) | 0.24 |
Do you have to swallow multiple times? | 4.47 | (2.90–6.03) | 7.40 | (5.61–9.19) | 6.80 | (5.73–7.87) | 0.004* |
Do you cough while eating? | 9.47 | (8.66–10.27) | 9.90 | (9.67–10.13) | 9.87 | (9.67–10.06) | 0.36 |
Regular (rye bread) | |||||||
Does it hurt to swallow? | 8.46 | (7.01–9.91) | 8.93 | (7.81–10.05) | 9.43 | (8.80–10.06) | 0.42 |
Is it uncomfortable to swallow? | 5.62 | (3.97–7.26) | 7.93 | (6.74–9.12) | 7.79 | (6.50–9.07) | 0.03* |
Is it difficult to swallow? | 4.23 | (2.75–5.71) | 7.07 | (5.88–8.26) | 6.71 | (5.42–8.00) | 0.004* |
Does the food get stuck in your throat? | 4.77 | (2.94–6.60) | 6.64 | (5.33–7.96) | 6.57 | (5.45–7.70) | 0.09 |
Do you have to swallow multiple times? | 3.77 | (2.33–5.21) | 6.50 | (5.22–7.78) | 6.14 | (5.08–7.20) | 0.004* |
Do you cough while eating? | 9.54 | (9.07–10.01) | 9.43 | (8.62–10.24) | 9.64 | (9.21–10.07) | 0.89 |
Regular (crisp bread) | |||||||
Does it hurt to swallow? | 8.31 | (6.28–10.33) | 8.07 | (6.30–9.85) | 8.71 | (7.07–10.35) | 0.86 |
Is it uncomfortable to swallow? | 6.23 | (4.22–8.24) | 7.00 | (5.17–8.83) | 6.93 | (5.35–8.51) | 0.77 |
Is it difficult to swallow? | 5.46 | (3.67–7.25) | 6.21 | (4.59–7.83) | 6.50 | (4.94–8.06) | 0.62 |
Does the food get stuck in your throat? | 4.77 | (2.75–6.79) | 6.00 | (4.40–7.60) | 6.43 | (4.85–8.01) | 0.33 |
Do you have to swallow multiple times? | 4.38 | (2.70–6.07) | 5.79 | (4.30–7.27) | 5.93 | (4.62–7.24) | 0.24 |
Do you cough while eating? | 9.46 | (8.78–10.14) | 8.43 | (6.55–10.31) | 9.57 | (9.03–10.11) | 0.29 |
Regular (meat) | |||||||
Does it hurt to swallow? | 7.45 | (5.16–9.75) | 8.17 | (6.05–10.28) | 8.62 | (6.95–10.28) | 0.67 |
Is it uncomfortable to swallow? | 5.36 | (3.23–7.49) | 6.83 | (4.64–9.03) | 6.54 | (4.51–8.57) | 0.55 |
Is it difficult to swallow? | 4.55 | (2.46–6.63) | 5.75 | (3.78–7.72) | 5.54 | (3.84–7.24) | 0.59 |
Does the food get stuck in your throat? | 5.18 | (2.78–7.58) | 5.75 | (3.70–7.80) | 5.31 | (3.47–7.14) | 0.91 |
Do you have to swallow multiple times? | 4.18 | (2.17–6.19) | 5.25 | (3.33–7.17) | 5.00 | (3.36–6.64) | 0.66 |
Do you cough while eating? | 9.36 | (8.35–10.37) | 8.92 | (7.28–10.55) | 8.62 | (7.34–9.89) | 0.69 |