Baseline clinical but not metabolic characteristics of cancer subjects dropping out of a clinical trial during chemotherapy are different from non-dropout subjects

Barbara S. van der Meij; Nicolaas E. Deutz; Ramon E. Rodriguez; Fari Koeman; Marielle P. Engelen

doi:10.1111/ajco.13089

Abstract

Aims: High attrition rate in clinical trials causes selection bias and reduces the validity of outcome data. Our aim was to identify metabolic and clinical characteristics of subjects who dropped out of a prospective nutrition trial during chemotherapy.

Methods: In 16 subjects with solid tumours undergoing chemotherapy, we assessed fasted whole body net protein breakdown (PB), myofibrillar PB (MPB) and Glycine (GLY) production rates by pulse IV administration of stable tracers: 2H3‐Leucine (LEU), [2H3]tau‐methylhistidine and 2H2‐GLY, prior to the start of a 10 week nutritional trial. Furthermore, we measured net protein synthesis (netPS) and protein digestion capacity (PD) after oral intake of a high‐protein meal with added [1‐13C]PHE and 15N‐spirulina, and primed continuous IV infusion of [ring‐2H5]PHE and [13C9‐15N]TYR. We assessed FFM‐i (DXA), muscle strength (handgrip‐, inspiratory‐, and leg), endurance, protein intake, physical activity, quality of life (EORTC‐QLQc30). Amino acid concentrations/enrichments by LC‐MS/MS, and statistics by unpaired t‐tests and spearman correlation tests.

Results: Seven subjects dropped out within 10 weeks of follow‐up. Fasted PB, MPB, GLY production rate, netPS after meal intake, PD, age, FFM‐i and muscle strength were comparable between dropout and non‐dropout subjects. Dropouts had a lower handgrip endurance (31.0 ± 9.2% vs 17.7 ± 12.9% strength lost, P = 0.005), protein intake (1.4 ± 0.7 vs 0.7 ± 0.4 g/kg/d, P = 0.06), physical activity (62.4 ± 53.0 vs 191.4 ± 92.6, P = 0.006) and global health status (46.4 ± 19.8 vs 74.1 ± 12.8, P = 0.004) and more appetite loss (52.4 ± 42.4 vs 11.1 ± 23.6, P = 0.03).

Conclusions: Subjects undergoing chemotherapy who drop out of a clinical trial report a lower dietary protein intake, physical activity, appetite and quality of life. This information can be valuable for future cancer trials to identify subjects with a high chance to drop out.

Original language	English
Article number	363
Pages (from-to)	172-172
Number of pages	1
Journal	Asia-Pacific Journal of Clinical Oncology
Volume	14
Issue number	S7
DOIs	https://doi.org/10.1111/ajco.13089
Publication status	Published - Nov 2018
Event	COSA's 45th Annual Scientific Meeting: Mesothelioma and Gastro‐Intestinal Cancers - Technology and Genomics - Perth Convention and Exhibition Centre, Perth, Australia Duration: 13 Nov 2018 → 15 Nov 2018 Conference number: 45th http://cosa2018.org/ http://www.cosa2018.org

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Oncology Nutrition Research
Isenring, E., Marshall, S., Van der Meij, B., Rigby, R., Teleni, L., Crichton, M. & Tang, X.
1/01/14 → …
Project: Research

1 Meeting Abstract

Early signs of impaired gut function in patients with advanced cancer undergoing chemotherapy
van der Meij, B. S., Deutz, N. E., Damink, S. O., Rodriguez, R. E. & Engelen, M. P., Nov 2018, In: Asia-Pacific Journal of Clinical Oncology. 14, S7, p. 172-172 1 p., 362.
Research output: Contribution to journal › Meeting Abstract › Research › peer-review

Open Access

Cite this

@article{ec946eddc3924af6acaf5b76f8568de6,

title = "Baseline clinical but not metabolic characteristics of cancer subjects dropping out of a clinical trial during chemotherapy are different from non-dropout subjects",

abstract = "Aims: High attrition rate in clinical trials causes selection bias and reduces the validity of outcome data. Our aim was to identify metabolic and clinical characteristics of subjects who dropped out of a prospective nutrition trial during chemotherapy.Methods: In 16 subjects with solid tumours undergoing chemotherapy, we assessed fasted whole body net protein breakdown (PB), myofibrillar PB (MPB) and Glycine (GLY) production rates by pulse IV administration of stable tracers: 2H3‐Leucine (LEU), [2H3]tau‐methylhistidine and 2H2‐GLY, prior to the start of a 10 week nutritional trial. Furthermore, we measured net protein synthesis (netPS) and protein digestion capacity (PD) after oral intake of a high‐protein meal with added [1‐13C]PHE and 15N‐spirulina, and primed continuous IV infusion of [ring‐2H5]PHE and [13C9‐15N]TYR. We assessed FFM‐i (DXA), muscle strength (handgrip‐, inspiratory‐, and leg), endurance, protein intake, physical activity, quality of life (EORTC‐QLQc30). Amino acid concentrations/enrichments by LC‐MS/MS, and statistics by unpaired t‐tests and spearman correlation tests.Results: Seven subjects dropped out within 10 weeks of follow‐up. Fasted PB, MPB, GLY production rate, netPS after meal intake, PD, age, FFM‐i and muscle strength were comparable between dropout and non‐dropout subjects. Dropouts had a lower handgrip endurance (31.0 ± 9.2% vs 17.7 ± 12.9% strength lost, P = 0.005), protein intake (1.4 ± 0.7 vs 0.7 ± 0.4 g/kg/d, P = 0.06), physical activity (62.4 ± 53.0 vs 191.4 ± 92.6, P = 0.006) and global health status (46.4 ± 19.8 vs 74.1 ± 12.8, P = 0.004) and more appetite loss (52.4 ± 42.4 vs 11.1 ± 23.6, P = 0.03).Conclusions: Subjects undergoing chemotherapy who drop out of a clinical trial report a lower dietary protein intake, physical activity, appetite and quality of life. This information can be valuable for future cancer trials to identify subjects with a high chance to drop out.",

author = "{van der Meij}, {Barbara S.} and Deutz, {Nicolaas E.} and Rodriguez, {Ramon E.} and Fari Koeman and Engelen, {Marielle P.}",

year = "2018",

month = nov,

doi = "10.1111/ajco.13089",

language = "English",

volume = "14",

pages = "172--172",

journal = "Asia-Pacific Journal of Clinical Oncology",

issn = "1743-7555",

publisher = "Wiley-Academy",

number = "S7",

note = "COSA's 45th Annual Scientific Meeting : Mesothelioma and Gastro‐Intestinal Cancers - Technology and Genomics, COSA ; Conference date: 13-11-2018 Through 15-11-2018",

url = "http://cosa2018.org/, http://www.cosa2018.org",

}

Baseline clinical but not metabolic characteristics of cancer subjects dropping out of a clinical trial during chemotherapy are different from non-dropout subjects. / van der Meij, Barbara S.; Deutz, Nicolaas E.; Rodriguez, Ramon E. et al.
In: Asia-Pacific Journal of Clinical Oncology, Vol. 14, No. S7, 363, 11.2018, p. 172-172.

Research output: Contribution to journal › Meeting Abstract › Research › peer-review

TY - JOUR

T1 - Baseline clinical but not metabolic characteristics of cancer subjects dropping out of a clinical trial during chemotherapy are different from non-dropout subjects

AU - van der Meij, Barbara S.

AU - Deutz, Nicolaas E.

AU - Rodriguez, Ramon E.

AU - Koeman, Fari

AU - Engelen, Marielle P.

N1 - Conference code: 45th

PY - 2018/11

Y1 - 2018/11

N2 - Aims: High attrition rate in clinical trials causes selection bias and reduces the validity of outcome data. Our aim was to identify metabolic and clinical characteristics of subjects who dropped out of a prospective nutrition trial during chemotherapy.Methods: In 16 subjects with solid tumours undergoing chemotherapy, we assessed fasted whole body net protein breakdown (PB), myofibrillar PB (MPB) and Glycine (GLY) production rates by pulse IV administration of stable tracers: 2H3‐Leucine (LEU), [2H3]tau‐methylhistidine and 2H2‐GLY, prior to the start of a 10 week nutritional trial. Furthermore, we measured net protein synthesis (netPS) and protein digestion capacity (PD) after oral intake of a high‐protein meal with added [1‐13C]PHE and 15N‐spirulina, and primed continuous IV infusion of [ring‐2H5]PHE and [13C9‐15N]TYR. We assessed FFM‐i (DXA), muscle strength (handgrip‐, inspiratory‐, and leg), endurance, protein intake, physical activity, quality of life (EORTC‐QLQc30). Amino acid concentrations/enrichments by LC‐MS/MS, and statistics by unpaired t‐tests and spearman correlation tests.Results: Seven subjects dropped out within 10 weeks of follow‐up. Fasted PB, MPB, GLY production rate, netPS after meal intake, PD, age, FFM‐i and muscle strength were comparable between dropout and non‐dropout subjects. Dropouts had a lower handgrip endurance (31.0 ± 9.2% vs 17.7 ± 12.9% strength lost, P = 0.005), protein intake (1.4 ± 0.7 vs 0.7 ± 0.4 g/kg/d, P = 0.06), physical activity (62.4 ± 53.0 vs 191.4 ± 92.6, P = 0.006) and global health status (46.4 ± 19.8 vs 74.1 ± 12.8, P = 0.004) and more appetite loss (52.4 ± 42.4 vs 11.1 ± 23.6, P = 0.03).Conclusions: Subjects undergoing chemotherapy who drop out of a clinical trial report a lower dietary protein intake, physical activity, appetite and quality of life. This information can be valuable for future cancer trials to identify subjects with a high chance to drop out.

AB - Aims: High attrition rate in clinical trials causes selection bias and reduces the validity of outcome data. Our aim was to identify metabolic and clinical characteristics of subjects who dropped out of a prospective nutrition trial during chemotherapy.Methods: In 16 subjects with solid tumours undergoing chemotherapy, we assessed fasted whole body net protein breakdown (PB), myofibrillar PB (MPB) and Glycine (GLY) production rates by pulse IV administration of stable tracers: 2H3‐Leucine (LEU), [2H3]tau‐methylhistidine and 2H2‐GLY, prior to the start of a 10 week nutritional trial. Furthermore, we measured net protein synthesis (netPS) and protein digestion capacity (PD) after oral intake of a high‐protein meal with added [1‐13C]PHE and 15N‐spirulina, and primed continuous IV infusion of [ring‐2H5]PHE and [13C9‐15N]TYR. We assessed FFM‐i (DXA), muscle strength (handgrip‐, inspiratory‐, and leg), endurance, protein intake, physical activity, quality of life (EORTC‐QLQc30). Amino acid concentrations/enrichments by LC‐MS/MS, and statistics by unpaired t‐tests and spearman correlation tests.Results: Seven subjects dropped out within 10 weeks of follow‐up. Fasted PB, MPB, GLY production rate, netPS after meal intake, PD, age, FFM‐i and muscle strength were comparable between dropout and non‐dropout subjects. Dropouts had a lower handgrip endurance (31.0 ± 9.2% vs 17.7 ± 12.9% strength lost, P = 0.005), protein intake (1.4 ± 0.7 vs 0.7 ± 0.4 g/kg/d, P = 0.06), physical activity (62.4 ± 53.0 vs 191.4 ± 92.6, P = 0.006) and global health status (46.4 ± 19.8 vs 74.1 ± 12.8, P = 0.004) and more appetite loss (52.4 ± 42.4 vs 11.1 ± 23.6, P = 0.03).Conclusions: Subjects undergoing chemotherapy who drop out of a clinical trial report a lower dietary protein intake, physical activity, appetite and quality of life. This information can be valuable for future cancer trials to identify subjects with a high chance to drop out.

U2 - 10.1111/ajco.13089

DO - 10.1111/ajco.13089

M3 - Meeting Abstract

SN - 1743-7555

VL - 14

SP - 172

EP - 172

JO - Asia-Pacific Journal of Clinical Oncology

JF - Asia-Pacific Journal of Clinical Oncology

IS - S7

M1 - 363

T2 - COSA's 45th Annual Scientific Meeting

Y2 - 13 November 2018 through 15 November 2018

ER -

Baseline clinical but not metabolic characteristics of cancer subjects dropping out of a clinical trial during chemotherapy are different from non-dropout subjects

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Early signs of impaired gut function in patients with advanced cancer undergoing chemotherapy

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