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 P Deutz, Ramon E. Rodriguez, Fari Koeman, Marielle Pkj Engelen

Research output: Contribution to journalMeeting AbstractResearchpeer-review

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 languageEnglish
Article number363
Pages (from-to)172
Number of pages1
JournalAsia-Pacific Journal of Clinical Oncology
Volume14
Issue numberS7
DOIs
Publication statusPublished - Nov 2018

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Clinical Trials
Drug Therapy
Neoplasms
Proteins
Glycine
Muscle Strength
Appetite
Proteolysis
Meals
Quality of Life
Methylhistidines
Spirulina
Dietary Proteins
Selection Bias
Leucine
Health Status
Leg
Heart Rate
Amino Acids

Cite this

@article{28fe4e87898d4acaadb1bfed90fd81df,
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 P} and Rodriguez, {Ramon E.} and Fari Koeman and Engelen, {Marielle Pkj}",
year = "2018",
month = "11",
doi = "10.1111/ajco.13089",
language = "English",
volume = "14",
pages = "172",
journal = "Asia-Pacific Journal of Clinical Oncology",
issn = "1743-7555",
publisher = "Wiley-Academy",
number = "S7",

}

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 P; Rodriguez, Ramon E.; Koeman, Fari; Engelen, Marielle Pkj.

In: Asia-Pacific Journal of Clinical Oncology, Vol. 14, No. S7, 363, 11.2018, p. 172.

Research output: Contribution to journalMeeting AbstractResearchpeer-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 P

AU - Rodriguez, Ramon E.

AU - Koeman, Fari

AU - Engelen, Marielle Pkj

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

VL - 14

SP - 172

JO - Asia-Pacific Journal of Clinical Oncology

JF - Asia-Pacific Journal of Clinical Oncology

SN - 1743-7555

IS - S7

M1 - 363

ER -