Magnesium hydroxide versus macrogol/electrolytes in the prevention of opioid-induced constipation in incurable cancer patients: study protocol for an open-label, randomized controlled trial (the OMAMA study)

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Abstract

Background

Opioid-induced constipation (OIC) is a common symptom in cancer patients treated with opioids with a prevalence of up to 59%. International guidelines recommend standard laxatives such as macrogol/electrolytes and magnesium hydroxide to prevent OIC, although evidence from randomized controlled trials is largely lacking. The aim of our study is to compare magnesium hydroxide with macrogol /electrolytes in the prevention of OIC in patients with incurable cancer and to compare side-effects, tolerability and cost-effectiveness.

Methods

Our study is an open-label, randomized, multicenter study to examine if magnesium hydroxide is non-inferior to macrogol/electrolytes in the prevention of OIC. In total, 330 patients with incurable cancer, starting with opioids for pain management, will be randomized to treatment with either macrogol/electrolytes or magnesium hydroxide. The primary outcome measure is the proportion of patients with a score of < 30 on the Bowel Function Index (BFI), measured on day 14.

The Rome IV criteria for constipation, side effects of and satisfaction with laxatives, pain scores, quality of life (using the EQ-5D-5L), daily use of laxatives and escape medication, and cost-effectiveness will also be assessed.

Discussion

In this study we aim to examine if magnesium hydroxide is non-inferior to macrogol/electrolytes in the prevention of OIC. The outcome of our study will contribute to prevention of OIC and scientific evidence of guidelines on (opioid-induced) constipation.

Trial registration

This trial is registered at clinicaltrials.gov: NCT05216328 and in the Dutch trial register: NTR80508. EudraCT number 2022–000408-36.

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Most cited references 44

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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

(2013)

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Good and poor adherence: optimal cut-point for adherence measures using administrative claims data.

Sudeep Karve, B. Martin, T Hudson … (2009)

To identify the adherence value cut-off point that optimally stratifies good versus poor compliers using administratively derived adherence measures, the medication possession ratio (MPR) and the proportion of days covered (PDC) using hospitalization episode as the primary outcome among Medicaid eligible persons diagnosed with schizophrenia, diabetes, hypertension, congestive heart failure (CHF), or hyperlipidemia. This was a retrospective analysis of Arkansas Medicaid administrative claims data. Patients > or =18 years old had to have at least one ICD-9-CM code for the study diseases during the recruitment period July 2000 through April 2004 and be continuously eligible for 6 months prior and 24 months after their first prescription for the target condition. Adherence rates to disease-specific drug therapy were assessed during 1 year using MPR and PDC. MAIN OUTCOME MEASURE AND ANALYSIS SCHEME: The primary outcome measure was any-cause and disease-related hospitalization. Univariate logistic regression models were used to predict hospitalizations. The optimum adherence value was based on the adherence value that corresponded to the upper most left point of the ROC curve corresponding to the maximum specificity and sensitivity. The optimal cut-off adherence value for the MPR and PDC in predicting any-cause hospitalization varied between 0.63 and 0.89 across the five cohorts. In predicting disease-specific hospitalization across the five cohorts, the optimal cut-off adherence values ranged from 0.58 to 0.85. This study provided an initial empirical basis for selecting 0.80 as a reasonable cut-off point that stratifies adherent and non-adherent patients based on predicting subsequent hospitalization across several highly prevalent chronic diseases. This cut-off point has been widely used in previous research and our findings suggest that it may be valid in these conditions; it is based on a single outcome measure, and additional research using these methods to identify adherence thresholds using other outcome metrics such as laboratory or physiologic measures, which may be more strongly related to adherence, is warranted.

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Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire.

Dominique Dubois, Patrick Marquis, Olivier Chassany … (2005)

Chronic constipation is characterized by difficult, infrequent, or seemingly incomplete bowel movements. The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire was developed to address the need for a standardized, patient-reported outcomes measure to evaluate constipation over time. Items for the PAC-QOL were generated from the literature, clinical experts, and patients. Following principal components and multi-trait analyses, 28 items were retained forming four subscales (worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction) and an overall scale. Validation studies were conducted in the United States, Europe, Canada, and Australia, to evaluate the internal consistency reliability (Cronbach's alpha), reproducibility (Intraclass Correlation Coefficients (ICCs)), validity (analysis of variance models), and responsiveness (effect size) of the PAC-QOL scales. The PAC-QOL scales were internally consistent (Cronbach's alpha >0.80) and reproducible (ICCs >0.70, except for the satisfaction subscale ICC=0.66). PAC-QOL scale scores were significantly associated with abdominal pain (p<0.001) and constipation severity (p<0.05). Effect sizes in patients reporting improvements in constipation over a 6-week period were moderate to large, with subscale effect sizes ranging from 0.76 to 3.41 and the overall scale effect size=1.77. Similar findings were observed in validation studies conducted in Europe, Canada, and Australia. The PAC-QOL is a brief but comprehensive assessment of the burden of constipation on patients' everyday functioning and well-being. Multinational studies demonstrate that the PAC-QOL is internally consistent, reproducible, valid, and responsive to improvements over time.

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Author and article information

Contributors

K.R.J. Kistemaker: k.kistemaker@amsterdamumc.nl

Journal

Journal ID (nlm-ta): BMC Palliat Care

Journal ID (iso-abbrev): BMC Palliat Care

Title: BMC Palliative Care

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-684X

Publication date (Electronic): 14 March 2023

Publication date PMC-release: 14 March 2023

Publication date Collection: 2023

Volume: 22

Electronic Location Identifier: 22

Affiliations

[1 ]GRID grid.509540.d, ISNI 0000 0004 6880 3010, Amsterdam UMC Location Vrije Universiteit Amsterdam, Medical Oncology, ; De Boelelaan 1117, Amsterdam, The Netherlands

[2 ]GRID grid.509540.d, ISNI 0000 0004 6880 3010, Amsterdam UMC Location Vrije Universiteit Amsterdam, Anesthesiology, ; De Boelelaan 1117, Amsterdam, The Netherlands

[3 ]GRID grid.16872.3a, ISNI 0000 0004 0435 165X, Cancer Center Amsterdam, Treatment and Quality of Life, ; Amsterdam, The Netherlands

[4 ]GRID grid.7692.a, ISNI 0000000090126352, Department of Medical Oncology, , University Medical Center Utrecht, Utrecht, Academic Hospice Demeter, ; De Bilt, The Netherlands

[5 ]GRID grid.509540.d, ISNI 0000 0004 6880 3010, Amsterdam UMC Location Vrije Universiteit Amsterdam, Clinical Pharmacology and Pharmacy, ; De Boelelaan 1117, Amsterdam, The Netherlands

[6 ]GRID grid.416219.9, ISNI 0000 0004 0568 6419, Spaarne Gasthuis Location Hoofddorp, Medical Oncology, ; Spaarnepoort 1, Hoofddorp, The Netherlands

[7 ]GRID grid.7692.a, ISNI 0000000090126352, Department of Data Science and Biostatistics, , University Medical Center Utrecht, ; Utrecht, The Netherlands

[8 ]GRID grid.7692.a, ISNI 0000000090126352, Department of Epidemiology and Health Economics, , University Medical Center Utrecht, ; Utrecht, The Netherlands

Article

Publisher ID: 1143

DOI: 10.1186/s12904-023-01143-2

PMC ID: 10012532

PubMed ID: 36915062

SO-VID: 8b9ff93b-101b-4dc6-8ac4-c33c650f5ecb

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 24 February 2023

Date accepted : 8 March 2023

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001826, ZonMw;

Award ID: 08440012010002

Award Recipient : K.R.J. Kistemaker A. de Graeff M. Crul G. de Klerk P.M. van de Ven M.P. van der Meulen L. van Zuylen M.A.H. Steegers

Custom metadata

ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: opioids,constipation,magnesium hydroxide,macrogol/electrolytes,laxative,cancer,palliative care,clinical trial

Data availability:

ScienceOpen disciplines: Anesthesiology & Pain management

Keywords: opioids, constipation, magnesium hydroxide, macrogol/electrolytes, laxative, cancer, palliative care, clinical trial

Magnesium hydroxide versus macrogol/electrolytes in the prevention of opioid-induced constipation in incurable cancer patients: study protocol for an open-label, randomized controlled trial (the OMAMA study)

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Abstract

Background

Methods

Discussion

Trial registration

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Irish Journal of Paramedicine

Most cited references 44

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

Good and poor adherence: optimal cut-point for adherence measures using administrative claims data.

Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire.

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Contributors

Journal

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Article

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