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Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study

Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study
Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study
Abstract
Introduction Systemic anticancer therapy is given to selected patients with early breast cancer (EBC) before or after surgery with the aim of eradicating micrometastatic spread and reducing the risk of cancer recurrence. Chemotherapy treatment is most effective when patients receive the optimum dose, on time and without delays or reductions in their treatment doses. Most chemotherapy drugs are dosed according to body surface area calculated from a patient’s height and weight. These calculations were however designed based on data from normal weight patients. This has resulted in uncertainty as to the optimal dosing for patients with different amounts of blood, muscle and fatty tissue (body composition). This study uses segmental bioelectrical impedance analysis (using the Seca mBCA 515) to determine whether differences in the measures of resistance and reactance, and derived estimates of body composition, are predictive of chemotherapy toxicity in the treatment of EBC.

Methods and analysis A prospective observational cohort study of women with EBC in whom adjuvant or neoadjuvant chemotherapy is planned. A total of 300 participants will be recruited across nine UK hospital sites. The primary outcome is to determine if higher fat mass index is associated with increased National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 grade 3 (or higher) chemotherapy toxicity.

Ethics and dissemination This study has received ethical approval from the South Central Hampshire B Research Ethics Committee, England (19/SC/0596: IRAS: 263666). The chief investigator and coinvestigators will be responsible for publication of the study findings in a peer-reviewed journal, on behalf of all collaborators.

Trial registration number ISRCTN79577461.
breast tumours, chemotherapy, nutrition & dietetics, toxicity
2044-6055
Durkin, Kesta
3241256e-5543-4dda-9cd4-ab65e04b0dd6
Heetun, Mohammad, Adam
40ba9eee-8ec3-428e-9994-9baae9363864
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Munday, Richard
5595543c-3816-40a0-9d63-0b2a3594f55a
Wootton, Stephen
bf47ef35-0b33-4edb-a2b0-ceda5c475c0c
Turner, Lesley
5c548bd6-c6b6-4b24-8807-4674e987e390
Copson, Ellen
a94cdbd6-f6e2-429d-a7c0-462c7da0e92b
Cutress, Ramsey
68ae4f86-e8cf-411f-a335-cdba51797406
Durkin, Kesta
3241256e-5543-4dda-9cd4-ab65e04b0dd6
Heetun, Mohammad, Adam
40ba9eee-8ec3-428e-9994-9baae9363864
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Munday, Richard
5595543c-3816-40a0-9d63-0b2a3594f55a
Wootton, Stephen
bf47ef35-0b33-4edb-a2b0-ceda5c475c0c
Turner, Lesley
5c548bd6-c6b6-4b24-8807-4674e987e390
Copson, Ellen
a94cdbd6-f6e2-429d-a7c0-462c7da0e92b
Cutress, Ramsey
68ae4f86-e8cf-411f-a335-cdba51797406

Durkin, Kesta, Heetun, Mohammad, Adam, Ewings, Sean, Munday, Richard, Wootton, Stephen, Turner, Lesley, Copson, Ellen and Cutress, Ramsey (2022) Body composition and chemotherapy toxicity in women with early breast cancer (CANDO-3): protocol for an observational cohort study. BMJ Open, 12 (2), [e054412]. (doi:10.1136/bmjopen-2021-054412).

Record type: Article

Abstract

Abstract
Introduction Systemic anticancer therapy is given to selected patients with early breast cancer (EBC) before or after surgery with the aim of eradicating micrometastatic spread and reducing the risk of cancer recurrence. Chemotherapy treatment is most effective when patients receive the optimum dose, on time and without delays or reductions in their treatment doses. Most chemotherapy drugs are dosed according to body surface area calculated from a patient’s height and weight. These calculations were however designed based on data from normal weight patients. This has resulted in uncertainty as to the optimal dosing for patients with different amounts of blood, muscle and fatty tissue (body composition). This study uses segmental bioelectrical impedance analysis (using the Seca mBCA 515) to determine whether differences in the measures of resistance and reactance, and derived estimates of body composition, are predictive of chemotherapy toxicity in the treatment of EBC.

Methods and analysis A prospective observational cohort study of women with EBC in whom adjuvant or neoadjuvant chemotherapy is planned. A total of 300 participants will be recruited across nine UK hospital sites. The primary outcome is to determine if higher fat mass index is associated with increased National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 grade 3 (or higher) chemotherapy toxicity.

Ethics and dissemination This study has received ethical approval from the South Central Hampshire B Research Ethics Committee, England (19/SC/0596: IRAS: 263666). The chief investigator and coinvestigators will be responsible for publication of the study findings in a peer-reviewed journal, on behalf of all collaborators.

Trial registration number ISRCTN79577461.

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Durkin et al CANDO-3 BMJ open Feb2022
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More information

Accepted/In Press date: 26 January 2022
Published date: 22 February 2022
Keywords: breast tumours, chemotherapy, nutrition & dietetics, toxicity

Identifiers

Local EPrints ID: 456307
URI: http://eprints.soton.ac.uk/id/eprint/456307
ISSN: 2044-6055
PURE UUID: fcdfe69e-fcd8-4e91-a303-1de3ce6992f6
ORCID for Sean Ewings: ORCID iD orcid.org/0000-0001-7214-4917

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Date deposited: 27 Apr 2022 02:10
Last modified: 23 Jul 2022 02:00

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Contributors

Author: Kesta Durkin
Author: Mohammad, Adam Heetun
Author: Sean Ewings ORCID iD
Author: Richard Munday
Author: Stephen Wootton
Author: Lesley Turner
Author: Ellen Copson
Author: Ramsey Cutress

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