Esophageal CancerNCT03061370
Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer
An observational study of Esophageal Cancer and Gastric Cancer, run by St. James's Hospital, Ireland at 2 sites in Ireland.
Trial summary
In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Sarcopenia
- What is being tested?
- Esophagectomy or Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 317 participants
- Where
- 2 sitesIreland
- Study dates
- 1 Jan 2010to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Esophageal or gastric cancer between 2010 and 2016
Who may be able to join
- Initial staging computed tomography (CT) scan capturing the level of the L3 conducted at our Centre and available for review
Who cannot join
- Patients who had a history of previous gastrointestinal resection, other active malignancy, eating disorder, inflammatory bowel disease or other significant illness that might alter body composition were excluded from analysis.
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Department of Surgery, St. James's Hospital
Dublin, D4
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, D8
About this study
Official title: An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies
In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy.
The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible.
The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.
- Conditions
- Esophageal Cancer, Gastric Cancer, Sarcopenia, Sarcopenic Obesity, Obesity, Visceral Obesity
- Being tested
- Esophagectomy or Gastrectomy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Sarcopenia, Obesity, Obesity, Abdominal, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagectomy or GastrectomyProcedure or surgery
Surgical resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Neoadjuvant therapy toxicity
Measured: 6 months
Postoperative morbidity
Measured: 6 months
Oncologic outcome
Measured: 6 months
Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jan 2010
- Primary completion1 Jan 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jessie A Elliott, St. James's Hospital, Ireland
- Investigators
- John V Reynolds, MCh FRCS, Principal investigator, Department of Surgery, St. James's Hospital, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061370
- Sponsor's protocol ID
- SJHDOS2016-01
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.
PubMed 18539529Doyle SL, Bennett AM, Donohoe CL, Mongan AM, Howard JM, Lithander FE, Pidgeon GP, Reynolds JV, Lysaght J. Establishing computed tomography-defined visceral fat area thresholds for use in obesity-related cancer research. Nutr Res. 2013 Mar;33(3):171-9. doi: 10.1016/j.nutres.2012.12.007. Epub 2013 Jan 30.
PubMed 23507222Elliott JA, Doyle SL, Murphy CF, King S, Guinan EM, Beddy P, Ravi N, Reynolds JV. Sarcopenia: Prevalence, and Impact on Operative and Oncologic Outcomes in the Multimodal Management of Locally Advanced Esophageal Cancer. Ann Surg. 2017 Nov;266(5):822-830. doi: 10.1097/SLA.0000000000002398.
PubMed 28796017
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT03061370
- Acronym / sponsor ID
- SJHDOS2016-01
- Conditions
- Esophageal Cancer, Gastric Cancer, Sarcopenia, Sarcopenic Obesity, Obesity, Visceral Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy.
The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible.
The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Esophageal or gastric cancer between 2010 and 2016
Key inclusion criteria (1 listed)
- Initial staging computed tomography (CT) scan capturing the level of the L3 conducted at our Centre and available for review
Key exclusion criteria (1 listed)
- Patients who had a history of previous gastrointestinal resection, other active malignancy, eating disorder, inflammatory bowel disease or other significant illness that might alter body composition were excluded from analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagectomy or GastrectomySurgical resection | Procedure or surgery | – |
Primary outcome
Neoadjuvant therapy toxicity
Time frame: 6 months
Postoperative morbidity
Time frame: 6 months
Oncologic outcome
Time frame: 6 months
Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 18539529Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6.
- Background: PubMed 23507222Doyle SL, Bennett AM, Donohoe CL, Mongan AM, Howard JM, Lithander FE, Pidgeon GP, Reynolds JV, Lysaght J. Establishing computed tomography-defined visceral fat area thresholds for use in obesity-related cancer research. Nutr Res. 2013 Mar;33(3):171-9. doi: 10.1016/j.nutres.2012.12.007. Epub 2013 Jan 30.
- Results publication: PubMed 28796017Elliott JA, Doyle SL, Murphy CF, King S, Guinan EM, Beddy P, Ravi N, Reynolds JV. Sarcopenia: Prevalence, and Impact on Operative and Oncologic Outcomes in the Multimodal Management of Locally Advanced Esophageal Cancer. Ann Surg. 2017 Nov;266(5):822-830. doi: 10.1097/SLA.0000000000002398.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John V Reynolds, MCh FRCS principal investigator
Department of Surgery, St. James's Hospital, Dublin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastric Cancer, run by St. James's Hospital, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neoadjuvant therapy toxicity (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061370, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.