Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.

Oesophageal Adenocarcinoma Clinical Trial

— Oeso-Chemo  

Official title:

Effect of Neoadjuvant Chemotherapy on Muscle Mass and Peri-operative Cardiorespiratory Performance in Patients Undergoing Oesophageal Cancer- a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742312
• Other study ID #: 10/H0405/38
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: February 17, 2016
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.

Description:

We aim to review the effects of chemotherapy on skeletal muscle mass and cardio-respiratory performance in patients with oesophageal adenocarcinoma. All patients will be assessed by a Consultant Anaesthetist and a medical member of the Research team before commencing chemotherapy and after finishing their course. These assessments include a nutritional assessment, performance status assessments, blood assays, dual energy X-ray absorptiometry (DEXA) scans, cardio-pulmonary exercise (CPEX) testing and a muscle biopsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• oesophageal cancer

• Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery

Exclusion Criteria:

• Metastatic disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Oesophageal Adenocarcinoma

Intervention

Radiation:
• DEXA scan
all patients will undertake a full body DEXA scan before and after chemotherapy

Procedure:
• Muscle biopsy
All patients will have a muscle biopsy before and after chemotherapy

Other:
• cardio-pulmonary exercise testing (CPEX)
patients will undertake exercise in the form of an exercise bike whilst having their cardiac and ventilatory performance analysed. This will take place before and after neoadjuvant chemotherapy

Locations

Country	Name	City	State
United Kingdom	Graduate Entry Medical School, University of Nottingham	Derby	Derbyshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Derby Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle mass	variations in muscle mass during neoadjuvant chemotherapy	3 months	No
Secondary	nutritional status	assess nutritional status post chemotherapy via serum protein levels.	3 months	No
Secondary	all cause mortality	Evidence of mortality and relate this to aerobic ability.	3 months	No
Secondary	mitochondrial function performance status	review changes in mitochondrial function after neoadjuvant chemotherapy	3 months	No
Secondary	cardiorespiratory performance (peak VO2)	review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy	3 months	No