Health TrialsbyHealthPanel

Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer

ConditionLocally Advanced Rectal Carcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Hull

About this trial

This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Have been diagnosed with locally advanced rectal cancer using MRI (Magnetic Resonance Imaging) and histological finding

Have been offered long-course neoadjuvant chemoradiotherapy in the Queens Centre, Castle Hill Hospital

Willing and able to comply with all study requirements

Disqualifiers

Inability to understand basic written and spoken English, as research materials will all be written in English.

Any movement deficiencies limiting ability to engage in exercise.

Impaired cognition and/or capacity limiting ability to provide informed consent.

Cardiovascular and/or cardiopulmonary conditions that will impede ability to safely perform exercise.

Trial design

Design model

Single group

Treatments tested in this trial

  • Supervised Vigorous intensity aerobic interval exercise

    Other intervention

    11-weeks course of aerobic and resistance exercise, delivered 2 weeks before long course NACRT, 5-weeks during NACRT and 4 weeks post NACRT. Alongside twice weekly unsupervised resistance exercise training.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single arm feasibilityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

The number of recruited participants/ total number of patients approached in percentage.

Time frame
This will be monitored in the total 6months of participants engagement if the study
2

Attendance rate

The number of supervised exercise sessions attended/ total number of available supervised exercise sessions in percentage.

Time frame
This will be monitored in the total 6months of participants engagement if the study
3

withdrawal rate

The number of participants who drop out of study/ total number of recruited participants in percentage.

Time frame
This will be monitored in the total 6months of participants engagement if the study

Secondary outcomes

1

Serum Carcinoembryonic antigen levels

measuring Serum Carcinoembryonic antigen levels

Time frame
up to 4 weeks before neoadjuvant chemoradiotherapy (NACRT), immediately following chemoradiotherapy and 6-months following NACRT
2

FACT-C version 4 questionnaire for Quality of life

measured using the FACT-C version 4 questionnaire

Time frame
up to 4 weeks before NACRT, up to 1 week post NACRT and 6-months following NACRT
3

EORTC-QLQ-CR29 questionnaire for Quality of life

measured using the EORTC-QLQ-CR29 questionnaire

Time frame
up to 4 weeks before NACRT, up to 1 week post NACRT and 6-months following NACRT
4

Physical activity levels

Using the 6-minute walk test

Time frame
up to 4 weeks before NACRT, up to 1 week post NACRT and 6-months following NACRT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hull

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov
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