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Completed

NCT Number: NCT04880772

Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery

To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery

Completed

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Blackburn Hospital

Blackburn, BB@ 3HH, United Kingdom

About this study

Preliminary qualitative and quantitative studies suggest that there are benefits (reduced length of stay, improved cardiorespiratory function, reduced postoperative complications and improved quality of life) when prehabilitation is used with the context of cancer care. In 2017 Macmillian Cancer Support developed a strategic 'Evidence and Insight' review on prehabilitation. The outcome of this was to incorporate prehabilitation into routine cancer care and to develop principles and guidance for prehabilitation. This study aims to support this vision and answer some of the questions on the patients who are most likely to benefit from prehabilitation and to quantify some of these benefits by investigating the molecular processes that influence clinical changes

This study primarily seeks to assess the cardiovascular and biological impact of prehabilitation (exercise, nutrition) on patients undergoing hepatobiliary and colorectal cancer surgery. The investigators aim to assess whether there is an improvement in various cardiopulmonary exercise testing (CPET) variables such as maximum oxygen consumption and anaerobic threshold. The investigators also aim to study the inflammatory cytokines associated with cancer and how these markers respond to exercise. These inflammatory markers are thought to play a role in influencing some clinical outcomes such as wound infection and recovery.

The study will also assess secondary outcomes including hospital stay, post operative complications and quality of life. The investigators aim to better understand the biological relationship between anti-inflammatory cytokine levels and the previously mentioned outcomes by measuring and analysing these mediators and performing selected muscle biopsies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-85
  • Sex: male/female
  • Radiological/tissue cancer diagnosis
  • Curative cancer of the colon, rectum, colorectal liver metastases (CRLM) of 2 or more segments
  • elective surgery (planned a minimum of 3 weeks from the date of first clinic meeting)
  • Access to digital technology(mobile phone, tablet or laptop, home computer) to participate in supervised home exercise

Exclusion criteria

Exclusion

  • Palliative disease
  • Haematological malignancy
  • Pregnancy
  • Emergency surgery
  • Physically unable to undergo CPET
  • Part of any other trial with similar interventions unless previously agreed on with all CIs
  • synchronous disease (operation on HPB & colorectal cancers at the same operation)
  • No access to digital technology(smart phone, tablet, laptop or home computer)

Treatment and study plan

Prehabilitation

Other

exercise & multivitamin (nutritional/dietary advice)

Primary outcomes

  1. Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min

    Time frame: change in baseline AT & VO2 peak at 4 weeks

    Cardiopulmonary exercise Test (CPET) variables

  2. Inflammatory cytokines

    Time frame: change in baseline cytokines at 4 weeks

    IL6 IL10 in muscle and blood measured in pg/ml

Secondary outcomes

  1. Clavien-Dindo complication rates

    Time frame: Up to 30 days from the day of operation

    Grades I-IV

  2. Length of hospital stay measured in days

    Time frame: 30 & 90-day mortality

    Defined as duration of stay from date of operation to discharge

  3. Quality of life measures (Illness Perception Questionnaire)

    Time frame: baseline and within 24 weeks after surgery

    This questionnaire assesses perceptions on each of the five dimensions(Identity, Cause, Timeline, Consequences, Cure-Control) by asking patients for their own beliefs about their condition.

    High scores on the identity, consequences, timeline acute/ chronic and cyclical subscales represent strongly held beliefs about the number of symptoms attributed, the negative consequences, and the chronicity and cyclical nature of the illness.

    High scores on the identity and cure-control and coherence subscales represent positive beliefs about controllability and a personal understanding of the illness.

  4. Hand Grip Strength measured in kg

    Time frame: baseline, immediately after the intervention, within 24 weeks after surgery

    Measured by digital dynamometer

  5. Quality of life measure (Mental Adjustment to Cancer Scale)

    Time frame: baseline and within 24 weeks after surgery

    Assessment of participants mental adjustment to a cancer diagnosis. Designed to measure Fighting Spirit (FS), Anxious Preoccupation (AP), Helpless-hopelessness (HH) and Fatalism. This is a 40-item measure of specific psychological (Coping) responses that cancer patients may display in the process of adjusting to the diagnosis and treatment of their disease.

    A higher score represents higher endorsement of the adjustment response.

Sponsors and collaborators

Lead sponsor

East Lancashire Hospitals NHS Trust

Other

Collaborators

  • Lancaster University

Registry information

Official study title

A Single-centre Two-armed Randomised Controlled Trial Comparing Standard Care Alone Versus Exercise and Nutrition Prehabilitation in Elective Patients Undergoing Resectional HPB and Colorectal Cancer Surgery

Acronym: SPECS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 11, 2021
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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