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RECRUITING Not applicable ClinicalTrials.gov

Chemo Brain Prehab Project

Sponsor: Dr. Chris Gaffney • ClinicalTrials.gov ID: NCT07341217

Registry updated: 2026-09-09
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Description

Colorectal cancer is 37% higher in the North West than the national average and is treated by chemotherapy, including fluorouracil, capecitabine, and oxaliplatin. A side effect of these drugs is loss of memory, forgetfulness, and general brain fog, which can persist for months after the end of treatment. These symptoms are collectively known as 'chemo-brain'. An existing prehabilitation intervention that has been previously developed will be used, which increases fitness and reduces hospital length of stay in colorectal cancer surgery patients, to try to improve the symptoms of chemo-brain in those undergoing chemotherapy and improve quality of life.

Interventions

  • Exercise Prehabilitation (Behavioral)
    The prehabilitation group will be asked to undertake a remote exercise programme. The home-based exercise sessions will take place four times per week. Two will be unsupervised exercise sessions, and the other two will be online supervised exercise sessions. Each session will last for approximately 40 minutes for a minimum of 3 weeks, a maximum of 4 weeks. Exercise tolerance will be built up from 2 supervised sessions (week 1) up to the recommended four sessions per week (week 3/4). The number of sessions will be sustained throughout chemotherapy until the end of chemotherapy (visit 3). The participants will be remotely supervised by a qualified exercise instructor. They will have a combination of aerobic and resistance exercise within each session. It will be individualised and tailored to their physical abilities. The exercises will target their upper body (arms and shoulders) and legs. Exercise programmes, videos, and links to supervised sessions will be provided.
  • Multivitamins (Dietary supplement)
    Multivitamins will be given following the first testing visit until the third visit (following the last chemotherapy round). The multivitamins will be taken daily before and during chemotherapy. The multivitamin supplement contains a combination of 24 essential vitamins (vitamin A, D2, B1, B2, B6, B12, C, E, Biotin, nicotinamide, pantothenic acid and folic acid), minerals and trace elements (calcium, iron, copper, phosphorus, magnesium, potassium, zinc, iodine, manganese, selenium, chromium, and molybdenum). Each multivitamin and mineral plays a vital role in the efficient daily maintenance of many body processes.
  • Standard Care (in control arm) (Other)
    Participants with colorectal cancer will receive chemotherapy treatment.

Eligibility criteria

Inclusion Criteria: * Individuals with stage II or III colorectal cancer undergoing chemotherapy with fluorouracil, capecitabine, or oxaliplatin. * Aged 60-85 years old. * Fluent in English * Male and female participants * Not engaged in structured exercise training\* within the six months before providing consent. Exclusion Criteria: * Presence of comorbidities that may significantly alter the metabolic response to exercise (e.g., diabetes mellitus). * Any contraindication to the multivitamin supplementation (Forceval), including known hypercalcaemia, haemochromatosis, peanut or soya allergy, current use of phenytoin or tetracycline antibiotics, and clinically significant impaired renal or hepatic function. * Evidence of pre-existing cognitive impairment, including diagnosis of dementia, other neurodegenerative disorders (e.g., Alzheimer's disease), or clinically indicated mild cognitive impairment. * Diagnosis of atrial fibrillation and haematological malignancy. * Participants without home internet access will be excluded due to the online delivery of the exercise programme. * Diagnosis of profound hearing loss. * Receiving palliative care. * Presence of synchronous cancer. * Structured exercise refers to planned and organised physical activity, such as gym workouts, exercise classes or a team sport, which are designed to improve or maintain physical fitness, often with instruction, rules, and goals.

Conditions

Colorectal Cancer Older Adults (60 - 85 Years Old) Physically Inactive Chemotherapy

Locations

  • East Lancashire Teaching Hospitals NHS Trust — Blackburn, Lancashire, United Kingdom
  • University Hospitals Morecambe Bay Trust, Royal Lancaster Infirmary — Lancaster, Lancashire, United Kingdom
  • Lancashire Teaching Hospitals NHS Trust — Preston, Lancashire, United Kingdom
  • The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record