Chemo Brain Prehab Project

NCT07341217 | Not Yet Recruiting

• 2 other identifiers: 25/EM/0250AR2024.07
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

Cancer; Colorectal Cancer; Prehabilitation; Exercise; Brain Health; Chemo-brain; Chemotherapy; Cognitive Function

Outcome Measures

Primary Outcomes (5)

• Blood-based markers

  Use physiological blood-based markers to establish if prehabilitation promotes an improvement in brain health in colorectal cancer patients before starting chemotherapy. Brain-Derived Neurotrophic Factor (BDNF) and Vascular Endothelial Growth Factor (VEGF).

  Blood-based markers will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).

• Change in brain activity during the Flanker Inhibitory Control and Attention Test

  Cognitive function and its neural correlates will be assessed while participants complete the NIH Toolbox Flanker Inhibitory Control and Attention Test during electroencephalography (EEG) recording. This test assesses inhibitory control and attention by requiring participants to focus on a central target (fish or arrows) and identify its direction while ignoring distracting "flanker" stimuli pointing in a different direction, using a scoring algorithm combining accuracy and reaction time for a cognitive score. Flanker raw scores (0-10) will be converted to age-corrected standard scores (mean 100, standard deviation (SD) 15), with higher scores indicating better cognitive performance. Age-standardised Flanker scores and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.

  Data from the Flanker Inhibitory Control and Attention Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).

• Change in brain activity during the List Sorting Working Memory Test

  Cognitive function and its neural correlates will be assessed while participants complete the NIH Toolbox List Sorting Working Memory Test during electroencephalography (EEG) recording. The test assesses working memory by having individuals recall and sequence visually presented items (such as food and animal pictures) in order of size (smallest to largest) after they disappear. Performance is based on correctly sequenced items. The list sorting raw scores (0-10) will be converted to age-corrected standard scores (mean 100, standard deviation (SD) 15), with higher scores indicating better cognitive performance. Age-standardised list sorting scores and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.

  Data from the List Sorting Working Memory Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).

• Change in brain activity during the Oral Symbol Digit Test

  Cognitive function and its neural correlates will be assessed while participants complete the NIH Toolbox Oral Symbol Digit Test during electroencephalography (EEG) recording. This test is a brief, computerised measure of processing speed, where participants orally match symbols to numbers from a key (1-9) presented on an iPad for 120 seconds, scoring how many correct matches they make sequentially to assess rapid visual information processing. The oral symbol digit raw scores (0-10) will be converted to age-corrected standard scores (mean 100, standard deviation (SD) 15), with higher scores indicating better cognitive performance. Age-standardised oral symbol digit test scores and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.

  Data from the Oral Symbol Digit Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).

• Changes in brain activity during the Words-In-Noise Test

  Audition and its neural correlates will be assessed while participants complete the NIH Toolbox Words-In-Noise Test during electroencephalography (EEG) recording. The test assesses a person's ability to understand spoken words amidst varying levels of background noise. The test is scored by determining the signal-to-noise ratio (SNR) at which a person correctly repeats 50% of the words, called the SNR50, calculated using the Spearman-Kärber equation. Lower SNR50 values (in dB) indicate better hearing in noise, and higher SNR50 values indicate poorer performance. Participants will be classified as having adequate hearing in noise if their SNR50 is ≤ 6 dB. The SNR50 and task-related EEG measures (spectral power ratios and event-related potentials) will be compared across visits 1-3 within participants and between intervention and control groups to examine changes in cognitive performance and associated brain activity.

  Data from the Words-In-Noise Test will be collected at three visits: baseline (visit 1), 72 hours before the start of chemotherapy (visit 2) and 72 hours after the final dose of chemotherapy has been received (visit 3).

Secondary Outcomes (1)

• Change in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) total score

  The cognitive-related quality of life scores (FACT-Cog) will be collected at three visits: baseline (visit 1) and three months following the final round of chemotherapy.

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

This group will receive the exercise programme before and during chemotherapy (4 times per week; 2 supervised online home-based sessions and 2 unsupervised home-based sessions), with the addition of daily multivitamins and behavioural support via a weekly telephone check-up.

Behavioral: Exercise Prehabilitation; Dietary Supplement: Multivitamins; Other: Standard Care (in control arm)

Standard Care Group

OTHER

This group will receive their treatment as planned as part of standard care, but will not receive the prehabilitation (exercise, nutrition, and behavioural support).

Other: Standard Care (in control arm)

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.

Also known as: Exercise programme, exercise intervention

Prehabilitation group

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.

Prehabilitation group

Standard Care (in control arm) OTHER

Participants with colorectal cancer will receive chemotherapy treatment.

Prehabilitation group; Standard Care Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of comorbidities that may significantly alter the metabolic response to exercise (e.g., diabetes mellitus).
• Current musculoskeletal injury or physical limitations that prevent completion of cardiopulmonary exercise testing (CPET).
• 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.

Sponsors & Collaborators

• Dr. Chris Gaffney: lead

Study Sites (3)

East Lancashire Teaching Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

University Hospitals Morecambe Bay Trust, Royal Lancaster Infirmary

Lancaster, Lancashire, LA1 4RP, United Kingdom

Location

Lancashire Teaching Hospitals NHS Trust

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Related Publications (1)

• Hoad KL, Ton C, Williamson D, Subar DA, Nuttall HE, Gaffney CJ. The role of prehabilitation in improving brain health and cognition after chemotherapy in patients with colorectal cancer: Study protocol of the Chemo Brain Prehab Project. PLoS One. 2026 Mar 3;21(3):e0341996. doi: 10.1371/journal.pone.0341996. eCollection 2026.

  PMID: 41774738 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Motor Activity

Interventions

Geritol; Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Christopher Gaffney, BSc (Hons.) MSc PhD FHEA

CONTACT

+44 (0) 1524 593 602; c.gaffney@lancaster.ac.uk

Katie L Hoad, BSc (Hons.) MSc PhD

CONTACT

k.hoad@lancaster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer in Integrative Physiology

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 14, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): September 16, 2027
• Study Completion (Estimated): September 16, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

GB (3)