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Completed

NCT Number: NCT06542354

Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer

The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

This study is a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 80 years; (2) Histologically confirmed rectal adenocarcinoma;(3) Performance status (ECOG) 0-2; (4) Undergoing/scheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks. (5) Fried frailty score ≥2. Patients operated as emergency, pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded.

All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care. All patients were treated with an ERAS protocol. The primary end-point is postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated. The secondary end-points were functional walking capacity, hospital length of stay, nutrition status, patient-reported health related quality of life and immune function markers. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with rectal cancer undergoing/scheduled for neoadjuvant chemoradiotherapy
  • Fried Frailty score≥2 (intermediately frail or frail)
  • Written consent informed

Exclusion criteria

  • Co-morbiditie contraindicating physical exercise or causing disturbances of conciousness (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
  • Emergent surgery
  • ASA grade IV-V
  • Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  • Known drug abuse/ alcohol abuse

Treatment and study plan

Physical exercise

Behavioral

Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.

Nutrition supplement

Dietary Supplement

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Oral nutrition supplement (ENSURE) is provided daily seperated in 2 doses

Mental support

Behavioral

Relaxation exercise and psychological counselling delivered by weekly telephone follow-up

Primary outcomes

  1. Functional outcome

    Time frame: at baseline, before surgery, 4 weeks and 8 weeks after surgery

    Walking capacity measured by 6-minute walking distance (6MWD)

Secondary outcomes

  1. perioperative complication

    Time frame: recorded from the day of surgery to 30 days after surgery

    measured by comprehensive complication index (CCI)

  2. Nutrition status

    Time frame: at baseline, before surgery, 4 and 8 weeks after discharge

    measured by BMI and SMI

  3. Patient-reported outcome measures

    Time frame: at baseline, before surgery and 30days after discharge

    using SF-36

  4. immune function markers

    Time frame: at baseline, before surgery, 4 and 8 weeks after discharge

    specific immnue cells like CD4/CD8, cytokines, peripheral blood test.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Effect of Prehabilitation on Rectal Cancer Surgery Following Neoadjuvant Chemoradiotherapy: A Randomized Prospective Cohort Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

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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