NCT06542354

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

January 17, 2022

Last Update Submit

August 4, 2024

Conditions

Rectal Cancer

Keywords

prehabilitation

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

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

    at baseline, before surgery, 4 weeks and 8 weeks after surgery

Secondary Outcomes (4)

  • perioperative complication

    recorded from the day of surgery to 30 days after surgery

  • Nutrition status

    at baseline, before surgery, 4 and 8 weeks after discharge

  • Patient-reported outcome measures

    at baseline, before surgery and 30days after discharge

  • immune function markers

    at baseline, before surgery, 4 and 8 weeks after discharge

Study Arms (2)

Prehabilitation

EXPERIMENTAL

6-week trimodel prehabilitation program consists of physical exercises, nutrition supplement and mental support for patients with rectal cancer during neoadjuvant chemotherapy before surgery. All patients will receive ERAS care pattern after surgery.

Behavioral: Physical exerciseDietary Supplement: Nutrition supplementBehavioral: Mental support

Standard care

NO INTERVENTION

Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy. All patients undergoing primary leision resection will receive postoperative ERAS care.

Interventions

Physical exerciseBEHAVIORAL

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

Prehabilitation
Nutrition supplementDIETARY_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

Prehabilitation
Mental supportBEHAVIORAL

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

Prehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Xu Jianmin, MD

    Fudan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

August 7, 2024

Study Start

December 20, 2021

Primary Completion

December 30, 2023

Study Completion

March 20, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)