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Prehabilitation in Geriatric Patients With Colorectal Neoplasia (PIGEON)

I

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status

Enrolling

Conditions

Colo-rectal Cancer

Treatments

Other: Prehabilitation course

Study type

Interventional

Funder types

Other

Identifiers

NCT05851235
IRST153.08

Details and patient eligibility

About

This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.

Patients will follow an intensive prehabilitation course before surgery:

  • Colon cancer patients will do 4 weeks of prehabilitation before surgery.
  • Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.

The prehabilitation course is structured around the following aspects:

  • Frailty assessment and identification of optimisation fields
  • Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
  • Assessment by an integrative medicine specialist
  • Nutritional pre-qualification
  • Cardiovascular, respiratory, motor prehabilitation
  • Emotional and psychological prehabilitation

Enrollment

25 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  2. Male/female participants who are at least 70 years of age on the day of signing informed consent.
  3. Patients with confirmed diagnosis of colorectal cancer awaiting major surgery.

Exclusion criteria

  1. Clinical need for emergency intervention.
  2. Severe cognitive impairment (MMSE<20*)
  3. Severe dependency (ADL<3)
  4. Stage IV colorectal neoplasia

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Colorectal cancer patients
Experimental group
Description:
Patients with colon or rectal cancer awaiting surgery
Treatment:
Other: Prehabilitation course

Trial contacts and locations

1

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Central trial contact

Centro di Coordinamento; Isacco Montroni, MD

Data sourced from clinicaltrials.gov

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