To hear about similar clinical trials, please enter your email below
Trial Title:
Prehabilitation in Geriatric Patients With Colorectal Neoplasia
NCT ID:
NCT05851235
Condition:
Colo-rectal Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Prehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Prehabilitation course
Description:
During prehabilitation course, patients will follow a nutritional programme, a
cardiovascular and motor programme and a psychological programme.
Arm group label:
Colorectal cancer patients
Summary:
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AUSL della Romagna
Address:
City:
Ravenna
Zip:
48100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Isacco Montroni, MD
Email:
isacco.montroni@auslromagna.it
Start date:
March 22, 2023
Completion date:
March 2024
Lead sponsor:
Agency:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Agency class:
Other
Collaborator:
Agency:
Istituto Oncologico Romagnolo (IOR)
Agency class:
Other
Source:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851235
