NCT05379205

Brief Summary

ONCOFIT is a randomized clinical trial with a two-arm parallel design aimed at determining the influence of a multidisciplinary prehabilitation + postoperative program on post-surgery complications in patients undergoing resection of colon cancer. This intervention will include supervised physical exercise, dietary behavior change, and psychological support comparing its influence to the standard care.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

April 23, 2022

Last Update Submit

July 17, 2025

Conditions

Colon CancerPostoperative Complications

Keywords

Post-surgery complicationsMultidisciplinary interventionExerciseDietary behaviourPsychological support

Outcome Measures

Primary Outcomes (1)

  • Post-surgery complications

    Post-surgery complications determined by the Comprehensive Complication Index (CCI). Minimum value: 0 // Maximum value: 100. Higher scores mean a worse outcome.

    30-days and 3-months post-surgery

Secondary Outcomes (45)

  • Post-surgery complications

    1-year post-surgery (i.e., week 57)

  • Additional surgery-derived events

    1-year post-surgery (i.e., week 57).

  • Post-surgery complications

    30-days, 3-months and 1-year post-surgery

  • Additional surgery-derived events

    30-days, 3-months and 1-year post-surgery

  • Additional surgery-derived events

    30-days, 3-months and 1-year post-surgery

  • +40 more secondary outcomes

Study Arms (2)

Usual Care/Control Group

ACTIVE COMPARATOR

Usual care group will follow the usual institutional pre-surgery care..

Other: Usual Care

Prehabilitation + Postoperative Programs (PPP) Group

EXPERIMENTAL

PPP group will include 3 complementary modules: (i) supervised physical exercise, (ii) dietary behavior change, and (iii) psychological support.

Behavioral: Prehabilitation program (4 week before the surgery)Behavioral: Postoperative program (12 week after the surgery)

Interventions

Prehabilitation program (4 week before the surgery)BEHAVIORAL

This intervention will include 3 complementary modules: (i) supervised physical exercise: aerobic and strength High Intensity Interval Training (HIIT), 3 times per week (ii) dietary behavior change: nutritional talk + an informative brochure + a video summary, a session per week and (iii) psychological support: psychoeducation, written and verbal emotional expression, promotion of coping strategies, progressive muscle relaxation training, problem-solving and social skills, and self-efficacy enhancing, among others. This psychological component will also include counseling regarding smoking and alcohol cessation and sleep hygiene.

Prehabilitation + Postoperative Programs (PPP) Group
Postoperative program (12 week after the surgery)BEHAVIORAL

This intervention will include 3 complementary modules: (i) supervised physical exercise: aerobic and strength High Intensity Interval Training (HIIT), 3 times per week (ii) dietary behavior change: nutritional talk + an informative brochure + a video summary, a session per week and (iii) psychological support: psychoeducation, written and verbal emotional expression, promotion of coping strategies, progressive muscle relaxation training, problem-solving and social skills, and self-efficacy enhancing, among others. This psychological component will also include counseling regarding smoking and alcohol cessation and sleep hygiene. NOTE: Both preoperative and postoperative programs will be administer to the participants assigned to the intervention group.

Prehabilitation + Postoperative Programs (PPP) Group
Usual CareOTHER

Usual care group will follow the usual institutional pre-surgery care: (i) medication management, (ii) assessment of the surgery-derived risks, (iii) smoking cessation and peri-operative blood management. A trained nutritionist will evaluate the nutritional status of all patients at the baseline providing oral protein/vitamin supplementation, when necessary. Patients allocated to the control group will receive basic expert' advice on lifestyle changes.

Usual Care/Control Group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 40 years
  • Diagnostic of nonmetastatic colon cancer (i.e., including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
  • Not participating in a nutritional/ dietary intervention
  • Being physical inactive (i.e., not to be participating in any physical exercise program in the last 3 months, or performing less than 600 metabolic equivalents (METS)/week of moderate-vigorous physical activity).
  • To be capable and willing to provide informed consent
  • Not to suffer from any specific condition that may impede testing of the study hypothesis or make it unsafe to engage in the multidisciplinary intervention (i.e., determined by the research staff).

You may not qualify if:

  • Medical contraindication for being engaged in an exercise or dietary program.
  • Additional surgery planned within the 3-month intervention
  • History of another primary invasive cancer
  • Planning to receive adjuvant chemotherapy
  • To be pregnant
  • To present any of the following cardiac conditions: (i) myocardial infarction or coronary revascularization procedure within prior 3 months, (ii) uncontrolled hypertension (i.e., systolic ≥180 mmHg or diastolic ≥100 mmHg), (iii) uncontrolled arrhythmias (iv) valvular disease clinically significant, (v) decompensated heart failure or (vi) to suffer from known aortic aneurysm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Physiology, Faculty of Medicine, University of Granada

Granada, Andalusia, 18007, Spain

Location

Related Publications (10)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND

  • Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

    PMID: 33239350BACKGROUND

  • Mentella MC, Scaldaferri F, Ricci C, Gasbarrini A, Miggiano GAD. Cancer and Mediterranean Diet: A Review. Nutrients. 2019 Sep 2;11(9):2059. doi: 10.3390/nu11092059.

    PMID: 31480794BACKGROUND

  • Cheville AL, Mustian K, Winters-Stone K, Zucker DS, Gamble GL, Alfano CM. Cancer Rehabilitation: An Overview of Current Need, Delivery Models, and Levels of Care. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):1-17. doi: 10.1016/j.pmr.2016.08.001.

    PMID: 27912990BACKGROUND

  • Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.

    PMID: 31968063BACKGROUND

  • Fulop A, Lakatos L, Susztak N, Szijarto A, Banky B. The effect of trimodal prehabilitation on the physical and psychological health of patients undergoing colorectal surgery: a randomised clinical trial. Anaesthesia. 2021 Jan;76(1):82-90. doi: 10.1111/anae.15215. Epub 2020 Aug 6.

    PMID: 32761611BACKGROUND

  • Minnella EM, Bousquet-Dion G, Awasthi R, Scheede-Bergdahl C, Carli F. Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. Acta Oncol. 2017 Feb;56(2):295-300. doi: 10.1080/0284186X.2016.1268268. Epub 2017 Jan 12.

    PMID: 28079430BACKGROUND

  • Frawley HC, Lin KY, Granger CL, Higgins R, Butler M, Denehy L. An allied health rehabilitation program for patients following surgery for abdomino-pelvic cancer: a feasibility and pilot clinical study. Support Care Cancer. 2020 Mar;28(3):1335-1350. doi: 10.1007/s00520-019-04931-w. Epub 2019 Jun 27.

    PMID: 31250182BACKGROUND

  • Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

    PMID: 23728278BACKGROUND

  • Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.

    PMID: 25379846BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsPostoperative ComplicationsMotor Activity

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Francisco J Amaro-Gahete, PhD, MD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 18, 2022

Study Start

November 1, 2022

Primary Completion

July 17, 2025

Study Completion

May 1, 2026

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)