Improving fitness during chemotherapy for liver cancer patients
Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
NA · Institut Investigacio Sanitaria Pere Virgili · NCT04520737
This study is testing a 16-week program that combines exercise, nutrition, and support to see if it helps liver cancer patients feel fitter during chemotherapy and before surgery compared to those who only get support right before surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tarragona) |
| Trial ID | NCT04520737 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a 16-week multimodal prehabilitation program (MPP) for patients with colorectal liver metastases undergoing chemotherapy. The program includes intensive exercise training, nutritional support, smoking cessation, psychological assistance, and comprehensive geriatric assessment. The aim is to enhance physical fitness during chemotherapy and the recovery period before liver surgery, comparing outcomes with patients who only receive prehabilitation in the four weeks prior to surgery. Improvements will be measured using the six-minute walk test and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with colorectal liver metastases who can provide informed consent.
Not a fit: Patients with severe health conditions, mental disabilities, or those unable to participate in physical exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance physical fitness and overall recovery for patients undergoing treatment for colorectal liver metastases.
How similar studies have performed: While multimodal prehabilitation has shown promise in other contexts, this specific approach during chemotherapy for colorectal liver metastases is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Written informed consent obtained from subject to participate in the study. Exclusion Criteria: * Age \<18 years * ASA health class status IV-V * Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program * Medical contraindication to perform exercise * Inability to obtain informed consent
Where this trial is running
Tarragona
- Hospital Universitari de Tarragona Joan XXIII — Tarragona, Spain (RECRUITING)
Study contacts
- Principal investigator: Laia Estalella, PhD — Hospital Universitari de Tarragona Joan XXIII
- Study coordinator: Laia Estalella, PhD
- Email: laiaestalella2@gmail.com
- Phone: +34 628164461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prehabilitation, Neoadjuvant Therapy, Liver Metastases