NCT03475966

Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program

Status unknown NA Last updated 8 December 2020

What this trial tests

NA trial testing Exercise in Pancreatic Cancer in 60 participants. Status unknown.

Timeline

22 February 2017

Primary endpoint
31 December 2021

30 June 2022

Quick facts

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	22 February 2017
Primary completion	31 December 2021
Estimated completion	30 June 2022
Sites	1 location across Canada

Drugs / interventions tested

• Exercise
• Nutrition
• Relaxation techniques

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Liver Cancer — all drugs for Liver Cancer →
• Bile Duct Cancer — all drugs for Bile Duct Cancer →
• Hepatobiliary Cancer — all drugs for Hepatobiliary Cancer →

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Who can join

Adults 18 to 95, any sex, with Pancreatic Cancer or Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Major surgery is a stressful procedure; good recovery after surgery is important to patients and their doctors. Studies done at the McGill University Health Centre (MUHC) with cancer patients awaiting surgery have shown that exercise combined with simple diet recommendations (which may include a supplement) and relaxation techniques before surgery helped speed up the ability to resume walking after surgery.

These results have made the investigators aware that exercise and good nutrition are as important before surgery as they are after surgery; while it is common practice to start strengthening the body after surgery (rehabilitation), there may be some advantage to begin this process before surgery (prehabilitation).

The purpose of this study is to see if the following program, either before or after surgery, can help patients recover from liver, pancreas or bile duct surgery:

1. Exercise that may help participants move and breath better,
2. Nutrition advice and a supplement to make participants strong,
3. Relaxation and anti-anxiety tips to help cope with the stress of upcoming surgery

The investigators will see if following this program will have an effect on participants' ability to walk before and after surgery.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches.
   Cencioni C, Trestini I, Piro G, Bria E, et al · · 2022 · cited 24× · PMID 35458104 · DOI 10.3390/nu14081542
2. A review of physical activity in pancreatic ductal adenocarcinoma: Epidemiology, intervention, animal models, and clinical trials.
   Hsueh HY, Pita-Grisanti V, Gumpper-Fedus K, Lahooti A, et al · · 2022 · cited 17× · PMID 34750076 · DOI 10.1016/j.pan.2021.10.004
3. The Human Microbiomes in Pancreatic Cancer: Towards Evidence-Based Manipulation Strategies?
   Brandi G, Turroni S, McAllister F, Frega G. · · 2021 · cited 15× · PMID 34576078 · DOI 10.3390/ijms22189914
4. Exercise and Nutrition Interventions for Prehabilitation in Hepato-Pancreato-Biliary Cancers: A Narrative Review.
   Christopher CN, Kang DW, Wilson RL, Gonzalo-Encabo P, et al · · 2023 · cited 13× · PMID 38140303 · DOI 10.3390/nu15245044