Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cancer and its treatments often result in severe toxicities and side effects that, over the course of treatment, results in weight loss and depletion of key nutrients. Loss of muscle mass and strength during cancer treatment is a critical problem because it negatively affects patient response and tolerance to therapy and post-treatment recovery. To restore the nutritional status, it is imperative to stimulate muscle protein anabolism. Eggs are high quality protein source, popular and well tolerated by cancer patients. Therefore, the objective of this study is to determine whether a nutritional intervention of ≥2 eggs can aid in restoring nutritional status and improving immune function and quality of life of cancer patients' post-treatment. It is an 8- week randomised clinical trial with parallel arm assignment. Half of the participants will receive the nutritional intervention (Early Intervention) and the other half will be on standard of care or usual diet for first 4 weeks. Starting from week 5, all participants will receive the nutrition intervention till week 8 (Delayed Intervention). Dietary intake (foods and nutrients), cumulative protein intake (g protein/kg body weight), immunological measures, physical performance and quality of life has been planned to be assessed over time and between groups to evaluate the feasibility of an egg intervention in meeting recommended protein intakes for patients with cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

• ≥18 years of age

• Histopathologically confirmed cancer with receipt of a platinum chemotherapy during treatment; active treatment has concluded.

• Capable of volitional oral semi-solid intake at baseline; able to maintain oral intake over the trial.

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Vera Mazurak, PhD
vmazurak@ualberta.ca
780-492-8048
Backup
Wendy Wismer, PhD
wwismer@ualberta.ca
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 90
Treatments
Experimental: Early Intervention
Participants are expected to begin intervention immediately after the completion of treatment for a period of 8 weeks.
Other: Delayed Intervention
Participants are expected to begin intervention 4 weeks after the completion of the treatment, for a period of 4 weeks (weeks 5-8).
Related Therapeutic Areas
Sponsors
Collaborators: Egg Farmers of Canada
Leads: University of Alberta

This content was sourced from clinicaltrials.gov