Modifying Your Diet to Support Muscle During Cancer Treatment.

NCT03010657 | Completed

• 1 other identifier: HREBA-CC-16-0851
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In a person with cancer, low muscle mass and strength increases the risks of suffering from severe complications of the disease, its treatment, and dying. To prevent muscle loss in cancer, stimulating muscle protein anabolism (growth) by fueling muscles with protein is crucial. Dairy products are not only a source of high-quality protein but are a preferred food choice for cancer patients as they progress through chemotherapy treatment. Although commercially available oral nutritional supplements containing essential amino acids are often promoted for protein anabolism, these products are not preferred by cancer patients. Moreover, our research group has shown that patients consuming oral nutritional supplements actually lose more weight than those who chose regular whole-food items. Evidence of the health effects of consuming dairy products is needed to influence dietary recommendations for people with cancer. The objective of our study is to perform a clinical trial to evaluate the efficacy of dairy products to maintain muscle mass and strength and improve patient outcomes in people undergoing chemotherapy treatment for cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

Skeletal muscle mass; muscle strength; dairy products; high protein diet; cancer treatment; lung cancer

Outcome Measures

Primary Outcomes (1)

• Changes in muscle mass

  CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment

  12 weeks

Secondary Outcomes (10)

• Change in muscle strength

  Baseline

• Change in muscle strength

  10 weeks

• Change in physical performance

  Baseline

• Change in physical performance

  10 weeks

• Change in quality of life

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects will add certain foods to what they normally eat.

Other: Intervention

Non-experimental intervention

NO INTERVENTION

Subjects will continue eating normally.

Interventions

Intervention OTHER

Subjects will be asked to consume certain foods during chemotherapy treatment.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of lung cancer scheduled for platinum-based chemotherapy and/or immunotherapy.
• Patients with a computed tomography (CT) image, which includes scans of the 3rd lumbar region, taken within 45 days before initiation of chemotherapy and/or immunotherapy.
• Ability to maintain oral intake.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 / Karnofsky Performance Status between 60-100.
• Ability to give written, informed consent.

You may not qualify if:

• Co-morbidities that would be expected to interfere with the primary outcome measure (e.g. neuromuscular diseases).
• Patients on long term drugs or supplements that modify muscle metabolism (e.g. corticosteroids, anti-androgens, omega-3 fatty acids).
• Life expectancy \<3 months.
• Severe food restriction(s) (e.g. food allergy, intolerance or dietary pattern) that would inhibit the study intervention food modification.
• An inability to comply with study instructions.
• Patients engaged in a total of ≥50 minutes of moderate-to-vigorous cardiovascular exercise per week and/or structured resistance exercise occurring ≥2 times per week.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Vera Mazurak, Ph.D.

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 5, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

CA (1)