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Modifying Your Diet to Support Muscle During Cancer Treatment.

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-Small Cell Lung Cancer focused on measuring Skeletal muscle mass, muscle strength, dairy products, high protein diet, cancer treatment, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a newly confirmed diagnosis of non-small cell lung cancer scheduled for first line chemotherapy
  • Patients with a computed tomography (CT) image, which includes scans of the 3rd lumbar region, taken within 45 days before initiation of chemotherapy
  • 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

Exclusion Criteria:

  • Co-morbidities that would be expected to interfere with the primary outcome measure
  • Patients on long term drugs or supplements that modify muscle metabolism
  • Life expectancy <3 months
  • Severe food restriction(s) 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

Sites / Locations

  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Non-experimental intervention

Arm Description

Subjects will add certain foods to what they normally eat.

Subjects will continue eating normally.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in muscle strength
Hand grip
Change in muscle strength
Hand grip
Change in physical performance
Short physical performance battery protocol
Change in physical performance
Short physical performance battery protocol
Change in quality of life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Change in quality of life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Change in nutritional status
Patient Generated Subjective Global Assessment
Change in nutritional status
Patient Generated Subjective Global Assessment
Change in inflammatory status
C-reactive protein/albumin ratio
Change in inflammatory status
C-reactive protein/albumin ratio

Full Information

First Posted
December 20, 2016
Last Updated
September 21, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03010657
Brief Title
Modifying Your Diet to Support Muscle During Cancer Treatment.
Official Title
Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Muscle wasting is prevalent among cancer patients and cancer treatment can lead to further muscle depletion which is associated with poor outcomes. Dairy products contain complete proteins of high quality and our previous study has shown a preference for dairy products in cancer patients during cancer treatment. This study aims to demonstrate a proof of principle that consumption of a diet high in protein and rich in dairy products will support the maintenance of muscle mass and strength, therefore improving outcomes in cancer patients undergoing treatment. Methods: The primary outcome is change in muscle mass during cisplatin and/or immunotherapy treatment. Skeletal muscle index was measured by computed tomography (CT). To assess the physical function and muscle strength of patients, short physical performance battery and hand-held dynamometry tests were performed. Patients whose habitual protein intakes were low, received individual dietary instruction from a registered dietician on how to achieve at least one meal per day consisting of a minimum of 30 g of protein derived from at least 50% dairy products as well as 50% of total protein intake from dairy. Patients in a conventional control group continued their habitual dietary intake along with the standard of care. Subjects in the intervention group began consuming their diets immediately after all baseline measurements were collected and continued through treatment, lasting until their follow-up CT scan. Results: This trial is in progress. It is expected that high protein diet rich in dairy products can maintain patient muscle mass and strength during chemotherapy compared to a low protein diet. Conclusions: This study will represent a food based nutrition intervention that addresses limiting nutrients to improve outcomes for cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Skeletal muscle mass, muscle strength, dairy products, high protein diet, cancer treatment, lung cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects will add certain foods to what they normally eat.
Arm Title
Non-experimental intervention
Arm Type
No Intervention
Arm Description
Subjects will continue eating normally.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Subjects will be asked to consume certain foods during chemotherapy treatment.
Primary Outcome Measure Information:
Title
Changes in muscle mass
Description
CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
Hand grip
Time Frame
Baseline
Title
Change in muscle strength
Description
Hand grip
Time Frame
10 weeks
Title
Change in physical performance
Description
Short physical performance battery protocol
Time Frame
Baseline
Title
Change in physical performance
Description
Short physical performance battery protocol
Time Frame
10 weeks
Title
Change in quality of life
Description
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Time Frame
Baseline
Title
Change in quality of life
Description
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Time Frame
10 weeks
Title
Change in nutritional status
Description
Patient Generated Subjective Global Assessment
Time Frame
Baseline
Title
Change in nutritional status
Description
Patient Generated Subjective Global Assessment
Time Frame
10 weeks
Title
Change in inflammatory status
Description
C-reactive protein/albumin ratio
Time Frame
Baseline
Title
Change in inflammatory status
Description
C-reactive protein/albumin ratio
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Mazurak, Ph.D.
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

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Modifying Your Diet to Support Muscle During Cancer Treatment.

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