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Modifying Your Diet to Support Muscle During Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03559881
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Other: High protein/high dairy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Observation
Participants with a habitual protein intake >1.2 g/kg body weight/day will be allocated to the observational arm of the study
Experimental: Intervention
Participants with a habitual protein intake <1.2 g/kg body weight/day will be allocated to the interventional arm of the study
Other: High protein/high dairy
Participants in the interventional group will receive individual dietary instruction on how to achieve at least 1.2 grams of high quality protein / kg of body weight / day, 50% from dairy products, and at least one meal per day consisting of a minimum of 30 g of high quality protein (~14 g of essential amino acids).




Primary Outcome Measures :
  1. Changes in muscle mass [ Time Frame: 12 weeks ]
    CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment


Secondary Outcome Measures :
  1. Physical function [ Time Frame: 12 weeks ]
    The short physical performance battery test

  2. Muscle strength [ Time Frame: 12 weeks ]
    hand grip strength test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559881


Contacts
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Contact: Vera Mazurak, PhD 780-492-8048 vmazurak@ualberta.ca
Contact: Sara Nejatinamini, Ms 780-318-1387 eating.strategies@ualberta.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Sara Nejatinamini, Ms    780-318-1387    eating.strategies@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Vera Mazurak, PhD University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03559881    
Other Study ID Numbers: HREBA CC-16-0851
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Skeletal muscle mass
muscle strength
dairy products
high protein diet
cancer treatment
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases