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Eating Strategies for Chemotherapy Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03010657
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
This study evaluates an eating strategy in adults undergoing chemotherapy for non-small cell lung cancer. Subjects will be allocated to a randomized or observational arm based on baseline measurements. In the randomized arm, half of participants will add certain foods to what they normally eat, while the other half will continue to eat their habitual diet. Subjects in the observational arm will continue to eat their habitual diet.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Antineoplastic Agents Other: Experimental intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eating Strategies for Chemotherapy Treatment
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Experimental intervention
Subjects will add certain foods to what they normally eat.
Other: Experimental intervention
Subjects will be asked to consume certain foods during chemotherapy treatment.

No Intervention: Non-experimental intervention
Subjects will continue eating normally.
No Intervention: Observational
Subjects will continue eating normally.



Primary Outcome Measures :
  1. change in computed tomography-derived muscle mass [ Time Frame: Baseline and 10 weeks ]
    CT scan from the third vertebrae region


Secondary Outcome Measures :
  1. change in strength [ Time Frame: Baseline and 10 weeks ]
    hand grip

  2. change in physical performance [ Time Frame: Baseline and 10 weeks ]
    short physical performance battery protocol

  3. tumor response to therapy [ Time Frame: Baseline and 10 weeks ]
    change in computed tomography-derived tumor size

  4. treatment-induced toxicity [ Time Frame: 6 weeks ]
    National Cancer Institute Common Toxicity Criteria for toxicity grading

  5. change in quality of life [ Time Frame: Baseline and 10 weeks ]
    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)

  6. change in nutritional status [ Time Frame: Baseline and 10 weeks ]
    Patient Generated Subjective Global Assessment

  7. change in inflammatory status [ Time Frame: Baseline and 10 weeks ]
    C-reactive protein/albumin ratio

  8. change in vitamin D status [ Time Frame: Baseline and 10 weeks ]
    plasma 25-hydroxyvitamin D total, D2, and D3



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03010657


Contacts
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Contact: Sara Nejatinamini 780-318-1387 eating.strategies@ualberta.ca
Contact: Vera Mazurak, Ph.D. eating.strategies@ualberta.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact: Sara Nejatinamini       eating.strategies@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Vera Mazurak, Ph.D. University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03010657    
Other Study ID Numbers: HREBA-CC-16-0851
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases