Modifying Your Diet to Support Muscle During Cancer 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: NCT03559881|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : April 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Other: High protein/high dairy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|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|
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
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).
- Changes in muscle mass [ Time Frame: 12 weeks ]CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment
- Physical function [ Time Frame: 12 weeks ]The short physical performance battery test
- Muscle strength [ Time Frame: 12 weeks ]hand grip strength test
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
|Contact: Vera Mazurak, PhDfirstname.lastname@example.org|
|Contact: Sara Nejatinamini, Msemail@example.com|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Sara Nejatinamini, Ms 780-318-1387 firstname.lastname@example.org|
|Principal Investigator:||Vera Mazurak, PhD||University of Alberta|