Cross Cancer Institute
Edmonton, Alberta, Canada
NCT Number: NCT03010657
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be asked to consume certain foods during chemotherapy treatment.
Time frame: 12 weeks
CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment
Time frame: Baseline
Hand grip
Time frame: 10 weeks
Hand grip
Time frame: Baseline
Short physical performance battery protocol
Time frame: 10 weeks
Short physical performance battery protocol
Time frame: Baseline
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Time frame: 10 weeks
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Time frame: Baseline
Patient Generated Subjective Global Assessment
Time frame: 10 weeks
Patient Generated Subjective Global Assessment
Time frame: Baseline
C-reactive protein/albumin ratio
Time frame: 10 weeks
C-reactive protein/albumin ratio
University of Alberta
Other
Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer
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