Clinical trial NCT03010657: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Skeletal muscle mass
muscle strength
dairy products
high protein diet
cancer treatment
lung cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Changes in muscle mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in muscle strength
timeFrame: Baseline
measure: Change in muscle strength
timeFrame: 10 weeks
measure: Change in physical performance
timeFrame: Baseline
measure: Change in physical performance
timeFrame: 10 weeks
measure: Change in quality of life
timeFrame: Baseline
measure: Change in quality of life
timeFrame: 10 weeks
measure: Change in nutritional status
timeFrame: Baseline
measure: Change in nutritional status
timeFrame: 10 weeks
measure: Change in inflammatory status
timeFrame: Baseline
measure: Change in inflammatory status
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Vera Mazurak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: