Modifying Your Diet to Support Muscle During Cancer Treatment.

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03010657
• Other study ID #: HREBA-CC-16-0851
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: September 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03559881

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Other:
• Intervention
Subjects will be asked to consume certain foods during chemotherapy treatment.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in muscle mass	CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment	12 weeks
Secondary	Change in muscle strength	Hand grip	Baseline
Secondary	Change in muscle strength	Hand grip	10 weeks
Secondary	Change in physical performance	Short physical performance battery protocol	Baseline
Secondary	Change in physical performance	Short physical performance battery protocol	10 weeks
Secondary	Change in quality of life	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)	Baseline
Secondary	Change in quality of life	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)	10 weeks
Secondary	Change in nutritional status	Patient Generated Subjective Global Assessment	Baseline
Secondary	Change in nutritional status	Patient Generated Subjective Global Assessment	10 weeks
Secondary	Change in inflammatory status	C-reactive protein/albumin ratio	Baseline
Secondary	Change in inflammatory status	C-reactive protein/albumin ratio	10 weeks