Non-Small Cell Lung CancerNCT03010657
Modifying Your Diet to Support Muscle During Cancer Treatment.
A study testing Intervention in people with Non-Small Cell Lung Cancer, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Intervention
- Keywords
- Skeletal muscle mass, muscle strength, dairy products, high protein diet, cancer treatment, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Subjects will be asked to consume certain foods during chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects will add certain foods to what they normally eat. Receives: Other: Intervention |
| Non-experimental intervention | No intervention | Subjects will continue eating normally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle mass
CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment
Measured: 12 weeks
Secondary outcomes (10)
Change in muscle strength
Hand grip
Measured: Baseline
Change in muscle strength
Hand grip
Measured: 10 weeks
Change in physical performance
Short physical performance battery protocol
Measured: Baseline
Change in physical performance
Short physical performance battery protocol
Measured: 10 weeks
Change in quality of life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Measured: Baseline
Change in quality of life
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)
Measured: 10 weeks
Change in nutritional status
Patient Generated Subjective Global Assessment
Measured: Baseline
Change in nutritional status
Patient Generated Subjective Global Assessment
Measured: 10 weeks
Change in inflammatory status
C-reactive protein/albumin ratio
Measured: Baseline
Change in inflammatory status
C-reactive protein/albumin ratio
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Mazurak, Ph.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010657
- Sponsor's protocol ID
- HREBA-CC-16-0851
- Status last verified
- Sep 2023
- First submitted
- 20 Dec 2016
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Products to Maintain Muscle Mass in People Undergoing Treatment for Lung Cancer
- ClinicalTrials.gov ID
- NCT03010657
- Acronym / sponsor ID
- HREBA-CC-16-0851
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Skeletal muscle mass, muscle strength, dairy products, high protein diet, cancer treatment, lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionSubjects will add certain foods to what they normally eat. |
| Non-experimental intervention | No intervention | –Subjects will continue eating normally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionSubjects will be asked to consume certain foods during chemotherapy treatment. | Other | Intervention |
Primary outcome
Changes in muscle mass
Time frame: 12 weeks
CT-derived changes in muscle mass occurring during the course of chemotherapy and/or immunotherapy treatment
10 secondary outcomes
Change in muscle strength
Time frame: Baseline
Change in muscle strength
Time frame: 10 weeks
Change in physical performance
Time frame: Baseline
Change in physical performance
Time frame: 10 weeks
Change in quality of life
Time frame: Baseline
Change in quality of life
Time frame: 10 weeks
Change in nutritional status
Time frame: Baseline
Change in nutritional status
Time frame: 10 weeks
Change in inflammatory status
Time frame: Baseline
Change in inflammatory status
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Mazurak, Ph.D. principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Non-Small Cell Lung Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle mass (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.