Eating Strategies for Chemotherapy Treatment

• Sponsor: University of Alberta (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03010657
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 66.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study evaluates an eating strategy in adults undergoing chemotherapy for non-small cell lung cancer. Subjects will be allocated to a randomized or observational arm based on baseline measurements. In the randomized arm, half of participants will add certain foods to what they normally eat, while the other half will continue to eat their habitual diet. Subjects in the observational arm will continue to eat their habitual diet.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents	Other: Experimental intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Eating Strategies for Chemotherapy Treatment
• Actual Study Start Date: Jun 27, 2017
• Actual Primary Completion Date: May 31, 2020
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental intervention Subjects will add certain foods to what they normally eat.	Other: Experimental intervention; Subjects will be asked to consume certain foods during chemotherapy treatment.
No Intervention: Non-experimental intervention Subjects will continue eating normally.
No Intervention: Observational Subjects will continue eating normally.

Outcome Measures

Primary Outcome Measures

1. change in computed tomography-derived muscle mass [Baseline and 10 weeks]

   CT scan from the third vertebrae region

Secondary Outcome Measures

1. change in strength [Baseline and 10 weeks]

   hand grip

2. change in physical performance [Baseline and 10 weeks]

   short physical performance battery protocol

3. tumor response to therapy [Baseline and 10 weeks]

   change in computed tomography-derived tumor size

4. treatment-induced toxicity [6 weeks]

   National Cancer Institute Common Toxicity Criteria for toxicity grading

5. change in quality of life [Baseline and 10 weeks]

   European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (30 and LC13)

6. change in nutritional status [Baseline and 10 weeks]

   Patient Generated Subjective Global Assessment

7. change in inflammatory status [Baseline and 10 weeks]

   C-reactive protein/albumin ratio

8. change in vitamin D status [Baseline and 10 weeks]

   plasma 25-hydroxyvitamin D total, D2, and D3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with a newly confirmed diagnosis of non-small cell lung cancer scheduled for first line chemotherapy

• Patients with a computed tomography (CT) image, which includes scans of the 3rd lumbar region, taken within 45 days before initiation of chemotherapy

• 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

• Patients on long term drugs or supplements that modify muscle metabolism

• Life expectancy <3 months

• Severe food restriction(s) 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cross Cancer Institute	Edmonton	Alberta	Canada

Sponsors and Collaborators

• University of Alberta

Investigators

• Principal Investigator: Vera Mazurak, Ph.D., University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT03010657
• Other Study ID Numbers: HREBA-CC-16-0851
• First Posted: Jan 5, 2017
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 24, 2022