Non-small Cell Lung CancerNCT07234799
Feasibility Testing of a Dyadic Exercise Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers
A study testing Exercise in people with Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to examine the feasibility and acceptability of an exercise intervention for patients undergoing thoracic radiation and their family caregivers. 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?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to 4 May 2028
- 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
- Be diagnosed with a non-small cell lung cancer or esophageal cancer and going to receive at least 24 fractions thoracic RT
- Have an ECOG performance status of ≤2
- Have a family caregiver (e.g., spouse, sibling, adult child) willing and able (self-identified) to participate in the exercise program
- Both patient and caregiver must meet all the following criteria:
- Be ≥18 years old
- Be able to read and speak English
- Be able to provide informed consent
Who cannot join
- A patient who meets the following criteria will be excluded from participating in this study:
- Cognitive deficits noted in the medical records and/or cognitive deficits that would impede the completion of self-report instruments as deemed by the patient's attending radiation oncologist.
- Experiences contraindications to exercise as determined by the clinical team
- Regularly (self-defined) participates in an exercise program in the year prior to diagnosis
- A patient and caregiver who is pregnant (medical notes and/or self-identified, respectively) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this study is to examine the feasibility and acceptability of an exercise intervention for patients undergoing thoracic radiation and their family caregivers.
Read the detailed description
Primary Objectives:
- Examine the feasibility and acceptability of an exercise program
- Examine an initial sign for intervention efficacy by examining pre/post-test scores for patients' objective physical function and patient and caregiver subjective physical and mental quality of life.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Exercise
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Study participants will engage in 7-10 exercises per session targeting major muscle groups (e.g. quadriceps, hamstrings, glutes, back, chest, arms, abdominal muscles). Movements will alternate between the lower and upper body thus allowing ample time for muscle-group recovery between exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Protocol | Experimental | The protocol will be comprised of up to 15 exercise sessions over the course of participants' 5-6 weeks radiation treatment period with each session lasting up to 60 minutes. Exercise sessions are a combination of resistance, aerobic, and flexibility training using bodyweight and/or elastic bands for resistance. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Patients and caregivers will complete the Medical Outcomes. Study 36-item short-form survey (SF-36) assessing 8 distinct domains of QOL
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start18 Sep 2025
- Primary completion4 May 2028 (estimated)
- Study completion4 May 2028 (estimated)
Why it stopped: PI Request
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 M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, MA,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234799
- Sponsor's protocol ID
- 2025-0744
- Other IDs
- NCI-2025-07868
- Status last verified
- Jul 2026
- First submitted
- 22 Oct 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Dyadic Exercise Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT07234799
- Acronym / sponsor ID
- 2025-0744
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI Request
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 4 May 2028 (estimated)
- Study completion
- 4 May 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- 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.
The goal of this study is to examine the feasibility and acceptability of an exercise intervention for patients undergoing thoracic radiation and their family caregivers.
Detailed description
Primary Objectives:
- Examine the feasibility and acceptability of an exercise program
- Examine an initial sign for intervention efficacy by examining pre/post-test scores for patients' objective physical function and patient and caregiver subjective physical and mental quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Protocol | Experimental | Other: ExerciseThe protocol will be comprised of up to 15 exercise sessions over the course of participants' 5-6 weeks radiation treatment period with each session lasting up to 60 minutes. Exercise sessions are a combination of resistance, aerobic, and flexibility training using bodyweight and/or elastic bands for resistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be diagnosed with a non-small cell lung cancer or esophageal cancer and going to receive at least 24 fractions thoracic RT
- Have an ECOG performance status of ≤2
- Have a family caregiver (e.g., spouse, sibling, adult child) willing and able (self-identified) to participate in the exercise program
- Be ≥18 years old
- Be able to read and speak English
Key exclusion criteria (5 listed)
- A patient who meets the following criteria will be excluded from participating in this study:
- Cognitive deficits noted in the medical records and/or cognitive deficits that would impede the completion of self-report instruments as deemed by the patient's attending radiation oncologist.
- Experiences contraindications to exercise as determined by the clinical team
- Regularly (self-defined) participates in an exercise program in the year prior to diagnosis
- A patient and caregiver who is pregnant (medical notes and/or self-identified, respectively) will be excluded.
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 |
|---|---|---|
| ExerciseStudy participants will engage in 7-10 exercises per session targeting major muscle groups (e.g. quadriceps, hamstrings, glutes, back, chest, arms, abdominal muscles). Movements will alternate between the lower and upper body thus allowing ample time for muscle-group recovery between exercises. | Other | Exercise Protocol |
Primary outcome
Quality of Life Questionnaire
Time frame: Through study completion; an average of 1 year
Patients and caregivers will complete the Medical Outcomes. Study 36-item short-form survey (SF-36) assessing 8 distinct domains of QOL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Kathrin Milbury, MA,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 7 inclusion and 5 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: paused, as of the sponsor's last update on 3 Aug 2026. 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 United States. 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?
Results are not available in the source record.
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?
Quality of Life Questionnaire (time frame: Through study completion; an average of 1 year). 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 3 Aug 2026.