Hodgkin LymphomaNCT03923504
Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
A study testing Physical Activity Intervention (PAI) in people with Hodgkin Lymphoma and Non-hodgkin Lymphoma, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hodgkin Lymphoma, Non-hodgkin Lymphoma, Lymphoma
- What is being tested?
- Physical Activity Intervention (PAI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2019to 18 Apr 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18-85 years old
- Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).
Who cannot join
- Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID19.
- Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- A recent history of alcohol or drug abuse
- Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion
- Other exclusions include those with contraindications to MRI; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
Virginia Commonwealth University Community Memorial Health Center
South Hill, Virginia, 23970
About this study
Official title: Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.
Read the detailed description
This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
- Conditions
- Hodgkin Lymphoma, Non-hodgkin Lymphoma, Lymphoma, Breast Cancer
- Being tested
- Physical Activity Intervention (PAI), Healthy Living Control
- Keywords
- Physical Activity Intervention, Healthy Living Intervention, Health-related Quality of Life
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Intervention (PAI)Other
Those who opt-in to attend in-person study visits and to undergo COVID testing will also complete an MRI exam and CPET testing. Participants unwilling to have COVID testing done will only complete an MRI exam and home-based testing. All testing will take place either within 6 weeks of initiating systemic treatments or within 8 weeks of completing radiation then at 3 \& 6 months. Patients may participate in 1-2 training sessions per week offered under the direct supervision of a master's level clinical exercise physiologist, as well as 1-2 sessions at home. PAI sessions consist of slow aerobic warm-up, followed by 20 minutes of strength training,15 minutes of progressive intensity aerobic exercise (AE), and then 10 minutes of stretching for cool-down. Participants will have the ability to participate in training sessions facilitated via online channels at home.
Healthy Living ControlOther
Patients randomized to the control arm will either attend online sessions via secure video conferencing (e.g. Zoom) or telephone or to come to a centralized meeting location (if safety allows) to participate in organized health workshops. Session attendance will be required 2 times/month (over the 6 months). Make up sessions will be offered for those participants who have to miss a group session. Each session lasts 60 minutes and matches the number of visits made by the PAI group as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention (PAI) | Active comparator | Tailored multi-level physical activity intervention (PAI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC). Receives: Other: Physical Activity Intervention (PAI) |
| Healthy Living Control Group | Active comparator | Healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC). Receives: Other: Healthy Living Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Patient Interest in Protocol
Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.
Measured: 6 Months
Assessment of Patient Compliance
Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
Measured: 6 Months
Assessment of Patient Response to Interventions
Examination of qualitative data to evaluate positive and negative influences on adherence and to refine the intervention for a future large scale utilizing recorded interviews with each of the accrued subjects.
Measured: 6 Months
Secondary outcomes (7)
Assessment of Cardiac Output
Assessment of the subject's peak exercise cardiac output at the initial visit, then at 3 and 6 months after starting Anthracycline-based Chemotherapy (Anth-bC) utilizing Magnetic Resonance Imaging (MRI) variables, and Cardiopulmonary Exercise Testing (CPET).
Measured: 6 Months
Assessment of Oxygen Output
Assessment of oxygen output will be determined by using measurements from maximal oxygen intake, and a six-minute walk test to obtain exercise capacity.
Measured: 6 Months
Assessment of Health Related Quality of Life
Health related quality of life will be measured using the Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire to assess disease-specific health related quality of life (HRQoL). The FACT-Lym scale measures HRQoL using a forty-two question assessment that measures physical well-being, social well-being, and emotional well-being. Each item on the FACT-Lym scale is scored from 0 (Not at all) to 4 (very much). All items are summed to create a total score (range 0-108) and sub-scales may be scored separately for questions related to physical well-being (range 0-28), social well-being (range 0-28), emotional well-being (range 0-24), functional well-being (range 0-28), and for lymphoma specific additional concerns (range 0-60). Negatively worded items are reverse scored prior to summing so that higher sub-scale and total scores indicate better QoL.
Measured: 6 Months
Assessment of Fatigue
Fatigue will be assessed by utilizing the Functional Assessment of Cancer Therapy-Fatigue scale (FACT-fatigue) assess fatigue. The FACT-fatigue scale assesses cancer related fatigue using a thirteen question scale. Each item on the FACT-Fatigue scale is scored from 0 (not at all) to 4 (very much). All items on the scale are summed to provide a total score for fatigue (range 0-52)
Measured: 6 Months
Assessment of General Health
The MOS 36-item Short Form Health Survey (SF-36) will also be used to to measure subject's general health. All items on the SF-36 are scored from 1 (excellent) to 5 (poor). Scores are calculated for eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.
All items are scored so that a high score defines a more favorable health state. each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.
Measured: 6 Months
Assessment for Anemia
Blood will be obtained at each study visit to assess hemoglobin and hematocrit levels.
Measured: 6 Months
Assessment of Renal Function
Blood will be obtained at each study visit to assess for renal (kidney) dysfunction
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start10 May 2019
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Lucas, Ph.D., Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923504
- Sponsor's protocol ID
- MCC-19-14621
- Status last verified
- Mar 2023
- First submitted
- 16 Apr 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
- ClinicalTrials.gov ID
- NCT03923504
- Acronym / sponsor ID
- MCC-19-14621
- Conditions
- Hodgkin Lymphoma, Non-hodgkin Lymphoma, Lymphoma, Breast Cancer
- Keywords
- Physical Activity Intervention, Healthy Living Intervention, Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 22 Apr 2019 (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.
To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.
Detailed description
This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention (PAI) | Active comparator | Other: Physical Activity Intervention (PAI)Tailored multi-level physical activity intervention (PAI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC). |
| Healthy Living Control Group | Active comparator | Other: Healthy Living ControlHealthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects age 18-85 years old
- Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).
Key exclusion criteria (5 listed)
- Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID19.
- Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
- A recent history of alcohol or drug abuse
- Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion
- Other exclusions include those with contraindications to MRI; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.
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 |
|---|---|---|
| Physical Activity Intervention (PAI)Those who opt-in to attend in-person study visits and to undergo COVID testing will also complete an MRI exam and CPET testing. Participants unwilling to have COVID testing done will only complete an MRI exam and home-based testing. All testing will take place either within 6 weeks of initiating systemic treatments or within 8 weeks of completing radiation then at 3 \& 6 months. Patients may participate in 1-2 training sessions per week offered under the direct supervision of a master's level clinical exercise physiologist, as well as 1-2 sessions at home. PAI sessions consist of slow aerobic warm-up, followed by 20 minutes of strength training,15 minutes of progressive intensity aerobic exercise (AE), and then 10 minutes of stretching for cool-down. Participants will have the ability to participate in training sessions facilitated via online channels at home. | Other | Physical Activity Intervention (PAI) |
| Healthy Living ControlPatients randomized to the control arm will either attend online sessions via secure video conferencing (e.g. Zoom) or telephone or to come to a centralized meeting location (if safety allows) to participate in organized health workshops. Session attendance will be required 2 times/month (over the 6 months). Make up sessions will be offered for those participants who have to miss a group session. Each session lasts 60 minutes and matches the number of visits made by the PAI group as much as possible. | Other | Healthy Living Control Group |
Primary outcome
Assessment of Patient Interest in Protocol
Time frame: 6 Months
Feasibility for a larger study will be determined by the number of patients that agree to participate in the trial.
Assessment of Patient Compliance
Time frame: 6 Months
Data collected will determine how many patients complete all protocol activities to determine feasibility of the interventions.
Assessment of Patient Response to Interventions
Time frame: 6 Months
Examination of qualitative data to evaluate positive and negative influences on adherence and to refine the intervention for a future large scale utilizing recorded interviews with each of the accrued subjects.
7 secondary outcomes
Assessment of Cardiac Output
Time frame: 6 Months
Assessment of Oxygen Output
Time frame: 6 Months
Assessment of Health Related Quality of Life
Time frame: 6 Months
Assessment of Fatigue
Time frame: 6 Months
Assessment of General Health
Time frame: 6 Months
Assessment for Anemia
Time frame: 6 Months
Assessment of Renal Function
Time frame: 6 Months
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 7 Mar 2023.
- NCT01719562: MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity AddendumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alexander Lucas, Ph.D. principal investigator
Massey Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Intervention (PAI) in people with Hodgkin Lymphoma and Non-hodgkin Lymphoma, run by Virginia Commonwealth University at 2 sites 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 2 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: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Assessment of Patient Interest in Protocol (time frame: 6 Months). The study lists 3 primary outcomes in all. 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 7 Mar 2023.