Radiotherapy Clinical Trial
Official title:
Feasibility and Preliminary Efficacy of Aerobic Exercise in Head and Neck Cancer Patients Undergoing Radiation Therapy
NCT number | NCT04679233 |
Other study ID # | 201579 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2021 |
Est. completion date | September 2021 |
Verified date | February 2022 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treated head and neck cancer patients are subject to tissue swelling and scarring, known as lymphedema and fibrosis (LEF). LEF in the head and neck cancer patient occurs in up to 90% of treated patients and is associated with inflammation cells. Aerobic exercise is known to mediate these same inflammatory cells in an anti-inflammatory manner due to chronic adaptation of the cells. The investigators are therefore proposing a prescription exercise study for head and neck cancer patients. This study's primary aim is feasibility and safety of the aerobic exercise prescription. Feasibility of gathering study participant inflammation markers, visible LEF, and patient LEF symptoms will be a secondary aim of the study. Patient will be asked to journal their experience for a qualitative analysis. The prescription aerobic exercise is that of high intensity interval exercise, since this form of exercise can achieve similar or better results to moderate exercise with less time and patient burden. Each exercise session will take place on a cycle ergometer, will be 5 minutes warm up, 5 minutes cool down, and 20 minutes of exercise (1 minute intervals alternated by 1 minute rests x 10 each).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 18 years of age - Histologic proof of primary diagnosis of head and neck cancer - Follow routinely with primary care doctor/general practitioner as evidenced by proof of appointment within the last 24 months) - Ability to understand English in order to understand instructions and complete questionnaires - Willing to participate in the supervised exercise intervention - In the planning stages of/or actively receiving IMRT - Must sign study-specific informed consent - Medical clearance by attending physician Exclusion Criteria: - Evidence of distant metastasis prior to enrollment - Simultaneous primaries or unknown primary - Medical conditions that would prohibit the safe implementation of a an aerobic exercise practice per ACSM guidelines: cardiovascular disease, pulmonary disease, metabolic disease, or renal disease or signs/symptoms suggestive of cardiovascular disease at rest or during activity which include pain, discomfort in the chest, neck (other than caused by malignancy), jaw, arms, or other areas that may result from ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication; known heart murmur; or unusual fatigue or shortness of breath with usual activities - An answer of "no" on any of the Physical Activity Readiness Questionnaire (PAR-Q+) screening questions - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | Johns Hopkins University |
United States,
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* Note: There are 59 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative Feasibility Log of Recruitment of Participants | To assess the feasibility of recruitment of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include qualitative information regarding noted barriers to recruitment and reasons for patients not participating | 6 months | |
Primary | Quantified and Qualitative Log of Feasibility of Implementation | To investigate the feasibility of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include reasons that participants may have missed any of their assigned exercise sessions, as well as how many times they missed it. | 6 months | |
Primary | Quantified and Qualitative Retention Log of Participants | To assess retention of a prescribed HIIE aerobic exercise modality for HNC patient. This will be measured by a Researchers Log which will include information such as number of participants enrolled, number of participants who dropped out, and reason for drop-out if available | 6 months | |
Primary | Safety of the intervention as noted by parameters for serum bloodwork | To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log to ensure predetermined labs and electrolytes (platelets, magnesium, phosphorus, potassium) are within study parameter limits each week. | 6 months | |
Primary | Safety of the intervention as noted by parameters for vitals signs prior to participation | To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include ensuring vitals signs (heart rate in beats per minute, blood pressure in mmHg, oxygen in saturation, respiration rate in rate per minutes, and temperature in celsius) are within study parameter limits | 6 months | |
Primary | Safety of the intervention as noted by a timely log of adverse events, | To determine the safety of a prescribed HIIE aerobic exercise modality for HNC patients. This will be measured by a Researchers Log which will include information such as measured by the CTCAE adverse events reported in accordance with and to the IRB | 6 months | |
Secondary | Feasibility of Collecting Bloodwork - Biomarker MMP-9 | To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: MMP-9. This will be measured as a blood draw, measured as ng/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time. | 6 months | |
Secondary | Feasibility of Collecting Bloodwork at two time points - Biomarker IL-6 | To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: IL-6. This will be measured as a blood draw, measured as pg/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time. | 6 months | |
Secondary | Feasibility of Collecting Bloodwork at two time points - Biomarker IL-1ß | To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: IL-1ß. This will be measured as a blood draw, measured as pg/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time. | 6 months | |
Secondary | Feasibility of Collecting Bloodwork at two time points - Biomarker TNF-a | To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: TNF-a. This will be measured as a blood draw, measured as pg/ml. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time. | 6 months | |
Secondary | Feasibility of Collecting Bloodwork at two time points - TGF-ß1 | To assess the feasibility of collecting and using biomarkers as an outcome measure for research on the efficacy of a supervised prescribed HIIE modality for HNC patients. Collection of the following biomarkers is proposed: TGF-ß1. This will be measured as a blood draw, measured as ng/mL. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of blood draws collected at prescribed time. | 6 months | |
Secondary | Feasibility of Collecting Patient Reported Outcome at two time points | To establish the feasibility of collecting the following outcome during the supervised prescribed HIIE regiment: LEF-related patient reported symptoms. The measurement tool to be used will be a validated a reliable patient reported outcome tool called the Lymphedema Symptom Inventory Distress Screening (LSIDS). Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of LSIDS questionnaires completed in full. | 6 months | |
Secondary | Feasibility of Clinician Outcome at two time points | To establish the feasibility of collecting the following outcome during the supervised prescribed HIIE regiment: External Swelling LEF. The measurement tool to be used will be a standardized, validated, and reliable digital photography technique. Feasibility will be dichotomized and assessed as "yes" or "no" collected at both time points. Feasibility will be defined as 80% of digital photographs were able to be collected at prescribed time. Those with < 80% completed will be categorized as "no" | 6 months | |
Secondary | Qualitative data on Patient Experience | To gather preliminary feedback on the impact of a supervised prescribed HIIE regimen on patient perceived experience of the weekly exercise program as they undergo treatment via the measurement instrument of a personal and de-identified patient journal with self guided questions for patients to respond to open-endedly. This is to be analyzed qualitatively via qualitative content analysis | 6 months |
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Phase 2 | |
Recruiting |
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Recruiting |
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Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
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Phase 3 | |
Recruiting |
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FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy
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Active, not recruiting |
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Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
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Active, not recruiting |
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Radiation Pneumonitis After SBRT for NSCLC
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Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy
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Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device
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Recruiting |
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Quantitative MR Imaging in Locally Advanced Cervical Cancer
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