What is the mechanism of action of this treatment?

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy targets rapidly dividing cancer cells, disrupting their growth and replication. Radiation therapy uses high-energy rays to destroy cancer cells in specific areas. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for NHL patients as they directly target and reduce cancerous cells, improving survival rates. Additionally, incorporating physical activity and educational workshops can enhance cardiovascular health, muscle strength, cognitive function, and overall well-being, which are essential for managing side effects and improving quality of life during and after treatment.

What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as chemotherapy and radiation therapy, can lead to side effects including fatigue, peripheral neuropathy, increased risk of infections, cardiovascular issues, and pulmonary dysfunction. These treatments can also contribute to mental health challenges like depression and anxiety. Engaging in physical activity can help improve cardiovascular health, muscle strength, and cognitive function, while educational workshops can provide strategies for a healthier lifestyle, potentially reducing stress and enhancing overall well-being.

What prior FDA approvals exist?

FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL) include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. While these treatments primarily focus on eradicating cancer cells, complementary approaches such as physical activity and educational workshops are also beneficial. Physical activity has been shown to improve cardiovascular health, muscle strength, and cognitive function, which are crucial for NHL survivors. Educational workshops provide knowledge and strategies for a healthier lifestyle, potentially reducing stress and improving overall well-being. These supportive care measures are essential in enhancing the quality of life for NHL patients and survivors.

What other types of research exist?

Promising novel alternatives for Non-Hodgkin's Lymphoma patients include: 1) Mindfulness-based interventions, such as Mindfulness-Based Stress Reduction (MBSR), which can help manage stress and improve quality of life. 2) Biofeedback and neurofeedback therapies, which have shown potential in managing pain and chemotherapy-induced peripheral neuropathy. 3) Complementary therapies like yoga, Tai Chi, and Qigong, which can improve physical and psychological outcomes, including fatigue and mood. 4) Music therapy, which has been effective in reducing pain and anxiety, and improving overall well-being.

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Tailored Exercise Program for Cancer Patients (PALS Trial)

N/A

Recruiting

Led By William Hundley, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 3 months and 6 months after study intervention

Awards & highlights

PALS Trial Summary

This trial will test if physical activity/educational classes help preserve exercise, heart function, brain activities & quality of life for cancer patients.

Who is the study for?

This trial is for adults aged 18-85 with Hodgkin's or non-Hodgkin's lymphoma who can walk two city blocks and are expected to undergo certain cancer therapies. They must speak English, have a survival expectancy beyond 6 months, and an assistant for home-based activities. Exclusions include uncontrolled high blood pressure, MRI contraindications, recent heart attack, inability to exercise on treadmill/cycle, pregnancy, drug abuse history, inflammatory conditions or other safety-compromising medical issues.Check my eligibility

What is being tested?

The study compares the effects of a physical activity program using Trainerize app and educational workshops on preserving exercise capacity during cancer treatment. Participants will be randomly assigned to either attend health workshops focusing on lifestyle education or engage in moderate physical activities remotely or in person throughout their treatment.See study design

What are the potential side effects?

Potential side effects from participating may include muscle soreness from exercise; stress due to time commitment; discomfort from wearing fitness tracking devices; possible anxiety related to health monitoring through questionnaires and tests like MRI scans and blood draws.

PALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 3 months and 6 months after study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 3 months and 6 months after study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 3 months and 6 months after study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Peak VO2

Secondary outcome measures

Change in 6-Minute Walk Distance

Change in Calculated A-V Oxygen Levels

Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)

+12 more

PALS Trial Design

2Treatment groups

Experimental Treatment

Group I: Physical Activity InterventionExperimental Treatment6 Interventions

Participants will have the ability to attend one to two training sessions per week and 1-2 sessions per week at home (the 4th level of our multi-level intervention) or the location site using the Trainerize application to deliver the exercise prescription.

Group II: Healthy Living Intervention (Control Arm)Experimental Treatment5 Interventions

Participants randomized to the control arm will participate in organized health workshops. Each session will last 60 minutes and will be offered on location and virtually (e.g., Zoom) over 6 months. Participants will meet once a week for the first 4 weeks, biweekly for 3 months, and once a month for the last 2 months for a total of 12 sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI scan

2022

Completed Phase 4

~2690

Quality of Life Questionnaires

2005

Completed Phase 4

~1380

Cardiopulmonary exercise testing

2012

N/A

~1000

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy targets rapidly dividing cancer cells, disrupting their growth and replication. Radiation therapy uses high-energy rays to destroy cancer cells in specific areas. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for NHL patients as they directly target and reduce cancerous cells, improving survival rates. Additionally, incorporating physical activity and educational workshops can enhance cardiovascular health, muscle strength, cognitive function, and overall well-being, which are essential for managing side effects and improving quality of life during and after treatment.

The impact of treatment, socio-demographic and clinical characteristics on health-related quality of life among Hodgkin's and non-Hodgkin's lymphoma survivors: a systematic review.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,718 Previous Clinical Trials

40,953,244 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,250 Previous Clinical Trials

1,007,053 Total Patients Enrolled

William Hundley, MDPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center

Media Library

Tailored Physical Activity Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05595577 — N/A

Non-Hodgkin's Lymphoma Research Study Groups: Physical Activity Intervention, Healthy Living Intervention (Control Arm)

Non-Hodgkin's Lymphoma Clinical Trial 2023: Tailored Physical Activity Intervention Highlights & Side Effects. Trial Name: NCT05595577 — N/A

Tailored Physical Activity Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595577 — N/A

~50 spots leftby Sep 2025

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