Nutrition and Exercise Plan for Leukemia/Lymphoma

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: Prednisone, Dexamethasone

Disqualifiers: Nutrition counseling, Psychological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a nutrition and exercise plan can prevent weight gain in children with leukemia or lymphoma who receive certain steroids, specifically prednisone and dexamethasone. The study will compare two groups: one will attend nutrition counseling sessions, while the other will participate in tasting sessions for healthy recipes and exercise sessions. Children with leukemia or lymphoma, receiving the specified steroid treatment, and being treated at MD Anderson Children's Cancer Hospital may be suitable candidates for this trial. As an Early Phase 1 trial, the study focuses on understanding how the nutrition and exercise plan affects children, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you are already receiving prednisone and/or dexamethasone as part of your treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nutrition and exercise plans are generally safe for cancer patients, including those with leukemia or lymphoma. Studies have found that dietary changes, such as reducing fat and sugar intake, can be safe and might help manage cancer symptoms. Good nutrition may also help patients cope better with treatment side effects.

For exercise, research indicates it is safe and manageable for people with blood cancers. Exercise can boost fitness levels without major risks. Most patients find these programs easy to follow and helpful.

In the early phase of this trial, the main goal is to understand safety and side effects. The nutrition and exercise plans are expected to be safe, but researchers are still collecting detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how integrating nutrition and exercise can support leukemia and lymphoma treatment. Unlike typical medication-focused approaches, this trial emphasizes lifestyle changes, such as personalized nutrition counseling and physical activity sessions. These interventions aim to improve overall health, potentially enhancing the effectiveness of traditional treatments like Dexamethasone and Prednisone. By focusing on lifestyle, this trial could pave the way for holistic therapies, offering a new dimension to cancer care.

What evidence suggests that this trial's treatments could be effective in preventing excess weight gain in pediatric patients with leukemia or lymphoma?

Research has shown that eating the right foods can help cancer patients feel better. Studies have found that good nutrition can increase energy and protein levels, which are important for those undergoing treatment. Eating well may also help slow the growth of cancer. In this trial, participants in Arm I will receive counseling focused on nutrition.

Exercise is also safe and beneficial during cancer treatments. It can improve body function and enhance quality of life for people with leukemia or lymphoma. Participants in Arm II of this trial will engage in both nutrition and physical activity interventions. These findings suggest that combining good nutrition with exercise can help manage weight and improve overall health during treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Joya Chandra

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for pediatric leukemia or lymphoma patients at MD Anderson Children's Cancer Hospital who are currently being treated with prednisone and/or dexamethasone. Participants must have a good performance status, be cleared by their oncologist, and live close enough to attend sessions. Those already getting nutrition/weight counseling or on non-treatment steroids, or with certain psychological disorders can't join.

Inclusion Criteria

Must be cleared by treating oncologist to participate in study

I am a leukemia or lymphoma patient at MD Anderson Children's Cancer Hospital.

I am currently taking prednisone or dexamethasone at MD Anderson Children's Cancer Hospital.

Exclusion Criteria

I am currently getting advice on diet or weight management.

History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)

I am a child taking steroids not related to my cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend nutrition counseling sessions or tasting and physical activity sessions

1 year

13 visits (in-person) for Arm I; 4 visits (in-person) for Arm II

Follow-up

Participants are monitored for changes in waist circumference, BMI, and other health parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Dexamethasone
• Exercise Intervention
• Informational Intervention
• Nutritional Intervention
• Prednisone

Trial Overview The study is testing whether a program of nutritional guidance and physical activity can prevent kids receiving steroid treatment for leukemia or lymphoma from gaining too much weight. It involves exercise routines, dietary advice, educational materials about health habits, and regular questionnaires.

How Is the Trial Designed?

Group I: Arm II (nutrition and PA intervention) Experimental Treatment 3 Interventions

Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.

Group II: Arm I (counseling) Active Control 3 Interventions

Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In the EURO-LB02 trial involving 319 patients with lymphoblastic lymphoma, the 5-year event-free survival rate was 82%, but the previously reported 90% rate for T-cell lymphoblastic lymphoma was not achieved, primarily due to increased toxic deaths and central nervous system relapses.

Patients receiving dexamethasone during induction experienced significantly more severe toxicities compared to those on prednisone, leading to treatment delays, although dexamethasone may be more effective in preventing central nervous system relapses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results and conclusions of the European Intergroup EURO-LB02 trial in children and adolescents with lymphoblastic lymphoma. Landmann, E., Burkhardt, B., Zimmermann, M., et al.[2018]

In a randomized trial involving over 1000 children with standard-risk acute lymphoblastic leukemia (ALL), dexamethasone was found to significantly reduce the risk of central nervous system relapses compared to prednisone, with a 6-year relapse rate of 3.7% versus 7.1%.

The study also showed that dexamethasone improved event-free survival rates at 6 years (85%) compared to prednisone (77%), indicating that dexamethasone may be a more effective treatment option in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone versus prednisone and daily oral versus weekly intravenous mercaptopurine for patients with standard-risk acute lymphoblastic leukemia: a report from the Children's Cancer Group. Bostrom, BC., Sensel, MR., Sather, HN., et al.[2021]

Dexamethasone (DEX) is more effective than prednisone (PRED) in reducing the risk of serious events in children with acute lymphoblastic leukemia (ALL), including central nervous system relapse, based on a meta-analysis of eight studies.

However, DEX is associated with a higher risk of severe side effects, such as increased mortality during induction therapy and neuro-psychiatric issues, raising concerns about its overall safety despite its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone versus prednisone for induction therapy in childhood acute lymphoblastic leukemia: a systematic review and meta-analysis. Teuffel, O., Kuster, SP., Hunger, SP., et al.[2018]

In a study involving 325 adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, treatment with dexamethasone did not result in better event-free survival compared to prednisolone, with 6-year rates of 25.9% and 28.7% respectively.

Both treatments led to similar rates of complete remission (80.4% for dexamethasone and 76.5% for prednisolone), indicating that dexamethasone does not provide a significant therapeutic advantage over prednisolone in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group. Labar, B., Suciu, S., Willemze, R., et al.[2021]

In a study of 28 adults with malignant lymphoma, treatment with desamethasone led to a partial remission in 13 patients, indicating its potential efficacy in certain cases of lymphoma.

Patients who responded to glucocorticoid treatment had more glucocorticoid receptors on their lymphoma cells and showed greater sensitivity to glucocorticoids in laboratory tests, suggesting that receptor levels could help identify which patients might benefit from glucocorticoid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-vitro glucocorticoid studies for predicting response to glucocorticoid therapy in adults with malignant lymphoma. Bloomfield, CD., Smith, KA., Peterson, BA., et al.[2019]

Citations

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Evidence-based exercises intervention in adults diagnosed ... 18-weeks High-intensity resistance and interval training ex's. No exercise intervention, 86% patients showed up in average of 10 sessions of supervised exercise ...

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Feasibility and preliminary efficacy of a physical activity ... Implementing a tailored PAI in adults with lymphoma during active treatment is feasible, was well received by participants and shows preliminary efficacy.

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Safety and feasibility of exercise interventions in patients with ... Exercise appears to be safe and feasible in hematological cancer patients. However, due to a striking lack of information on how the feasibility of the ...

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Safety and feasibility of exercise interventions in patients ... Exercise appears to be safe and feasible in hematological cancer patients. However, due to a striking lack of information on how the feasibility of the ...

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Changes in physical fitness in acute leukemia patients ... Previous research has shown that exercise interventions can be safe and effective in improving patients' fitness levels with AL. Aerobic ...