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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. A nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.

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.

What data supports the effectiveness of the drug dexamethasone for leukemia/lymphoma?

Research shows that dexamethasone is more effective than prednisone in reducing central nervous system relapses and improving event-free survival in children with acute lymphoblastic leukemia, although it may cause more side effects. ^{1 2 3 4 5}

Is the Nutrition and Exercise Plan for Leukemia/Lymphoma safe for humans?

Dexamethasone, a component of the treatment, is associated with more side effects than prednisone, including a higher risk of neuro-psychiatric issues and muscle weakness, but no significant difference in bone health or infection risk. This suggests that while effective, it may have safety concerns that need to be considered. ^{1 2 6 7 8}

How does the drug Dexamethasone differ from other treatments for leukemia/lymphoma?

Dexamethasone may be more effective than prednisone in preventing central nervous system relapses in leukemia/lymphoma, but it can also lead to more severe side effects. This drug is often used in combination with a nutrition and exercise plan to manage side effects like muscle weakness and changes in eating behavior. ^{1 3 6 7 9}

Research Team

Joya Chandra

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. United States 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Dexamethasone versus prednisone for induction therapy in childhood acute lymphoblastic leukemia: a systematic review and meta-analysis. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

Results and conclusions of the European Intergroup EURO-LB02 trial in children and adolescents with lymphoblastic lymphoma. [2018]

4. Italy 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

In-vitro glucocorticoid studies for predicting response to glucocorticoid therapy in adults with malignant lymphoma. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Acute lymphoblastic leukemia and obesity: increased energy intake or decreased physical activity? [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Eating behavior during dexamethasone treatment in children with acute lymphoblastic leukemia. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

No difference between prednisolone and dexamethasone treatment in bone mineral density and growth in long term survivors of childhood acute lymphoblastic leukemia. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Physical frailty deteriorates after a 5-day dexamethasone course in children with acute lymphoblastic leukemia, results of a national prospective study. [2023]