Nutrition/diet evaluation for Hematologic Neoplasms

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke University Adult Bone Marrow Transplant Clinic, Durham, NC
Hematologic Neoplasms+1 More
Nutrition/diet evaluation - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Hematologic Neoplasms

Study Summary

This study is evaluating whether a program to improve health before and after a stem cell transplant will improve outcomes.

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Eligible Conditions

  • Hematologic Neoplasms
  • Malignancies, Hematologic

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Nutrition/diet evaluation will improve 1 primary outcome and 31 secondary outcomes in patients with Hematologic Neoplasms. Measurement will happen over the course of 30 days.

1 year
Assessing falls
Caregiver quality of life as assessed by the Caregiver Strain questionnaire
Caregiver support as assessed by the caregiver strain index questionnaire
Cognitive function as assessed by PROMIS cognitive questionnaire
Delirium as measured by the DOS assessment
Disease-free survival
Graft versus host disease (GVHD)
Hospital length of stay
Intensive care unit length of stay
Measuring biomarkers of inflammation/frailty in blood plasma samples
Mental health as assessed by PROMIS depression questionnaire
Overall survival
Physical function as assessed by PROMIS physical function questionnaire
Quality of life as assessed by the FACT-BMT questionnaire
Rate of bacterial infections
Rate of fungal infections
Rate of hospital admission/re-admission
Rate of intensive care unit admission/re-admission
Rate of overall infections
Rate of viral infections
Return to work as assessed by the Work Assessment
Social support as assessed by the PROMIS social isolation questionnaire
Transplant length of stay
30 days
Diet as assessed by the TRU-BMT digital application
Diet as assessed by the food group tracking digital application
Nutrition as assessed by the 24 hour food recall survey
6 months
Number of subjects who complete at least half of their high intensity interval training sessions
Day 0
Changes in fecal samples as measured by 16s rRNA sequencing in caregivers
Changes in fecal samples as measured by 16s rRNA sequencing in transplant patients
Measuring Changes in the skin flora (microbiome) in caregivers
Measuring Changes in the skin flora (microbiome) in transplant patients
day 180
Physical activity as measured by Cardiopulmonary exercise testing (CPET)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Caregiver

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nutrition/diet Evaluation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CaregiverThese are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
PatientThese are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interval training
2011
N/A
~370

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Duke University Adult Bone Marrow Transplant Clinic - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I am planning to have an allogeneic hematopoietic stem cell transplant in the next 6 months for any cancer or non-cancer illness. show original
Age 18-80 years
Patient

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hematologic neoplasms?

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The signs and symptoms of non-Hodgkin lymphomas and Hodgkin disease can vary from person to person. The first symptoms may not be related to symptoms that are specific to the tumor itself. For example, the person may have a fever or feel tired with very little or no history of weight loss, enlargement of the spleen or lymph nodes, bone pain or night sweats. Diagnosis and treatment of non-Hodgkin lymphoma/Hodgkin disease can often be hindered by this presentation.

Unverified Answer

What are common treatments for hematologic neoplasms?

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There is no cure for hematologic neoplasms. Treatment is very dependent on the specific patient; for example, the disease may have been present for a long time without an obvious presentation. Most treatments can be combined in multiple ways in treatment strategy.

Unverified Answer

How many people get hematologic neoplasms a year in the United States?

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Nearly 1 in 6 men in the United States could develop a hematologic malignancy. Men in the African-American subgroups had significantly higher than expected risks of all types of hematologic malignancies.

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Can hematologic neoplasms be cured?

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The data suggest that many hematologic neoplasms, including [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia), acute myelogenous leukemia, myelodysplastic syndromes, and acute promyelocytic leukemia, may be highly curable or even vanish without treatment after initial diagnosis, but the chances for remission were low. However, it is not yet possible to draw definite conclusions, since the studies were retrospective and all patients received no curative treatment.

Unverified Answer

What causes hematologic neoplasms?

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Hematopoietic neoplasms are rare and are more common among the elderly. Chronic hepatitis B virus infection is the most common cause of hematopoietic neoplasm. The association of cancer with other diseases such as hepatitis B virus is not well understood. There are no hematologic neoplasms associated with immunodeficiency. The risk of malignancy is greater than that of the general population for disorders of immune function, particularly autoimmune diseases and transplantation.

Unverified Answer

What is hematologic neoplasms?

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Hematologic neoplasms, including all leukemia, lymphoma, and myeloma, are among the most common types of cancers and lead to serious consequences. They affect approximately one in four individuals and are the cause of death in one in four Americans with cancer. Hematologic neoplasms can be caused by genetic and environmental factors.

Unverified Answer

What is the average age someone gets hematologic neoplasms?

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On average, persons diagnosed with a hematologic neoplasm in 1993 will have been 54.6 years old at the time of diagnosis. This is older than the ages of most people without a neoplasm, particularly with regard to the median ages of most other chronic conditions, but is not exceptionally so relative to most other cancers. For more specific purposes, particularly regarding specific hematologic neoplasms, a subset analysis based on exact diagnosis may be more meaningful than, e.g., the overall median age.

Unverified Answer

What is nutrition/diet evaluation?

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In adults with hematologic neoplasms, dietary assessment is not warranted unless there is suspicion of undernutrition. An initial meal intake (or on-demand) of one to two grams of carbohydrate/g body weight/day should be instituted in all patients regardless of stage of disease or body mass index.

Unverified Answer

What does nutrition/diet evaluation usually treat?

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Results from a recent paper indicate that nutrition/diet evaluation can help treat patients with low or low-normal nutritional values of protein intake (<0.8 g/kg) and a higher energy density (<2.0 kcal/g).

Unverified Answer

What is the primary cause of hematologic neoplasms?

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It is clear that other causes exist. The majority of primary hematologic neoplasms are not the result of human papillomavirus infection or genetic alterations in hematological stem cells. Infection with human T-lymphotropic virus types I and II has been postulated an important cause of malignant lymphoproliferative disorders. In addition, infection with Epstein-Barr virus, cytomegalovirus, and human foamyleukocytic leukoproliferative syndrome, have also been implicated.

Unverified Answer

Does hematologic neoplasms run in families?

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Results from a recent paper discloses a significant contribution of MMs to hematologic neoplasms not elsewhere classified, indicating that hematological malignancies are part of a multi-hit syndrome in these hereditary cancers.

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What are the chances of developing hematologic neoplasms?

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The [possible adverse effects of leukemia cells are (1) leukemia cells could penetrate the brain, eye and spine; (2) leukemia cells could be carried to and populate many parts of the body; and (3) leukemia cells could be metastasized and form malignant tumors that may invade various tissues and threaten health. All three of these events are serious threats to hematologic neoplasms.

Unverified Answer
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