Understanding the importance of adipokines in patients with lymphoma (blood cancer) in the clinical setup

Completed

Conditions: Other specified types of non-Hodgkin lymphoma,

Registration Number: CTRI/2021/01/030799

Lead Sponsor: JAMIA HAMDARD

Brief Summary: INTRODUCTION-

Non-Hodgkin lymphomas (NHLs), the main representatives (90%) of lymphomas, encompass a heterogeneous group of lymphoproliferative neoplasms that may arise from B- (80â€“90% of the cases), T- or NK cells at various stages of differentiation. NHLs typically arise in lymphoid tissues (lymph nodes, spleen or bone marrow), although they can develop in any tissue.

The 2016 World Health Organization (WHO) classification of Lymphoid Neoplasms distinguishes over 80 different types of NHLs, based on combined morphological, immunophenotypical, clinical, genetic and aetiological data. The most common types are the relatively aggressive diffuse large B cell lymphoma (DLBCL) and the relatively indolent follicular lymphoma (FL), representing ~35 and ~20% of all NHLs, respectively.

Adipokines are the cytokines which are secreted by the adipose tissue and they act through a network of autocrine, endocrine and paracrine pathway to regulate several aspects of physiology, including glucose and lipid metabolism, neuroendocrine function, cardiovascular function etc.

As not much is known about the association of adipokine with the metabolic disorders in NHL patients, so further studies need to be conducted to explore this area of research.

QoL is typically viewed as a multidimensional concept which includes information regarding individualsâ€™ existing physical symptoms, general health perceptions along with the information regarding physical, emotional, occupational and interpersonal functioning and with long-term disease-free survival following the treatment for B cell Non-Hodgkinâ€™s Lymphoma, Along with the QoL, neurobehavioral changes should also be assessed as they have a direct impact on patientâ€™s well-being.

**AIMS AND OBJECTIVES**

PRIMARY OBJECTIVE(S):

Â·        To assess the role of adipokines physiological processes in B cell Non-Hodgkinâ€™s Lymphoma patients.

SECONDARY OBJECTIVE(S):

Â·        To compare the demographic characteristics of Non-Hodgkin lymphoma patients with healthy human volunteers

Â·        To assess the serum levels of adiponectin, omentin, IL-6 and TNF-alpha in patients with Non-Hodgkin Lymphoma patients and their comparison with healthy human volunteers

Â·        To assess the neurobehavior in patients with Non-Hodgkin Lymphoma patients and their comparison with healthy human volunteers

Â·        To assess the quality of life in patients with Non-Hodgkin Lymphoma patients and their comparison with healthy human volunteers

    **METHODOLOGY**

Subjects will be selected on the basis of given selection criteria:

Â·   **Inclusion Criteria:**

1.       Patient must be 18-65 years old.

2.       Patient must be newly diagnosed with Non-Hodgkinâ€™s Lymphoma either by pathology or cytology

3.       Both males and female patients.

4.       Patient capable of giving informed consent

5.       Patient willing to participate in the study

6.       Patient capable of understanding either Hindi or English

7.       Patient having a Body Mass Index (BMI) of less than 30

Â·   **Exclusion Criteria**

1.       Patients having a history of cognitive impairment and Alzheimerâ€™s disease.

2.       Patients having a history of head injury, organ failure and organ transplant

3.       Patients having any secondary cancer

4.       Patients having neuropsychiatric disorders, neurological and

5.       neurobehavioral diseases

6.       Patients on any psychotropic medications

7.       Patients having a history of drug and alcohol abuse

8.       Patients using any concurrent medication like cholinergic drugs, antidepressants, anti-inflammatory drugs or analgesics.

9.       Lactating or pregnant patients

10. Patients not taking adequate contraception

Â·   **Quality of Life and Behavioural Assessment:**

1.Quality of life and behavioural assessment of patients will be done at baseline and compared to healthy human volunteers. Quality of Life assessment will be done using ***EORTC QLQ*****-*C30 ( Hindi and English)***

***2.*** Depressive state will be determined by **Patient Health Questionnaire (PHQ) PHQ-9**

*3. Cognitive function will be assessed using* **Montreal Cognitive Assessment Scale (MoCA)**

Â·   **Biochemical Assessment**

Serum adipokine levels will be assessed at baseline and compared to healthy human volunteers.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 31

Inclusion Criteria

1.Patient who are 18-65 years old 2.Patients who were diagnosed with B -cell NHL either by pathology or cytology (only newly diagnosed) 3.Both genders.
4.Patient capable of giving informed consent 5.Patient willing to participate in the study 6.Patients having Body Mass Index (BMI) less than 30 7.Patient capable of understanding either Hindi or English 7.Patient capable of understanding either Hindi or English.

Exclusion Criteria

â€¢Exclusion Criteria:.
1.Patients having a history of cognitive impairment and Alzheimerâ€™s disease. 2.Patients having a history of head injury, organ failure and organ transplant 3.Patients having any secondary cancer 4.Patients having neuropsychiatric disorders, neurological and neurobehavioral diseases 5.Patients on any psychotropic medications 6.Patients having a history of drug and alcohol abuse 7.Patients using any concurrent medication like cholinergic drugs, antidepressants, anti-inflammatory drugs or analgesics 8.Lactating or pregnant patients 9.Patients not taking adequate contraception.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the role of adipokines in physiological processes in B cell Non-Hodgkinâ€™s Lymphoma patients	One time point at baseline before first cycle of chemotherapy

Secondary Outcome Measures

Name	Time	Method
To compare the demographic characteristics of Non-Hodgkins Lymphoma patients with healthy human volunteers	2.To compare the neurobehaviour and quality of life of NHL patients with healthy human volunteers

Trial Locations

Locations (1): RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE
🇮🇳
West, DELHI, India
RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE
🇮🇳West, DELHI, India
Dr Dinesh Bhurani
Principal investigator
9971500861
bhurani125@gmail.com