Lean Body Mass and Side Effects in Patients With Lymphoma | NCT04698616

Studies
Lean Body Mass and Side Effects in Patients With Lymphoma

NCT04698616

Sponsor

Jens Rikardt Andersen

Status

Unknown status

Last Update Posted

Jan 7, 2021Actual

Enrollment

141Estimated

Phase

Not provided

Conditions

Malignant Lymphoma

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2020Actual

Primary Completion Date

Jan 31, 2021Estimated

Completion Date

Mar 3, 2021Estimated

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

Jan 4, 2021

First Posted Date

Jan 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2021

Last Update Posted Date

Jan 7, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jens Rikardt Andersen, Sponsor - Investigator, University of CopenhagenSponsor-Investigator

Lead Sponsor

Jens Rikardt AndersenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary purpose is to investigate the relationship between the dose of chemotherapeutic agents per kilogram of lean body mass (LBM) and the development of side effects induced by chemotherapy in patients with lymphoma. Secondarily, the maximum tolerable dose of chemotherapeutics (MTD), patients' quality of life (QOL), nutritional status and physical activity during the course of treatment are estimated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

141Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Malignant lymphoma patients		Identification of the patients who are/are not dose-reduced due to chemotherapy, and then look at the body composition in connection with this.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lean Body Mass (LBM)	LBM measured by bioelectrical impedans corelated to the dosis of chemotherapeutics given	8 weeks (two treatment cycles)

Secondary Outcomes

Measure	Description	Time Frame
Maximal tolerable dose of chemotherapeutics (microg/ml/kg LBM),	Patients with side effects - correlation between dose of cytostatics/ kg LBM compared to patients without side effects	8 weeks (two treatment cycles)
Quality of life (QOL) (score EORTC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving myelosuppressive treatment for malignant lymphoma assessed by the investigator.
Legal of age

Exclusion Criteria:

ECOG Performance Status ≥2
People who cannot speak and understand Danish
Pregnant and breastfeeding
Dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving myelosuppressive treatment for malignant lymphoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian Bjørn Poulsen, MD, PhD	Contact	+45 47324809		cbpo@regionsjaelland.dk
Jens R Andersen, MD,MPA	Contact	+4523346654		jra@post3.tele.dk

Overall Officials

Name	Affiliation	Role
Jens R Andersen, MD,MPA	University of Copenhagen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen	Completed	Copenhagen	Frederiksberg	1958	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D009043	Motor Activity

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided