NCT04630275

Brief Summary

This study is an observational cross-sectional study which aims to investigate the relationship between treatment with chemotherapy and the development of low levels of testosterone in the blood in patients cured for aggressive lymphoma. We hypothesize that patients in turn will develop sexual dysfunction and poor quality of life because of this reduced level of testosterone. Cancer treatment is increasingly effective and the overall survival higher, which makes issues like sexuality and long-term quality of life more and more important to address in cured cancer patients. Patient sexuality and quality of life is measured by 3 questionnaires filled out once, and serum testosterone by a single blood sample. If serum testosterone is in the lower part of the normal reference interval, patients will be offered further hormonal evaluation by department of growth and reproduction at Copenhagen University Hospital. We hope to show that future follow up visits should include focus on sexuality and serum testosterone. Questionnaires and blood samples can be implemented easily and without great cost.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

July 27, 2020

Last Update Submit

April 24, 2023

Conditions

Hypogonadism

Keywords

lymphomaDiffuse Large B-Cell LymphomaHodgkinhypogonadismtestosteroneEORTCQuality of lifeSexualitySexual healthCancerIIEF-5DoxorubicinanthracyclineLeydig cellsHypothalamusadriamycin

Outcome Measures

Primary Outcomes (1)

  • Serum-testosterone level

    The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.

    At inclusion

Secondary Outcomes (16)

  • Frequency of co-morbidity according to Cumulative Illness Rating Scale (CIRS) score

    At inclusion

  • Frequency of Erectile Function according to International Index of Erectile Function (IIEF-5)

    At inclusion

  • Level of sexual dysfunction symptoms

    At inclusion

  • Level of sexual function

    At inclusion

  • Level of Quality of life, functioning

    At inclusion

  • +11 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWill be based on social security number
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cohort of patients with Hodgkin Lyphoma or Diffuse Large B-Cell Lymphoma diagnosed during the period April 2008- April 2018 at the Departments of Hematology, Herlev Hospital, Copenhagen University Hospital and Zealand University Hospital, will be identified through The Danish Lymphoma registry (LyFo).

You may qualify if:

  • Age 18-65 years at follow-up
  • Male
  • Verified diagnosis of de novo DLBCL or classical HL diagnosed between April 2008 and April 2018 according to WHO classification.
  • Literate in Danish

You may not qualify if:

  • Concurrent low-grade lymphoma
  • Current or prior lymphoproliferative disease of the central nervous system (CNS)
  • Current or prior lymphoproliferative disease of the testes
  • Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures.
  • Treatment with second line chemotherapy or high dose therapy.
  • Current or prior anabolic steroid drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

HypogonadismLymphomaLymphoma, Large B-Cell, DiffuseSexualityNeoplasms

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

July 27, 2020

First Posted

November 16, 2020

Study Start

December 1, 2020

Primary Completion

April 24, 2023

Study Completion

April 24, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

DK(3)