NCT04899505

Brief Summary

The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed
Last Updated

May 16, 2025

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

May 19, 2021

Last Update Submit

May 14, 2025

Conditions

Solid Tumor, AdultSolid Tumor, ChildhoodChemotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • Incidence of the development of unpleasant body odors in AYA oncology patients

    Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department

    8 months

Secondary Outcomes (3)

  • Qualification of the smell and the discomfort felt

    8 months

  • Quantification of the discomfort and the impact on quality of life

    8 months

  • Identify possible causes of the appearance of these new body odors

    8 months

Study Arms (1)

Evaluation on appearance of unpleasant body odors

Incidence of the development of unpleasant body odors in AYA oncology patients

Other: Evaluation on appearance of unpleasant body odors

Interventions

Evaluation on appearance of unpleasant body odorsOTHER

Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department.

Evaluation on appearance of unpleasant body odors

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients aged between 15 and 25 years with solid tumors

You may qualify if:

  • Patients aged between 15 and 25 years;
  • New patients treated at the Curie Institute and hospitalized in the AJA oncology department;
  • Patient undergoing chemotherapy administered intravenously;
  • Solid tumors.

You may not qualify if:

  • Patient undergoing oral chemotherapy;
  • Persons deprived of their liberty or under guardianship (including guardianship);
  • Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

October 21, 2021

Primary Completion

May 12, 2025

Study Completion

May 12, 2025

Last Updated

May 16, 2025

Record last verified: 2023-01

Locations

FR(1)