Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology (ODORAJA)

ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology

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

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Effect; Solid Tumor, Adult; Solid Tumor, Childhood
• Intervention / Treatment: Other: Evaluation on appearance of unpleasant body odors

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Aurélie Thuleau; Phone Number: +33 1 44324228; Email: drci.promotion@curie.fr
• Study Contact Backup: Name: Lobna Saidi; Phone Number: +33 1 72389334; Email: lobna.saidi@curie.Fr

Study Locations

• France
  • Paris, France, 75
    • Recruiting
    • Institut Curie
    • Contact: Aurélie Thuleau; Phone Number: +33 1 44324228; Email: drci.promotion@curie.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients aged between 15 and 25 years with solid tumors

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualification of the smell and the discomfort felt	Answers to the investigation intended for patients for the appearance of the smell with different proposals like sweating, urine, breath etc. (Q2), its qualifier with different proposals like desagreable, infective, nauseating, etc…(Q3) and the discomfort observed for themselves or for those around them (Q8)	8 months
Quantification of the discomfort and the impact on quality of life	Answers to the investigation intended for patients to assess the intensity of the smell with a scale (0= no smell and 10 = strong smell) (Q4), its daily impact with a scale (0=no impact and 10= high impact) (Q7) and solutions that can reduce smell with different proposals like perfume, cream, essential oil (Q9)	8 months
Identify possible causes of the appearance of these new body odors	Answers to the investigation for patients to assess the link between smell and drug treatment with different proposals like treatment, hospital's food or hospital cleaning product (Q5 and Q6)	8 months

Collaborators and Investigators

• Sponsor: Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Anticipated): October 21, 2025
• Study Completion (Anticipated): October 21, 2025

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IC 2021-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No