Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer (RE-NEZ-SENS)

January 15, 2026 updated by: University Hospital, Montpellier
Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with chemotherapy for Haematological Cancer, and also improve their life quality, psychological well-being, and nutrition.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Disturbances in taste and smell affect a considerable proportion of patients treated with chemotherapy. In hematology, dysgeusia depends on the type pathology and the treatments themselves. It impacts the quality of life, leads to significant emotional and social consequences, affects the intake, weight and nutritional status of patients.

Olfactory-taste disorders can be assessed using subjective and objective tests. There are no international clinical recommendations for the management of taste and olfactory disturbances associated with chemotherapy in hematological cancers. Also, this study proposes to evaluate a taste and olfaction rehabilitation program based on national standards and recent research. It will help fill gaps in the assessment and management of patients treated for Haematological cancer.

Hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with Chemotherapy for Haematological cancer and significantly improve their quality of life, their psychological well-being and their nutrition.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34 295
        • Hematology Department, University Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and ≤ 75 years old
  • Patient with olfactory or gustatory disorders
  • Patient who has completed chemotherapy for haematological cancer

Exclusion Criteria:

  • Eating disorder known prior to anti-cancer treatment, bulimic, anorexic or binge eating disorder (DSM-V criteria)
  • Refusal to sign the free and informed consent
  • Hypersensitivity to one of the components of liposomal sprays (Liposaliva® or liponasal®)
  • COVID + patient in the previous 3 months
  • Performance status ECOG 3 or 4
  • Patient included in another clinical trial modifying taste / olfaction
  • Artificial nutrition post-chemotherapy
  • Known food allergies
  • Having a reading level in French that may interfere with a good understanding of the protocol and the questionnaires
  • Presenting visual or hearing deficits uncorrected to normal and which may affect the proper completion of the questionnaires
  • Patient under curatorship or tutorship.
  • Patient deprived of liberty
  • Pregnant or breastfeeding patient
  • Not be affiliated with a French social security scheme or beneficiary of such a scheme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional

Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes.

The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate a minimum of 2 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation.

Exercises (taking up the themes discussed) will be carried out at home between 2 workshops.
Other: Multifactorial sensory rehabilitation workshops
A multifactorial sensory rehabilitation Workshops : a multifactorial program in order to optimize the recovery of flavors, focused on smell and taste which integrates several non-drug interventions, which are part of the current recommendations: hydration of the mucous membranes with daily (3 times a day) liposomal sprays (nose and mouth), presentation of visual dishes.
Other: Tests and Questionnaire
fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients
Other: Control

The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat.

The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.

Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study.
Other: Usual care

The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat.

The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.

Other: Tests and Questionnaire
fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the olfactometry
Time Frame: 3 months
Evolution of the Score of the "Sniffin'sticks" test from the initial score (V0), which itself includes an olfactory discrimination, olfactory threshold and olfactory identification score (with a cut-off of ≤ 15 for anosmia, ≥ for normonosmia and hypoanosmia for a score between 15 and 30)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the gustometry
Time Frame: up to 6 months
Score in the "Taste Strips" test, Hypoageusia scores being for participants aged 18 to 40, <19 for women and <17 for men; for participants aged 41 to 60, score <15 for women and 9 for men; for participants over 60, score <10.2 for women and <9 for men
up to 6 months
Variation of Taste and Smell Survey score
Time Frame: up to 6 months
Variation of the taste and Smell Survey score
up to 6 months
Assessment of the Psychological distress
Time Frame: u pto 6 months
The psychological distress score objectified by the Hospital Anxiety Depression Scale (HADS). This self-questionnaire, validated in French, contains 14 items. It is simple, sensitive and specific. It has been validated in cancer patients, that it is rapid (completion time around 5 minutes), and allows the calculation of 2 sub-scores for anxiety and depression in addition to an overall level. Finally, this tool is sensitive to changes both during the course of medical illnesses and in response to psychopharmacological interventions.
u pto 6 months
Assessment of the physical activity
Time Frame: up to 6 months
assessed by the score at GPAQ scale (Bull, Maslin, & Armstrong, 2009)
up to 6 months
Variation of the patient weight
Time Frame: up to 6 months
assessed by BMI between the beginning and the end of the study
up to 6 months
Assessment of the Quality of life
Time Frame: Up to 6 months
Quality of life scores, obtained on the FACT-G scale. This is a 27-point self-administered questionnaire that measures the quality of life of patients with cancer. The FACT-G measures physical, functional, social / family factors, and emotional well-being as well as physician / patient relationship satisfaction and concerns. All items are rated on a 5-point Likert scale based on the week prior to the assessment.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Franciane PAUL, Dr., UH of Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Actual)

January 14, 2026

Study Completion (Actual)

January 14, 2026

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0187

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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