Physical Activity for Myeloma Autograft Longitudinal Study

NCT03946332 | Unknown

• 1 other identifier: PI2018_843_0008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.

Conditions

Physical Activity; Multiple Myeloma; Quality of Life

Keywords

physical activity; multiple myeloma; autologous stem cell transplantation; quality of life; physical conditioning

Outcome Measures

Primary Outcomes (6)

• Measure of quality of life with EORTC QLQ-C30 questionnaire

  The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

  at day 0 from autograft as patient will be hospitalized.

• Measure of quality of life with EORTC QLQ-C30 questionnaire

  The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

  at day 30 from autograft as patient will be hospitalized.

• Measure of quality of life with EORTC QLQ-C30 questionnaire

  The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

  at day 90 from autograft as patient will be hospitalized.

• Measure of quality of life with QLQ-MY20 questionnaire

  The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients. QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

  at day 0 from autograft as patient will be hospitalized.

• Measure of quality of life measured with QLQ-MY20 questionnaire

  The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients. QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

  at day 30 from autograft as patient will be hospitalized.

• Measure of quality of life measured with QLQ-MY20 questionnaire

  The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients. QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

  at day 90 from autograft as patient will be hospitalized.

Secondary Outcomes (3)

• Measure of fatigue evaluated by Piper scale

  at day 0 from autograft as patient will be hospitalized.

• Measure of fatigue evaluated by Piper scale

  at day 30 from autograft as patient will be hospitalized.

• Measure of fatigue evaluated by Piper scale

  at day 90 from autograft as patient will be hospitalized.

Study Arms (2)

Physical exercise arm

EXPERIMENTAL

patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice

Behavioral: Physical exercises

controlled arm

ACTIVE COMPARATOR

patients will be hospitalized in the same conditions than the experimental group and will be able to practice if they want.

Behavioral: Optional physical exercises

Interventions

Physical exercises BEHAVIORAL

patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization.

Physical exercise arm

Optional physical exercises BEHAVIORAL

patients will be proposed for the physical exercises and will practice them if they want.

controlled arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Under 65-year-old patient
• more than 18 years old
• Hospitalized for autologous stem cell transplantation
• First or second line therapy for multiple myeloma
• Chemotherapy regimen with melphalan
• Patient affiliated to the social security system
• Signed informed consent form
• Patient who have computer and internet connection at home

You may not qualify if:

• Over-65-year-old patient
• Other haematological malignancies
• More than 2 treatment lines
• Other regimen of chemotherapy for autograft than melphalan
• Contraindication to physical exercises: uncontrolled arterial hypertension or diabetes, heart or respiratory failure, psycho-cognitive disorders that may compromise the physical exercises program
• dialyzed patient
• Adult patient under tutelage

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Rouen: collaborator
• University Hospital, Caen: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Motor Activity; Multiple Myeloma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• caroline delette, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Pierre Morel, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Fabrice Jardin, Pr

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Oana Brehar, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Vincent Camus, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Nathalie Cardinael, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Nathalie Contentin, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Marie-Laure Fontoura, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Carole Fronville Varnier, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Hélène Lanic, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Emilie Lemasle Hue, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Pascal Lenain, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Stéphane Lepretre, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Anna-Lise Menard, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Aspasia Stamatoullas-Bastard, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Hervé Tilly, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Gandhi L Damaj, Pr

  CHU CAEN

  PRINCIPAL INVESTIGATOR

• Stéphane Cheze, MD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

• Margaret Macro, MD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Beaumont, MD

CONTACT

(33)322455914; beaumont.marie@chu-amiens.fr

Quentin Vacandare, Pr

CONTACT

(33)322456443; vacandare.quentin@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)