Physical Activity for Myeloma Autograft Longitudinal Study (PAMAL)

Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Physical Activity; Multiple Myeloma
• Intervention / Treatment: Behavioral: Physical exercises; Behavioral: Optional physical exercises

Detailed Description

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. This multicentre 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. The hypothesis of this study is that a supervised physical exercises program during and after autograft might have a positive impact on the physical capacities and the quality of life.

In the experimental arm, 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. In the controlled arm, patients will be hospitalized in the same conditions than the experimental group and can practice if they want. At the end of the hospitalization, they will receive a paper document with global informations about physical exercises including a few simple exercises. Evaluations will be carried out in both arms at day 0, day 30 and day 90 from autograft. The post graft follow up will be done at the same time as the medical consultation and before the maintenance treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quentin Vacandare, Pr; Phone Number: (33)322456443; Email: vacandare.quentin@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physical exercise arm; 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; 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.
ACTIVE_COMPARATOR: controlled arm; 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; patients will be proposed for the physical exercises and will practice them if they want.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of fatigue evaluated by Piper scale	The Piper Fatigue Scale is composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue. This will give an average score that remains on the same "0" to "10"numeric scale. O is the moderate score and 10 is the worst score.	at day 0 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale	The Piper Fatigue Scale is composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue. This will give an average score that remains on the same "0" to "10"numeric scale. O is the moderate score and 10 is the worst score.	at day 30 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale	The Piper Fatigue Scale is composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue. This will give an average score that remains on the same "0" to "10"numeric scale. O is the moderate score and 10 is the worst score.	at day 90 from autograft as patient will be hospitalized.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; University Hospital, Caen
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; quality of life; multiple myeloma; autologous stem cell transplantation; physical conditioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: PI2018_843_0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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