Physical Activity for Myeloma Autograft Longitudinal Study (PAMAL)
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| ClinicalTrials.gov Identifier: NCT03946332 |
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Recruitment Status :
Recruiting
First Posted : May 10, 2019
Last Update Posted : November 9, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Physical Activity Multiple Myeloma Quality of Life | Behavioral: Physical exercises Behavioral: Optional physical exercises | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study. |
| Actual Study Start Date : | May 1, 2019 |
| Actual Primary Completion Date : | May 1, 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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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
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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. |
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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.
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Behavioral: Optional physical exercises
patients will be proposed for the physical exercises and will practice them if they want. |
- Measure of quality of life with EORTC QLQ-C30 questionnaire [ Time Frame: at day 0 from autograft as patient will be hospitalized. ]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.
- Measure of quality of life with EORTC QLQ-C30 questionnaire [ Time Frame: at day 30 from autograft as patient will be hospitalized. ]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.
- Measure of quality of life with EORTC QLQ-C30 questionnaire [ Time Frame: at day 90 from autograft as patient will be hospitalized. ]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.
- Measure of quality of life with QLQ-MY20 questionnaire [ Time Frame: at day 0 from autograft as patient will be hospitalized. ]
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.
- Measure of quality of life measured with QLQ-MY20 questionnaire [ Time Frame: at day 30 from autograft as patient will be hospitalized. ]
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.
- Measure of quality of life measured with QLQ-MY20 questionnaire [ Time Frame: at day 90 from autograft as patient will be hospitalized. ]
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.
- Measure of fatigue evaluated by Piper scale [ Time Frame: at day 0 from autograft as patient will be hospitalized. ]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.
- Measure of fatigue evaluated by Piper scale [ Time Frame: at day 30 from autograft as patient will be hospitalized. ]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.
- Measure of fatigue evaluated by Piper scale [ Time Frame: at day 90 from autograft as patient will be hospitalized. ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946332
| Contact: Marie Beaumont, MD | (33)322455914 | beaumont.marie@chu-amiens.fr | |
| Contact: Quentin Vacandare, Pr | (33)322456443 | vacandare.quentin@chu-amiens.fr |
| France | |
| CHU Amiens | Recruiting |
| Amiens, France, 80054 | |
| 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 |
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT03946332 |
| Other Study ID Numbers: |
PI2018_843_0008 |
| First Posted: | May 10, 2019 Key Record Dates |
| Last Update Posted: | November 9, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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physical activity multiple myeloma autologous stem cell transplantation quality of life physical conditioning |
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |