Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-02 @ 4:49 PM
Study NCT ID:
NCT03946332
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity for Myeloma Autograft Longitudinal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of quality of life with EORTC QLQ-C30 questionnaire', 'timeFrame': 'at day 0 from autograft as patient will be hospitalized.', 'description': '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': 'Measure of quality of life with EORTC QLQ-C30 questionnaire', 'timeFrame': 'at day 30 from autograft as patient will be hospitalized.', 'description': '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': 'Measure of quality of life with EORTC QLQ-C30 questionnaire', 'timeFrame': 'at day 90 from autograft as patient will be hospitalized.', 'description': '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': 'Measure of quality of life with QLQ-MY20 questionnaire', 'timeFrame': 'at day 0 from autograft as patient will be hospitalized.', 'description': 'The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.\n\nQLQ-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': 'Measure of quality of life measured with QLQ-MY20 questionnaire', 'timeFrame': 'at day 30 from autograft as patient will be hospitalized.', 'description': 'The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.\n\nQLQ-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': 'Measure of quality of life measured with QLQ-MY20 questionnaire', 'timeFrame': 'at day 90 from autograft as patient will be hospitalized.', 'description': 'The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.\n\nQLQ-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.'}], 'secondaryOutcomes': [{'measure': 'Measure of fatigue evaluated by Piper scale', 'timeFrame': 'at day 0 from autograft as patient will be hospitalized.', 'description': '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': 'Measure of fatigue evaluated by Piper scale', 'timeFrame': 'at day 30 from autograft as patient will be hospitalized.', 'description': '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': 'Measure of fatigue evaluated by Piper scale', 'timeFrame': 'at day 90 from autograft as patient will be hospitalized.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'multiple myeloma', 'autologous stem cell transplantation', 'quality of life', 'physical conditioning'], 'conditions': ['Physical Activity', 'Multiple Myeloma', 'Quality of Life']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Under 65-year-old patient\n* more than 18 years old\n* Hospitalized for autologous stem cell transplantation\n* First or second line therapy for multiple myeloma\n* Chemotherapy regimen with melphalan\n* Patient affiliated to the social security system\n* Signed informed consent form\n* Patient who have computer and internet connection at home\n\nExclusion Criteria:\n\n* Over-65-year-old patient\n* Other haematological malignancies\n* More than 2 treatment lines\n* Other regimen of chemotherapy for autograft than melphalan\n* Contraindication to physical exercises: uncontrolled arterial hypertension or diabetes, heart or respiratory failure, psycho-cognitive disorders that may compromise the physical exercises program\n* dialyzed patient\n* Adult patient under tutelage'}, 'identificationModule': {'nctId': 'NCT03946332', 'acronym': 'PAMAL', 'briefTitle': 'Physical Activity for Myeloma Autograft Longitudinal Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.', 'orgStudyIdInfo': {'id': 'PI2018_843_0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical exercise arm', 'description': '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', 'interventionNames': ['Behavioral: Physical exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'controlled arm', 'description': 'patients will be hospitalized in the same conditions than the experimental group and will be able to practice if they want.', 'interventionNames': ['Behavioral: Optional physical exercises']}], 'interventions': [{'name': 'Physical exercises', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Physical exercise arm']}, {'name': 'Optional physical exercises', 'type': 'BEHAVIORAL', 'description': 'patients will be proposed for the physical exercises and will practice them if they want.', 'armGroupLabels': ['controlled arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Marie Beaumont, MD', 'role': 'CONTACT', 'email': 'beaumont.marie@chu-amiens.fr', 'phone': '(33)322455914'}, {'name': 'Quentin Vacandare, Pr', 'role': 'CONTACT', 'email': 'vacandare.quentin@chu-amiens.fr', 'phone': '(33)322456443'}], 'overallOfficials': [{'name': 'caroline delette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Pierre Morel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'Fabrice Jardin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Oana Brehar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Vincent Camus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Nathalie Cardinael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Nathalie Contentin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Marie-Laure Fontoura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Carole Fronville Varnier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Hélène Lanic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Emilie Lemasle Hue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Pascal Lenain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Stéphane Lepretre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Anna-Lise Menard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Aspasia Stamatoullas-Bastard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Hervé Tilly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}, {'name': 'Gandhi L Damaj, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU CAEN'}, {'name': 'Stéphane Cheze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU CAEN'}, {'name': 'Margaret Macro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU CAEN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Rouen', 'class': 'OTHER'}, {'name': 'University Hospital, Caen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}