Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05241405
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2022-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 354}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue score change [min :5; max:20]', 'timeFrame': 'After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)', 'description': 'The difference between the initial (inclusion) score and the best score based on EORTC QLQ-FA12 questionnaire (physical fatigue dimension) between assessments at 1 week (S9) and 4 weeks (S12) after the end of treatment) will be calculated'}], 'secondaryOutcomes': [{'measure': 'Other dimensions of fatigue [min :12; max:48]', 'timeFrame': 'after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment', 'description': 'Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire'}, {'measure': 'The incidence of treatment-related adverse events', 'timeFrame': 'up to 8 weeks after the end of treatment', 'description': 'The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred'}, {'measure': 'Quality of life level assessed by EORTC QLQ-C30 questionnaire', 'timeFrame': '4 and 8 weeks of treatment and 4 weeks after the end of treatment', 'description': 'EORTC QLQ-C30 quality of life questionnaire scores'}, {'measure': 'anxiety level', 'timeFrame': 'after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment', 'description': 'HADS anxiety and depression questionnaire scores'}, {'measure': 'Cognitive function', 'timeFrame': 'after 4 and 8 weeks of treatment and 4 weeks after the end of treatment', 'description': 'Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,'}, {'measure': 'Physical activity level', 'timeFrame': 'after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment', 'description': 'measured by the IPAQ questionnaire scores'}, {'measure': 'Sleep quality', 'timeFrame': 'after 4 and 8 weeks of treatment and 4 weeks after the end of treatment', 'description': 'measured by CAT-sleep questionnaire scores'}, {'measure': 'The level of acceptability of the treatment,', 'timeFrame': 'over a period of 8 weeks', 'description': 'measured by the total number of times the treatment was taken'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qiseng', 'food supplement'], 'conditions': ['Breast Cancer', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with localized breast or gynecological cancer treated as curative adjuvant and/or neoadjuvant chemotherapy and/or adjuvant radiotherapy. These treatments must have been completed within 6 months of inclusion.\n\n * Patient reporting a chronic, stable fatigue state at investigator assessment, defined as a fatigue score ≥ 4 on the visual analog scale rated up to 10, experienced for at least one month\n * Maintenance therapy with hormone therapy or other maintenance therapy (trastuzumab, bevacizumab…) is allowed before and/or during the study (except for pembrolizumab, abemaciclib and PARP inhibitors, which are not authorized)\n * Patient 18 years of age or older\n * Effective contraception in women of childbearing age\n * Patient affiliated to a social security plan\n * Signed informed consent\n\nExclusion Criteria:\n\n* Other identified causes of fatigue (anemia of grade \\> 2, underlying chronic disease known to be associated with fatigue)\n* Ongoing chemotherapy (patients scheduled for oral capecitabine or trastuzumab-emtasin in the adjuvant setting are not eligible)\n* Metastatic breast or gynecological cancer\n* Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab or PARP inhibitors\n* Patient requiring oral diabetes therapy\n* Regular intake of Vitamin C (in addition to what is provided by the diet)\n* Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids\n* Consumption of ginseng-based products in the month prior to inclusion\n* Hypersensitivity to any of the components of Qiseng or placebo\n* Pregnant or breastfeeding patient\n* Simultaneous participation in another therapeutic clinical trial (trial using an experimental product)\n* Patient deprived of liberty, under guardianship or curatorship\n* Patient unable to undergo the medical follow-up of the trial for geographical, social or psychopathological reasons\n* History of any other malignant disease during the last 3 years, except for skin cancer other than melanoma, carcinoma in situ of the uterus. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no signs of recurrence for at least 3 years'}, 'identificationModule': {'nctId': 'NCT05241405', 'acronym': 'QISEIN', 'briefTitle': 'Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer - Randomized, Placebo-controlled, Double-blind Study', 'orgStudyIdInfo': {'id': '2021-A01550-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qiseng', 'description': '200 mg/capsule of P. quinquefolius extract, i.e. 30 mg of ginsenosides, associated with 30 mg of vitamin C extracted from Camu Camu berry', 'interventionNames': ['Dietary Supplement: QISENG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract', 'interventionNames': ['Dietary Supplement: PLACEBO']}], 'interventions': [{'name': 'QISENG', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules/day for 8 weeks.', 'armGroupLabels': ['Qiseng']}, {'name': 'PLACEBO', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules/day for 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel GOSY, MD', 'role': 'CONTACT'}], 'facility': 'ARCOCEA_Clinique Europe', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Bayeux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre-Emmanuel BRACHET, MD', 'role': 'CONTACT'}], 'facility': 'Ch Bayeux', 'geoPoint': {'lat': 49.27732, 'lon': -0.7039}}, {'city': 'Beuvry', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Briac PREVOST, MD', 'role': 'CONTACT'}], 'facility': 'Centre Pierre Curie', 'geoPoint': {'lat': 50.51674, 'lon': 2.68541}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carine SEGURA, MD', 'role': 'CONTACT', 'email': 'c.segura@baclesse.unicancer.fr'}], 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel SEVIN, MD', 'role': 'CONTACT'}], 'facility': 'Polyclinique du Parc', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Calais', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fatima MENIAI, MD', 'role': 'CONTACT'}], 'facility': 'Ch Calais', 'geoPoint': {'lat': 50.95194, 'lon': 1.85635}}, {'city': 'Cherbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure KALUZINSKI, MD', 'role': 'CONTACT'}], 'facility': 'Ch Cherbourg', 'geoPoint': {'lat': 49.63984, 'lon': -1.61636}}, {'city': 'Coudekerque-Branche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste AISENFARB, MD', 'role': 'CONTACT'}], 'facility': 'Clinique de Flandre', 'geoPoint': {'lat': 51.02288, 'lon': 2.39359}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier RIGAL, MD', 'role': 'CONTACT'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Valenciennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JESSICA GROSJEAN, MD', 'role': 'CONTACT'}], 'facility': 'Clinique des Dentellières', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'centralContacts': [{'name': 'Carine SEGURA, MD', 'role': 'CONTACT', 'email': 'c.segura@baclesse.unicancer.fr', 'phone': '+33231455050'}, {'name': 'Alexandra LECONTE', 'role': 'CONTACT', 'email': 'a.leconte@baclesse.unicancer.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'NATSUCA laboratory', 'class': 'UNKNOWN'}, {'name': "Groupement Interrégional de Recherche Clinique et d'Innovation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}