Clinical TrialID 1343
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer (QISEIN)
NCT05241405
Breast Cancer|Fatigue
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1343
- Evidence Id
- 1343
- Core Evidence Id
- 1343
- Source Clinical Trial Id
- 1321
- Herb2 Clinical Trial Id
- HBCT001321
- Nct Id
- NCT05241405
- Title
- Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer (QISEIN)
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- Breast Cancer|Fatigue
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DIETARY_SUPPLEMENT: QISENG|DIETARY_SUPPLEMENT: PLACEBO
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Adult, Older_Adult
- Enrollment
- 354
- Outcome Measure
- Fatigue score change [min :5; max:20], 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, After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
- Sponsor Collaborator
- Centre Francois Baclesse|NATSUCA laboratory|Groupement Interrégional de Recherche Clinique et d'Innovation
- Funded By
- OTHER
- Location
- ARCOCEA_Clinique Europe, Amiens, France|Ch Bayeux, Bayeux, France|Centre Pierre Curie, Beuvry, France|Centre François Baclesse, Caen, France|Polyclinique du Parc, Caen, France|Ch Calais, Calais, France|Ch Cherbourg, Cherbourg, France|Clinique de Flandre, Coudekerque-Branche, France|Centre Henri Becquerel, Rouen, France|Clinique des Dentellières, Valenciennes, France
- Other Id
- 2021-A01550-41
- Start Date
- 2022-09-27
- Primary Completion Date
- 2027-09
- Completion Date
- 2027-09
- First Posted
- 2022-02-15
- Results First Posted
- Last Update Posted
- 2024-10-01
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05241405
- Title Cn
- Title En
- Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer (QISEIN)
- Bilingual Status
- semi_complete