Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer - Randomized, Placebo-controlled, Double-blind Study

Conditions
-----------------
Breast Cancer, Fatigue

Intervention / Treatment
-----------------
* Dietary Supplement: QISENG
* Dietary Supplement: PLACEBO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with localized breast cancer treated with adjuvant and/or neoadjuvant chemotherapy and adjuvant radiotherapy. These treatments must be completed within 4 weeks prior to inclusion 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 Maintenance therapy with hormone therapy or other maintenance therapy (except Pembrolizumab) is allowed before and/or during the study Patient 18 years of age or older Effective contraception in women of childbearing age Patient affiliated to a social security plan Signed informed consent Exclusion Criteria: Other identified causes of fatigue (anemia of grade > 2, underlying chronic disease known to be associated with fatigue) Ongoing chemotherapy (patients scheduled for oral capecitabine or trastuzumab-emtasin in the adjuvant setting are not eligible) Metastatic breast cancer Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab Patient requiring oral diabetes therapy Regular intake of Vitamin C (in addition to what is provided by the diet) Patients with chronic pain requiring daily treatment with analgesics, anti-inflammatory drugs or corticosteroids Consumption of ginseng-based products in the month prior to inclusion Hypersensitivity to any of the components of Qiseng or placebo Pregnant or breastfeeding patient Simultaneous participation in another therapeutic clinical trial (trial using an experimental product) Patient deprived of liberty, under guardianship or curatorship Patient unable to undergo the medical follow-up of the trial for geographical, social or psychopathological reasons 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qiseng<br>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 | Dietary Supplement: QISENG<br>* 2 capsules/day for 8 weeks.<br>|
| Placebo Comparator: Placebo<br>neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract | Dietary Supplement: PLACEBO<br>* 2 capsules/day for 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other dimensions of fatigue [min :12; max:48] | Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire | after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment | 
| The incidence of treatment-related adverse events | The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred | up to 8 weeks after the end of treatment | 
| Quality of life level assessed by EORTC QLQ-C30 questionnaire | EORTC QLQ-C30 quality of life questionnaire scores | 4 and 8 weeks of treatment and 4 weeks after the end of treatment | 
| anxiety level | HADS anxiety and depression questionnaire scores | after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment | 
| Cognitive function | Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire, | after 4 and 8 weeks of treatment and 4 weeks after the end of treatment | 
| Physical activity level | measured by the IPAQ questionnaire scores | after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment | 
| Sleep quality | measured by CAT-sleep questionnaire scores | after 4 and 8 weeks of treatment and 4 weeks after the end of treatment | 
| The level of acceptability of the treatment, | measured by the total number of times the treatment was taken | over a period of 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Qiseng, food supplement