Breast Cancer, Fatigue
Conditions
Keywords
Qiseng, food supplement
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
Interventions
DIETARY_SUPPLEMENTQISENG
2 capsules/day for 8 weeks.
DIETARY_SUPPLEMENTPLACEBO
2 capsules/day for 8 weeks.
Sponsors
NATSUCA laboratory
Groupement Interrégional de Recherche Clinique et d'Innovation
Centre Francois Baclesse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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 (trastuzumab, bevacizumab…) is allowed before and/or during the study (except for pembrolizumab, abemaciclib and PARP inhibitors, which are not authorized) * 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 or gynecological cancer * Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab or PARP inhibitors * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score change [min :5; max:20] | After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of treatment-related adverse events | up to 8 weeks after the end of treatment | The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred |
| Quality of life level assessed by EORTC QLQ-C30 questionnaire | 4 and 8 weeks of treatment and 4 weeks after the end of treatment | EORTC QLQ-C30 quality of life questionnaire scores |
| anxiety level | after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment | HADS anxiety and depression questionnaire scores |
| Other dimensions of fatigue [min :12; max:48] | after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment | Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire |
| Physical activity level | after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment | measured by the IPAQ questionnaire scores |
| Sleep quality | after 4 and 8 weeks of treatment and 4 weeks after the end of treatment | measured by CAT-sleep questionnaire scores |
| The level of acceptability of the treatment, | over a period of 8 weeks | measured by the total number of times the treatment was taken |
| Cognitive function | after 4 and 8 weeks of treatment and 4 weeks after the end of treatment | Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire, |
Countries
France
Contacts
Primary ContactCarine SEGURA, MD
Backup ContactAlexandra LECONTE
Outcome results
None listed