Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated fo… (NCT05241405) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
France354 participantsStarted 2022-09-27
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
What they're measuring
1
Fatigue score change [min :5; max:20]
Timeframe: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)