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

Официальное название

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

Обзор

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

Вмешательства

• Пищевая добавка QISENG
  2 capsules/day for 8 weeks.
• Пищевая добавка PLACEBO
  2 capsules/day for 8 weeks.

Первичные конечные точки

• Fatigue score change [min :5; max:20] [Срок оценки: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)]

Вторичные конечные точки (8)

• Other dimensions of fatigue [min :12; max:48] [Срок оценки: 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 [Срок оценки: up to 8 weeks after the end of treatment]
• Quality of life level assessed by EORTC QLQ-C30 questionnaire [Срок оценки: 4 and 8 weeks of treatment and 4 weeks after the end of treatment]
• anxiety level [Срок оценки: after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment]
• Cognitive function [Срок оценки: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment]
• Physical activity level [Срок оценки: after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment]
• Sleep quality [Срок оценки: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment]
• The level of acceptability of the treatment, [Срок оценки: over a period of 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 10 центров

• ARCOCEA_Clinique Europe — Amiens
• Ch Bayeux — Bayeux
• Centre Pierre Curie — Beuvry
• Centre François Baclesse — Caen
• Polyclinique du Parc — Caen
• Ch Calais — Calais
• Ch Cherbourg — Cherbourg
• Clinique de Flandre — Coudekerque-Branche
• … и ещё 2 центра

Идентификаторы

NCT: NCT05241405 · 2021-A01550-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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