Clinical trial NCT05241405: Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Fatigue
Keywords: Qiseng
food supplement
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: NATSUCA laboratory
name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2022-02-15
Enrollment: 354
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: Fatigue score change [min :5; max:20]
timeFrame: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Secondary outcomes:
measure: Other dimensions of fatigue [min :12; max:48]
timeFrame: after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment
measure: The incidence of treatment-related adverse events
timeFrame: up to 8 weeks after the end of treatment
measure: Quality of life level assessed by EORTC QLQ-C30 questionnaire
timeFrame: 4 and 8 weeks of treatment and 4 weeks after the end of treatment
measure: anxiety level
timeFrame: after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
measure: Cognitive function
timeFrame: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
measure: Physical activity level
timeFrame: after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
measure: Sleep quality
timeFrame: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
measure: The level of acceptability of the treatment,
timeFrame: over a period of 8 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: ARCOCEA_Clinique Europe
city: Bayeux
country: France
facility: Ch Bayeux
city: Beuvry
country: France
facility: Centre Pierre Curie
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Polyclinique du Parc
city: Calais
country: France
facility: Ch Calais
city: Cherbourg
country: France
facility: Ch Cherbourg
city: Coudekerque-Branche
country: France
facility: Clinique de Flandre
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Valenciennes
country: France
facility: Clinique des Dentellières
Study officials:
References: