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

Not Applicable

Recruiting

• Conditions: Fatigue; Breast Cancer
• Interventions: Dietary Supplement: QISENG; Dietary Supplement: PLACEBO

• Registration Number: NCT05241405
• Lead Sponsor: Centre Francois Baclesse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-15
• Study Start: 2022-09-27
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qiseng	QISENG	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
Placebo	PLACEBO	neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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,
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
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
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
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

Trial Locations

Locations (10)

ARCOCEA_Clinique Europe; 🇫🇷 Amiens, France

Ch Bayeux; 🇫🇷 Bayeux, France

Centre Pierre Curie; 🇫🇷 Beuvry, France

Centre François Baclesse; 🇫🇷 Caen, France

Polyclinique du Parc; 🇫🇷 Caen, France

Ch Calais; 🇫🇷 Calais, France

Ch Cherbourg; 🇫🇷 Cherbourg, France

Clinique de Flandre; 🇫🇷 Coudekerque-Branche, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Clinique des Dentellières; 🇫🇷 Valenciennes, France