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

Breast Cancer Clinical Trial

— QISEIN  

Official title:

Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer - Randomized, Placebo-controlled, Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241405
• Other study ID #: 2021-A01550-41
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: September 2025

Study information

• Verified date: December 2022
• Source: Centre Francois Baclesse
• Contact: Carine SEGURA, MD
• Phone: 33231455050
• Email: c.segura[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with localized breast cancer treated with adjuvant and/or neoadjuvant chemotherapy and adjuvant radiotherapy. These treatments must be completed within 4 weeks prior to 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 (except Pembrolizumab) is allowed before and/or during the study
• 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 cancer
• Ongoing treatment with a tyrosine kinase inhibitor or other P-gp transported molecule or Pembrolizumab
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Dietary Supplement:
• QISENG
2 capsules/day for 8 weeks.
• PLACEBO
2 capsules/day for 8 weeks.

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Groupement Interrégional de Recherche Clinique et d'Innovation, NATSUCA laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue score change [min :5; max:20]	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	After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Secondary	Other dimensions of fatigue [min :12; max:48]	Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire	after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment
Secondary	The incidence of treatment-related adverse events	The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred	up to 8 weeks after the end of treatment
Secondary	Quality of life level assessed by EORTC QLQ-C30 questionnaire	EORTC QLQ-C30 quality of life questionnaire scores	4 and 8 weeks of treatment and 4 weeks after the end of treatment
Secondary	anxiety level	HADS anxiety and depression questionnaire scores	after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Secondary	Cognitive function	Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,	after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Secondary	Physical activity level	measured by the IPAQ questionnaire scores	after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
Secondary	Sleep quality	measured by CAT-sleep questionnaire scores	after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Secondary	The level of acceptability of the treatment,	measured by the total number of times the treatment was taken	over a period of 8 weeks