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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05241405




Registration number
NCT05241405
Ethics application status
Date submitted
3/02/2022
Date registered
15/02/2022

Titles & IDs
Public title
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
Scientific 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
Secondary ID [1] 0 0
2021-A01550-41
Universal Trial Number (UTN)
Trial acronym
QISEIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Fatigue 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - QISENG
Treatment: Other - PLACEBO

Experimental: 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 comparator: Placebo - neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract


Treatment: Other: QISENG
2 capsules/day for 8 weeks.

Treatment: Other: PLACEBO
2 capsules/day for 8 weeks.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fatigue score change [min :5; max:20]
Timepoint [1] 0 0
After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Secondary outcome [1] 0 0
Other dimensions of fatigue [min :12; max:48]
Timepoint [1] 0 0
after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment
Secondary outcome [2] 0 0
The incidence of treatment-related adverse events
Timepoint [2] 0 0
up to 8 weeks after the end of treatment
Secondary outcome [3] 0 0
Quality of life level assessed by EORTC QLQ-C30 questionnaire
Timepoint [3] 0 0
4 and 8 weeks of treatment and 4 weeks after the end of treatment
Secondary outcome [4] 0 0
anxiety level
Timepoint [4] 0 0
after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Secondary outcome [5] 0 0
Cognitive function
Timepoint [5] 0 0
after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Secondary outcome [6] 0 0
Physical activity level
Timepoint [6] 0 0
after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
Secondary outcome [7] 0 0
Sleep quality
Timepoint [7] 0 0
after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Secondary outcome [8] 0 0
The level of acceptability of the treatment,
Timepoint [8] 0 0
over a period of 8 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
354
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Amiens
Country [2] 0 0
France
State/province [2] 0 0
Bayeux
Country [3] 0 0
France
State/province [3] 0 0
Beuvry
Country [4] 0 0
France
State/province [4] 0 0
Caen
Country [5] 0 0
France
State/province [5] 0 0
Calais
Country [6] 0 0
France
State/province [6] 0 0
Cherbourg
Country [7] 0 0
France
State/province [7] 0 0
Coudekerque-Branche
Country [8] 0 0
France
State/province [8] 0 0
Rouen
Country [9] 0 0
France
State/province [9] 0 0
Valenciennes

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Francois Baclesse
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NATSUCA laboratory
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Groupement Interrégional de Recherche Clinique et d'Innovation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carine SEGURA, MD
Address 0 0
Country 0 0
Phone 0 0
+33231455050
Fax 0 0
Email 0 0
c.segura@baclesse.unicancer.fr
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05241405