Breast CancerQISEINNCT05241405
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast or Gynecological Cancer
A study testing QISENG in people with Breast Cancer and Fatigue, run by Centre Francois Baclesse at 10 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- QISENG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 10 sitesFrance
- Study dates
- 27 Sep 2022to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra LECONTE contact
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
ARCOCEA_Clinique Europe
Amiens
Michel GOSY, MD
- Not yet recruiting
Ch Bayeux
Bayeux
Pierre-Emmanuel BRACHET, MD
- Not yet recruiting
Centre Pierre Curie
Beuvry
Jean-Briac PREVOST, MD
- Recruiting
Centre François Baclesse
Caen
Carine SEGURA, MD, c.segura@baclesse.unicancer.fr
- Not yet recruiting
Polyclinique du Parc
Caen
Emmanuel SEVIN, MD
- Recruiting
Ch Calais
Calais
Fatima MENIAI, MD
- Not yet recruiting
Ch Cherbourg
Cherbourg
Laure KALUZINSKI, MD
- Recruiting
Clinique de Flandre
Coudekerque-Branche
Jean-Baptiste AISENFARB, MD
- Recruiting
Centre Henri Becquerel
Rouen
Olivier RIGAL, MD
- Recruiting
Clinique des Dentellières
Valenciennes
JESSICA GROSJEAN, MD
About this study
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
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
- Conditions
- Breast Cancer, Fatigue
- Being tested
- QISENG, PLACEBO
- Keywords
- Qiseng, food supplement
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QISENGDietary supplement
2 capsules/day for 8 weeks.
PLACEBODietary supplement
2 capsules/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Qiseng | Experimental | 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 Receives: Dietary Supplement: QISENG |
| Placebo | Placebo comparator | neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Secondary outcomes (8)
Other dimensions of fatigue [min :12; max:48]
Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire
Measured: 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
The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred
Measured: up to 8 weeks after the end of treatment
Quality of life level assessed by EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 quality of life questionnaire scores
Measured: 4 and 8 weeks of treatment and 4 weeks after the end of treatment
anxiety level
HADS anxiety and depression questionnaire scores
Measured: after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Cognitive function
Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,
Measured: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Physical activity level
measured by the IPAQ questionnaire scores
Measured: after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
Sleep quality
measured by CAT-sleep questionnaire scores
Measured: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
The level of acceptability of the treatment,
measured by the total number of times the treatment was taken
Measured: over a period of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start27 Sep 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- NATSUCA laboratory, Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241405
- Sponsor's protocol ID
- 2021-A01550-41
- Acronym
- QISEIN
- Status last verified
- Sep 2024
- First submitted
- 3 Feb 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05241405
- Acronym / sponsor ID
- QISEIN / 2021-A01550-41
- Conditions
- Breast Cancer, Fatigue
- Keywords
- Qiseng, food supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- NATSUCA laboratory, Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qiseng | Experimental | Dietary Supplement: QISENG200 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 comparator | Dietary Supplement: PLACEBOneutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QISENG2 capsules/day for 8 weeks. | Dietary supplement | Qiseng |
| PLACEBO2 capsules/day for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Fatigue score change [min :5; max:20]
Time frame: 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
8 secondary outcomes
Other dimensions of fatigue [min :12; max:48]
Time frame: 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
Time frame: up to 8 weeks after the end of treatment
Quality of life level assessed by EORTC QLQ-C30 questionnaire
Time frame: 4 and 8 weeks of treatment and 4 weeks after the end of treatment
anxiety level
Time frame: after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Cognitive function
Time frame: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Physical activity level
Time frame: after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
Sleep quality
Time frame: after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
The level of acceptability of the treatment,
Time frame: over a period of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra LECONTE contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QISENG in people with Breast Cancer and Fatigue, run by Centre Francois Baclesse at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carine SEGURA, MD (+33231455050, c.segura@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue score change [min :5; max:20] (time frame: After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.