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

Primary Purpose

Breast Cancer, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QISENG
PLACEBO
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Qiseng, food supplement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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, 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
  • 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

Sites / Locations

  • ARCOCEA_Clinique Europe
  • Ch Bayeux
  • Centre Pierre Curie
  • Centre François BaclesseRecruiting
  • Polyclinique du Parc
  • Ch Calais
  • Ch Cherbourg
  • Clinique de FlandreRecruiting
  • Centre Henri BecquerelRecruiting
  • Clinique des DentellièresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Qiseng

Placebo

Arm Description

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

neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Other dimensions of fatigue [min :12; max:48]
Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire
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
Quality of life level assessed by EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 quality of life questionnaire scores
anxiety level
HADS anxiety and depression questionnaire scores
Cognitive function
Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,
Physical activity level
measured by the IPAQ questionnaire scores
Sleep quality
measured by CAT-sleep questionnaire scores
The level of acceptability of the treatment,
measured by the total number of times the treatment was taken

Full Information

First Posted
February 3, 2022
Last Updated
December 12, 2022
Sponsor
Centre Francois Baclesse
Collaborators
NATSUCA laboratory, Groupement Interrégional de Recherche Clinique et d'Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT05241405
Brief Title
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
NATSUCA laboratory, Groupement Interrégional de Recherche Clinique et d'Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue
Keywords
Qiseng, food supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qiseng
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
neutral microgranules of Qiseng® excipients without P. quinquefolius or Camu Camu extract
Intervention Type
Dietary Supplement
Intervention Name(s)
QISENG
Intervention Description
2 capsules/day for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
2 capsules/day for 8 weeks.
Primary Outcome Measure Information:
Title
Fatigue score change [min :5; max:20]
Description
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
Time Frame
After 1 week and 4 weeks after the end of treatment (so 8 weeks of treatment)
Secondary Outcome Measure Information:
Title
Other dimensions of fatigue [min :12; max:48]
Description
Score of emotional fatigue, cognitive fatigue, global score, according to the EORTC QLQ-FA12 self-questionnaire
Time Frame
after 4 weeks of treatment, after 8 weeks of treatment and 4 weeks after the end of treatment
Title
The incidence of treatment-related adverse events
Description
The incidence of treatment-related adverse events and the number of patients in whom at least one treatment-related adverse event occurred
Time Frame
up to 8 weeks after the end of treatment
Title
Quality of life level assessed by EORTC QLQ-C30 questionnaire
Description
EORTC QLQ-C30 quality of life questionnaire scores
Time Frame
4 and 8 weeks of treatment and 4 weeks after the end of treatment
Title
anxiety level
Description
HADS anxiety and depression questionnaire scores
Time Frame
after 4 and 8 weeks of treatment, and 4 weeks after the end of treatment
Title
Cognitive function
Description
Cognitive function dimensions, according to the FACT-Cog self-assessment questionnaire,
Time Frame
after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Title
Physical activity level
Description
measured by the IPAQ questionnaire scores
Time Frame
after 4 and 8 weeks of treatment, and again 4 weeks after the end of treatment
Title
Sleep quality
Description
measured by CAT-sleep questionnaire scores
Time Frame
after 4 and 8 weeks of treatment and 4 weeks after the end of treatment
Title
The level of acceptability of the treatment,
Description
measured by the total number of times the treatment was taken
Time Frame
over a period of 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine SEGURA, MD
Phone
33231455050
Email
c.segura@baclesse.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra LECONTE
Email
a.leconte@baclesse.unicancer.fr
Facility Information:
Facility Name
ARCOCEA_Clinique Europe
City
Amiens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel GOSY, MD
Facility Name
Ch Bayeux
City
Bayeux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel BRACHET, MD
Facility Name
Centre Pierre Curie
City
Beuvry
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Briac BRIAC, MD
Facility Name
Centre François Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine SEGURA, MD
Email
c.segura@baclesse.unicancer.fr
Facility Name
Polyclinique du Parc
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel SEVIN, MD
Facility Name
Ch Calais
City
Calais
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Briac Prevost, MD
Facility Name
Ch Cherbourg
City
Cherbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure KALUZINSKI, MD
Facility Name
Clinique de Flandre
City
Coudekerque-Branche
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe WAGNER, MD
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier RIGAL, MD
Facility Name
Clinique des Dentellières
City
Valenciennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JESSICA GROSJEAN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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