Menu
Recruiting NCT05241405

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

No phase Interventional Breast Cancer Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QISENG, PLACEBO.
Who it may be relevant to
Registry conditions: Breast Cancer, Fatigue. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

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

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 10 centers
  • ARCOCEA_Clinique Europe — Amiens
  • Ch Bayeux — Bayeux
  • Centre Pierre Curie — Beuvry
  • Centre François Baclesse — Caen
  • Polyclinique du Parc — Caen
  • Ch Calais — Calais
  • Ch Cherbourg — Cherbourg
  • Clinique de Flandre — Coudekerque-Branche
  • … and 2 more centers

Identifiers

NCT: NCT05241405 · 2021-A01550-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗