RecruitingNAINTERVENTIONAL

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

This research trial aims to find out if a supplement called Qiseng can help ease the persistent tiredness many women feel after being treated for breast or gynaecological cancer. Qiseng is a combination of American ginseng and vitamin C, sourced from Camu Camu berries. We are inviting women who have recently finished their cancer treatment and are experiencing ongoing tiredness to take part. Half the participants will receive Qiseng, and the other half will receive a dummy pill (placebo). Neither the patients nor their doctors will know who is getting which. The study will last for 8 weeks and will help us understand if Qiseng is effective and safe in reducing cancer-related fatigue.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Francois Baclesse

Enrolment target

354

Start

27 Sep 2022

Estimated completion

01 Sep 2027

Breast Cancer Fatigue

What is this study about?

Many women experience lasting tiredness, often called fatigue, after going through treatment for breast or gynaecological cancer. This tiredness can really affect daily life and how well you feel. This study is designed to investigate a potential new way to help manage this common and challenging side effect.

The trial is looking at a specific supplement called Qiseng, which combines American ginseng extract with vitamin C from Camu Camu berries. Ginseng has often been thought to help with energy, and vitamin C is important for overall health. By studying this combination, researchers hope to see if it can genuinely make a difference in reducing cancer-related fatigue.

This is a 'randomised' study, which means participants are put into groups by chance, like flipping a coin. One group will receive Qiseng, and the other will get a 'placebo' – a dummy pill that looks just like Qiseng but contains no active ingredients. This method helps scientists fairly compare the effects of Qiseng against receiving no active treatment, giving us a clearer picture of whether it works. The study will also carefully check for any side effects.

Key takeaways

Tests Qiseng, a supplement, for cancer-related fatigue.
For women treated for breast or gynaecological cancer.
Compares Qiseng to a dummy pill (placebo) for 8 weeks.
Aims to see if Qiseng is safe and reduces tiredness.
Participation includes taking capsules and regular check-ups.
You can stop participating at any time.

Who may be eligible?

This study is looking for women who have been treated for breast or gynaecological cancer. Your cancer treatment, such as chemotherapy or radiotherapy, must have finished within the last six months. It’s important that you’re feeling a stable, ongoing tiredness that you’d rate as at least 4 out of 10, and this tiredness has been present for at least a month.

You must be 18 years or older, and if you can still have children, you need to be using effective contraception. You can be on other maintenance cancer treatments like hormone therapy, but certain newer drugs (like pembrolizumab, abemaciclib, or PARP inhibitors) mean you can't join this study.

There are also some reasons why you wouldn't be able to join. For example, if your tiredness is caused by something else that's already known, like severe anaemia, or if you're currently having chemotherapy. You also can't take part if your cancer has spread (metastatic) or if you're taking certain other medications or ginseng products already. We also need to make sure you're not pregnant or breastfeeding, and that you haven't been taking extra vitamin C supplements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman treated for breast or gynaecological cancer.
My main cancer treatment (chemo or radio) finished within the last 6 months.
I have been feeling ongoing tiredness (fatigue) for at least a month, rating it 4 or more out of 10.
I am 18 years old or older.
I am not currently pregnant or breastfeeding.
I am not currently taking other strong drugs for tiredness or specific cancer medicines (like pembrolizumab).
I do not already take ginseng products or extra vitamin C supplements.

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for 8 weeks. You'll be randomly assigned to either receive the Qiseng supplement or a dummy pill (placebo).

Throughout the 8 weeks, you'll be asked to take a specific number of capsules each day. You will have regular check-ups with the study team, likely at a clinic, where they will ask you about your fatigue levels, any side effects you might be experiencing, and your general well-being. These checks will probably involve filling out questionnaires and possibly some simple tests.

There will also be a follow-up after the 8-week treatment period to see how you are doing. The exact number of visits and tests will be explained to you in detail by the study team, but generally, you can expect a few in-person appointments spread over the 8 weeks, plus the follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might find that Qiseng helps reduce your fatigue, which could improve your quality of life. Even if you receive the placebo, your regular check-ups and close monitoring by medical professionals might be beneficial. However, there's also a chance that Qiseng won't help your fatigue, or you might experience side effects, just as with any supplement or medicine. The study team will carefully monitor you for any problems. It's very important to remember that joining this study is completely voluntary, and you are free to leave at any time, for any reason, without it affecting your usual medical care.

Locations (10)

ARCOCEA_Clinique Europe
Verified postcode
Amiens, France· Not yet recruiting
Ch Bayeux
Verified postcode
Bayeux, France· Not yet recruiting
Centre Pierre Curie
Verified postcode
Beuvry, France· Not yet recruiting
Centre François Baclesse
Verified postcode
Caen, France· Recruiting
Polyclinique du Parc
Verified postcode
Caen, France· Not yet recruiting
Ch Calais
Verified postcode
Calais, France· Recruiting
Ch Cherbourg
Verified postcode
Cherbourg, France· Not yet recruiting
Clinique de Flandre
Verified postcode
Coudekerque-Branche, France· Recruiting
Centre Henri Becquerel
Verified postcode
Rouen, France· Recruiting
Clinique des Dentellières
Verified postcode
Valenciennes, France· Recruiting

Common questions

What is Qiseng?

Qiseng is a supplement being tested in this study. It contains extracts from American ginseng and vitamin C from Camu Camu berries.

Will I know if I'm taking Qiseng or the dummy pill?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're taking Qiseng or the placebo. This helps make the study results fair.

How long will I take the study treatment?

If you join the study, you will take the assigned capsules every day for 8 weeks.

What kind of cancer treatment must I have had?

You must have had curative chemotherapy or radiotherapy for breast or gynaecological cancer, and this treatment must have finished within the last six months.

What if I feel worse during the study?

Your well-being will be closely monitored. You should tell the study team about any changes in how you feel, and you can leave the study at any time.

How to find out more

Carine SEGURA, MD

c.segura@baclesse.unicancer.fr +33231455050 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.