Hormone Therapy-induced ArthralgiaPhase 4ERABLENCT07859319
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
A Phase 4 study testing Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant) and Patient Experience Questionnaire in people with Hormone Therapy-induced Arthralgia and Phytotherapy, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Adjuvant hormonotherapy is a cornerstone of treatment for localized hormone receptor-positive (HR+) breast cancer, accounting for approximately 80% of patients. The main classes used are selective estrogen receptor modulators (SERMs, including tamoxifen) and aromatase inhibitors (anastrozole, letrozole, exemestane)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Therapy-induced Arthralgia, Phytotherapy, Symptom Management
- What is being tested?
- Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant) and Patient Experience Questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2027to Mar 2028
- Phase
- Phase 4
- 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
- Common Inclusion Criteria (applicable to both cohorts):
- Age 18 years or older.
- Histologically or clinically confirmed localized breast cancer treated for at least 3 months with adjuvant hormone therapy according to standard clinical practices: selective estrogen receptor modulators (SERMs, e.g., tamoxifen alone), aromatase inhibitors (AIs, e.g., anastrozole, letrozole, or exemestane alone), or in combination with an LH-RH agonist (goserelin or leuprorelin). Concomitant targeted therapy with ribociclib or abemaciclib is permitted.
- Suffering from hormone therapy-induced arthralgia with a severity score of $\ge 4/10$ on a numerical rating scale (NRS).
- For women of childbearing potential: use of a highly effective contraception method throughout the study duration (excluding hormonal options, prioritizing mechanical methods such as a copper intrauterine device, male/female condoms, surgical methods like bilateral tubal ligation, or true abstinence).
- Specific Inclusion Criteria for the Interventional Cohort:
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- Provided signed and dated written informed consent.
- Affiliated with or a beneficiary of a social security regime.
- Specific Selection Criteria for the External Control Group:
- Availability of necessary clinical data required for the primary outcome evaluation (joint pain assessment at baseline/Day 0 and Day 21 $\pm 3$ days).
Who cannot join
- Specific Exclusion Criteria for the Interventional Cohort:
- Presence of medical conditions contraindicating the active ingredients of the dietary supplement: active gastroduodenal ulcer, biliary disorders (gallstones), uncontrolled heart failure, or edematous renal failure.
- Known allergy or hypersensitivity to any of the components of the dietary supplement (blackcurrant, meadowsweet, excipients, etc.).
- Hypersensitivity to salicylates.
- Pregnant or breastfeeding women.
- Persons deprived of liberty or under legal guardianship/protection.
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- Inability to complete the study diary during the follow-up period based on the investigator's judgment (e.g., non-French speaking/allophone, dementia).
- Impossibility to comply with the medical follow-up of the study for geographical, social, or psychological reasons.
- Concurrent participation in another clinical, drug, or cosmetic research study.
- Specific Non-Selection Criteria for the External Control Group:
- Patient objection or refusal regarding the reuse of their medical data for research purposes.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Oncology Unit, Hospices Civils de Lyon Est
Bron
Marie BEGUINOT, PU, MD, 04 72 35 58 85 ext. +33, marie.beguinot@chu-lyon.fr
Marie BEGUINOT, PU, MD
Oncology Unit, Hospices Civils de Lyon Nord
Lyon
Eva KALFALA, PU, MD, 04 26 73 26 12 ext. +33, Eva.kalfala@chu-lyon.fr
Eva KALFALA, PU, MD
Oncology Unit, Hospices Civils de Lyon Sud
Pierre-Bénite
Gilles FREYER, PU-PH, 04 78 86 43 18 ext. +33, gilles.freyer@chu-lyon.fr
Gilles FREYER, PU-PH
About this study
Adjuvant hormonotherapy is a cornerstone of treatment for localized hormone receptor-positive (HR+) breast cancer, accounting for approximately 80% of patients. The main classes used are selective estrogen receptor modulators (SERMs, including tamoxifen) and aromatase inhibitors (anastrozole, letrozole, exemestane), with or without LH-RH agonists (leuprorelin, goserelin), administered daily for 5 to 8 years.
However, these treatments are frequently associated with adverse events, predominantly musculoskeletal disorders such as arthralgia, which can significantly impair quality of life. These symptoms cause functional impact and promote premature discontinuation of treatment, thereby compromising therapeutic adherence and increasing the risk of tumor relapse.
Read more
Current management strategies for these arthralgias, whether pharmacological or non-pharmacological, show limited efficacy or insufficient levels of evidence, with the exception of certain approaches like acupuncture. In the absence of satisfactory solutions, many patients turn to alternative medicines, notably phytotherapy. However, these practices raise safety concerns (drug interactions, misuse) and rely on limited scientific evidence, especially since they are often underreported to healthcare professionals.
In this context, there is a clear need to rigorously evaluate new therapeutic approaches. The non-randomized ERABLE study aims to explore the efficacy and acceptability of a phytotherapy selected for its analgesic properties on hormone therapy-induced arthralgia in patients treated for localized breast cancer. If positive, this study will be followed by a randomized trial to confirm efficacy and achieve a level of evidence compatible with clinical guidelines.
- Conditions
- Hormone Therapy-induced Arthralgia, Phytotherapy, Symptom Management, Adjuvant Treatment, Patient Acceptability, Joint Pain
- Being tested
- Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant), Patient Experience Questionnaire
- Keywords
- Breast cancer, Adjuvant treatment, Hormone therapy-induced arthralgia, Phytotherapy, Quality of life
- Medical subject headings
- Arthralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant)Dietary supplement
Administration of an oral herbal dietary supplement combining Devil's claw (Harpagophytum procumbens), Meadowsweet (Filipendula ulmaria), and Blackcurrant (Ribes nigrum). The product is provided in capsule dosage form at a dose of 2 capsules twice daily (4 capsules per day) for a duration of 21 consecutive days, taken concomitantly with the patient's ongoing adjuvant hormone therapy to manage joint pain.
Patient Experience QuestionnaireOther
Administration of an ad hoc questionnaire utilizing Likert scales, conducted via telephone interview at Day 21. This tool evaluates the patient's feedback on three key implementation dimensions based on Proctor's framework: acceptability (overall perception, perceived satisfaction, and encountered difficulties), appropriateness (perceived relevance and suitability of the intervention), and feasibility.
| Study group | Role | What they receive |
|---|---|---|
| Herbal dietary supplement group (interventional group) | Experimental | Patients in the interventional arm receive a daily oral herbal dietary supplement combining Devil's claw (Harpagophytum procumbens), Meadowsweet (Filipendula ulmaria), and Blackcurrant (Ribes nigrum). The intervention is administered in a capsule dosage form at a dose of 2 capsules twice daily (totaling 4 capsules per day) for a duration of 21 consecutive days. This supportive care treatment is taken concomitantly with the patient's ongoing, standard adjuvant hormone therapy (tamoxifen, aromatase inhibitors, or LH-RH analogues) to evaluate its efficacy in managing hormone therapy-induced arthralgia. Receives: Dietary Supplement: Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant); Other: Patient Experience Questionnaire |
| Standard of care (External control) | No intervention | Patients in the external control group receive standard of care management for their hormone therapy-induced arthralgia, with no experimental phytotherapeutic intervention administered. Data regarding their joint pain are collected from routine clinical practice medical records, including a baseline numerical pain rating scale assessment (Day 0) and a follow-up assessment conducted by telephone at Day 21 (+ 3 days) during routine oncology follow-up. This group is matched with the interventional cohort based on clinical criteria such as age, hormone therapy type, and treatment line. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in joint pain score from baseline to day 21
Joint pain intensity is self-reported by the patient using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." The primary outcome is calculated as the change in the NRS score from baseline (Day 0) to Day 21, comparing the interventional group with the matched external control group.
Measured: Baseline (Day 0) and Day 21 (+ 3 days)
Secondary outcomes (3)
Change in analgesic medication consumption
Patient self-reported consumption of analgesic treatments (paracetamol, non-steroidal anti-inflammatory drugs, tramadol, codeine-containing paracetamol, morphine sulfate, or oxycodone) recorded prospectively via a daily tracking diary during the first week (Day 0 to Day 7) and the final week (Day 14 to Day 21) of the study period.
Measured: Daily tracking during the first week (Day 0 to Day 7) and final week (Day 14 to Day 21) of the 21-day intervention period
Incidence and severity of adverse events (Tolerance)
Assessment of adverse events and treatment safety evaluated through patient reporting in the study diary and clinical monitoring throughout the intervention period. Toxicity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v6.0).
Measured: Throughout the intervention and follow-up period, from Day 0 up to Day 28 (+ 3 days)
Patient experience assessment: acceptability, appropriateness, and feasibility
Evaluation of the patient's feedback regarding the phytotherapy dietary supplement using an ad hoc questionnaire with Likert scales based on Proctor's implementation framework. The questionnaire assesses three core dimensions: acceptability (overall perception, satisfaction, and difficulties encountered), appropriateness (perceived relevance and suitability of the intervention), and feasibility.
Measured: Day 21 (+ 3 days) via telephone interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Therapy-induced ArthralgiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, non-comparative, non-randomized, single-arm study.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- IPHYM
- Responsible party
- Sponsor
- Investigators
- Gilles FREYER, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859319
- Sponsor's protocol ID
- 69HCL26_0268
- Other IDs
- 2026-A02232-49
- Acronym
- ERABLE
- Status last verified
- Nov 2026
- First submitted
- 29 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
- ClinicalTrials.gov ID
- NCT07859319
- Acronym / sponsor ID
- ERABLE / 69HCL26_0268
- Conditions
- Hormone Therapy-induced Arthralgia, Phytotherapy, Symptom Management, Adjuvant Treatment, Patient Acceptability, Joint Pain
- Keywords
- Breast cancer, Adjuvant treatment, Hormone therapy-induced arthralgia, Phytotherapy, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- IPHYM
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Oct 2026 (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.
Adjuvant hormonotherapy is a cornerstone of treatment for localized hormone receptor-positive (HR+) breast cancer, accounting for approximately 80% of patients. The main classes used are selective estrogen receptor modulators (SERMs, including tamoxifen) and aromatase inhibitors (anastrozole, letrozole, exemestane), with or without LH-RH agonists (leuprorelin, goserelin), administered daily for 5 to 8 years.
However, these treatments are frequently associated with adverse events, predominantly musculoskeletal disorders such as arthralgia, which can significantly impair quality of life. These symptoms cause functional impact and promote premature discontinuation of treatment, thereby compromising therapeutic adherence and increasing the risk of tumor relapse.
Current management strategies for these arthralgias, whether pharmacological or non-pharmacological, show limited efficacy or insufficient levels of evidence, with the exception of certain approaches like acupuncture. In the absence of satisfactory solutions, many patients turn to alternative medicines, notably phytotherapy. However, these practices raise safety concerns (drug interactions, misuse) and rely on limited scientific evidence, especially since they are often underreported to healthcare professionals.
In this context, there is a clear need to rigorously evaluate new therapeutic approaches. The non-randomized ERABLE study aims to explore the efficacy and acceptability of a phytotherapy selected for its analgesic properties on hormone therapy-induced arthralgia in patients treated for localized breast cancer. If positive, this study will be followed by a randomized trial to confirm efficacy and achieve a level of evidence compatible with clinical guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, non-comparative, non-randomized, single-arm study.
| Arm | Type | Receives |
|---|---|---|
| Herbal dietary supplement group (interventional group) | Experimental | Dietary Supplement: Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant), Other: Patient Experience QuestionnairePatients in the interventional arm receive a daily oral herbal dietary supplement combining Devil's claw (Harpagophytum procumbens), Meadowsweet (Filipendula ulmaria), and Blackcurrant (Ribes nigrum). The intervention is administered in a capsule dosage form at a dose of 2 capsules twice daily (totaling 4 capsules per day) for a duration of 21 consecutive days. This supportive care treatment is taken concomitantly with the patient's ongoing, standard adjuvant hormone therapy (tamoxifen, aromatase inhibitors, or LH-RH analogues) to evaluate its efficacy in managing hormone therapy-induced arthralgia. |
| Standard of care (External control) | No intervention | –Patients in the external control group receive standard of care management for their hormone therapy-induced arthralgia, with no experimental phytotherapeutic intervention administered. Data regarding their joint pain are collected from routine clinical practice medical records, including a baseline numerical pain rating scale assessment (Day 0) and a follow-up assessment conducted by telephone at Day 21 (+ 3 days) during routine oncology follow-up. This group is matched with the interventional cohort based on clinical criteria such as age, hormone therapy type, and treatment line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Common Inclusion Criteria (applicable to both cohorts):
- Age 18 years or older.
- Histologically or clinically confirmed localized breast cancer treated for at least 3 months with adjuvant hormone therapy according to standard clinical practices: selective estrogen receptor modulators (SERMs, e.g., tamoxifen alone), aromatase inhibitors (AIs, e.g., anastrozole, letrozole, or exemestane alone), or in combination with an LH-RH agonist (goserelin or leuprorelin). Concomitant targeted therapy with ribociclib or abemaciclib is permitted.
- Suffering from hormone therapy-induced arthralgia with a severity score of $\ge 4/10$ on a numerical rating scale (NRS).
- For women of childbearing potential: use of a highly effective contraception method throughout the study duration (excluding hormonal options, prioritizing mechanical methods such as a copper intrauterine device, male/female condoms, surgical methods like bilateral tubal ligation, or true abstinence).
Key exclusion criteria (11 listed)
- Specific Exclusion Criteria for the Interventional Cohort:
- Presence of medical conditions contraindicating the active ingredients of the dietary supplement: active gastroduodenal ulcer, biliary disorders (gallstones), uncontrolled heart failure, or edematous renal failure.
- Known allergy or hypersensitivity to any of the components of the dietary supplement (blackcurrant, meadowsweet, excipients, etc.).
- Hypersensitivity to salicylates.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant)Administration of an oral herbal dietary supplement combining Devil's claw (Harpagophytum procumbens), Meadowsweet (Filipendula ulmaria), and Blackcurrant (Ribes nigrum). The product is provided in capsule dosage form at a dose of 2 capsules twice daily (4 capsules per day) for a duration of 21 consecutive days, taken concomitantly with the patient's ongoing adjuvant hormone therapy to manage joint pain. | Dietary supplement | Herbal dietary supplement group (interventional group) |
| Patient Experience QuestionnaireAdministration of an ad hoc questionnaire utilizing Likert scales, conducted via telephone interview at Day 21. This tool evaluates the patient's feedback on three key implementation dimensions based on Proctor's framework: acceptability (overall perception, perceived satisfaction, and encountered difficulties), appropriateness (perceived relevance and suitability of the intervention), and feasibility. | Other | Herbal dietary supplement group (interventional group) |
Primary outcome
Change in joint pain score from baseline to day 21
Time frame: Baseline (Day 0) and Day 21 (+ 3 days)
Joint pain intensity is self-reported by the patient using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." The primary outcome is calculated as the change in the NRS score from baseline (Day 0) to Day 21, comparing the interventional group with the matched external control group.
3 secondary outcomes
Change in analgesic medication consumption
Time frame: Daily tracking during the first week (Day 0 to Day 7) and final week (Day 14 to Day 21) of the 21-day intervention period
Incidence and severity of adverse events (Tolerance)
Time frame: Throughout the intervention and follow-up period, from Day 0 up to Day 28 (+ 3 days)
Patient experience assessment: acceptability, appropriateness, and feasibility
Time frame: Day 21 (+ 3 days) via telephone interview
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 3 Nov 2026.
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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.
Gilles FREYER, Pr principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phytotherapy Dietary Supplement (Harpagophytum, Meadowsweet, and Blackcurrant) and Patient Experience Questionnaire in people with Hormone Therapy-induced Arthralgia and Phytotherapy, run by Hospices Civils de Lyon at 3 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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Gilles FREYER, Pr (04 78 86 43 18 ext. +33, gilles.freyer@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in joint pain score from baseline to day 21 (time frame: Baseline (Day 0) and Day 21 (+ 3 days)). 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 3 Nov 2026.