Breast CancerDOLFLEXNCT07199556
Impact of a Food Supplement on Musculoskeletal Pain in Women With Breast Cancer Treated With Aromatase Inhibitors.
A study testing Food supplement in people with Breast Cancer, run by Arafarma Group, S.A. at 1 site in Spain.
Trial summary
The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks. The collagen- and chondroitin sulfate-based food supplement may help improve pain in these patients with musculoskeletal symptoms associated with hormone therapy… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Food supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2024to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with histologically confirmed hormone receptor-positive breast carcinoma, without evidence of metastatic disease (M0).
- Surgical treatment completed and any surgery-related complications resolved.
- Currently receiving hormonal therapy with aromatase inhibitors (AIs) for at least 21 days, with pain symptoms lasting less than 6 months attributable to AIs, and with a treatment plan to continue for at least an additional 180 days (6 months).
- Musculoskeletal symptoms associated with hormonal therapy that began or worsened after initiation of such therapy. New musculoskeletal pain must not be specifically due to fractures or traumatic injuries.
- "Average pain" score of at least 4, as assessed by the mBPI-sf questionnaire within 7 days prior to enrollment or baseline visit.
- ECOG performance status of 0-2.
- Patients able to provide informed consent.
Who cannot join
- Concurrent medical or arthritic conditions that may confound or interfere with the assessment of pain or efficacy, such as rheumatologic/inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) or cancer that may affect bone.
- Chemotherapy and/or radiotherapy completed within 28 days prior to enrollment or baseline visit, and/or unresolved Grade ≥2 side effects related to chemotherapy and/or radiotherapy, except for alopecia and peripheral neuropathy.
- Known allergy or hypersensitivity to Tenflex®.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of a Nutraceutical on Pain in Women With Musculoskeletal Symptoms Associated With Hormonal Therapy With Aromatase Inhibitors, in ER and/or PgR Positive Breast Cancer, After Antitumor Therapy.
The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks. The collagen- and chondroitin sulfate-based food supplement may help improve pain in these patients with musculoskeletal symptoms associated with hormone therapy in ER- and/or PR-positive breast cancer.
Read the detailed description
ER- and/or PR-positive breast cancer is treated with hormone therapy. There is a relationship between the administration of hormone therapy and the presence and/or exacerbation of joint pain in patients with breast cancer.
The administration of food supplement may result in an improvement of pain, as measured by the mBPI-sf questionnaire, in patients undergoing treatment with Aromatase Inhibitors.
- Conditions
- Breast Cancer
- Being tested
- Food supplement
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
Tenflex® is an authorized food supplement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | There is only one arm in the study. All patients will be treated with the experimental food supplement. Receives: Dietary Supplement: Food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf).
To evaluate the change in average pain intensity as measured by the modified Brief Pain Inventory-Short Form (mBPI-sf) from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. It contains 11 items and these score 0 to 10 being higher the worse pain.
Measured: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Secondary outcomes (4)
Change in quality of life Short Form 12-Item Health Survey (SF-12).
To evaluate the change of the quality of life questionnaire SF-12 from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. This survey measures eight health domains (Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH)), which are summarized into two components summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Higher scores are better health status.
Measured: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Change in quality of life 'BREAST-Q Reconstruction/Reduction/Augmentation Module'.
To evaluate the change of the quality of life questionnaire Breast-Q from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. It contains differents scales and their raw scores are converted into a scale from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Percentage of patients with ≥30% reduction in average pain.
To calculate the percentage of patients with 30% reduction in average pain from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex.
Measured: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Changes in other mBPI-sf domains.
To evaluate changes in other mBPI-sf domains (general activity, mood, walking ability, normal work, relations with others, sleep, enjoyment of life) from baseline to Weeks 4, 8, 12, and 24.
Measured: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start14 Mar 2024
- Primary completion21 Jul 2025
- Study completion10 Sep 2025
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199556
- Sponsor's protocol ID
- ARA-EXP/TEN-2023-01
- Acronym
- DOLFLEX
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of a Nutraceutical on Pain in Women With Musculoskeletal Symptoms Associated With Hormonal Therapy With Aromatase Inhibitors, in ER and/or PgR Positive Breast Cancer, After Antitumor Therapy.
- ClinicalTrials.gov ID
- NCT07199556
- Acronym / sponsor ID
- DOLFLEX / ARA-EXP/TEN-2023-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 30 Sep 2025 (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.
The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks. The collagen- and chondroitin sulfate-based food supplement may help improve pain in these patients with musculoskeletal symptoms associated with hormone therapy in ER- and/or PR-positive breast cancer.
Detailed description
ER- and/or PR-positive breast cancer is treated with hormone therapy. There is a relationship between the administration of hormone therapy and the presence and/or exacerbation of joint pain in patients with breast cancer.
The administration of food supplement may result in an improvement of pain, as measured by the mBPI-sf questionnaire, in patients undergoing treatment with Aromatase Inhibitors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Food supplementThere is only one arm in the study. All patients will be treated with the experimental food supplement. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Women with histologically confirmed hormone receptor-positive breast carcinoma, without evidence of metastatic disease (M0).
- Surgical treatment completed and any surgery-related complications resolved.
- Currently receiving hormonal therapy with aromatase inhibitors (AIs) for at least 21 days, with pain symptoms lasting less than 6 months attributable to AIs, and with a treatment plan to continue for at least an additional 180 days (6 months).
- Musculoskeletal symptoms associated with hormonal therapy that began or worsened after initiation of such therapy. New musculoskeletal pain must not be specifically due to fractures or traumatic injuries.
- "Average pain" score of at least 4, as assessed by the mBPI-sf questionnaire within 7 days prior to enrollment or baseline visit.
Key exclusion criteria (4 listed)
- Concurrent medical or arthritic conditions that may confound or interfere with the assessment of pain or efficacy, such as rheumatologic/inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica) or cancer that may affect bone.
- Chemotherapy and/or radiotherapy completed within 28 days prior to enrollment or baseline visit, and/or unresolved Grade ≥2 side effects related to chemotherapy and/or radiotherapy, except for alopecia and peripheral neuropathy.
- Known allergy or hypersensitivity to Tenflex®.
- Pregnant or breastfeeding patients.
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 |
|---|---|---|
| Food supplementTenflex® is an authorized food supplement. | Dietary supplement | Experimental |
Primary outcome
Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf).
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
To evaluate the change in average pain intensity as measured by the modified Brief Pain Inventory-Short Form (mBPI-sf) from baseline to Weeks 4, 8, 12, and 24 of treatment with Tenflex. It contains 11 items and these score 0 to 10 being higher the worse pain.
4 secondary outcomes
Change in quality of life Short Form 12-Item Health Survey (SF-12).
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Change in quality of life 'BREAST-Q Reconstruction/Reduction/Augmentation Module'.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Percentage of patients with ≥30% reduction in average pain.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Changes in other mBPI-sf domains.
Time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement in people with Breast Cancer, run by Arafarma Group, S.A. at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average pain intensity modified Brief Pain Inventory - Short Form (mBPI-sf). (time frame: Baseline visit, Week 4 visit, Week 8 visit, Week 12 visit and Week 24 visit.). 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 Oct 2025.