Colorectal CancerFIRENOXNCT06251297
Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer
A study testing Foot reflexology in people with Colorectal Cancer, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Foot reflexology
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years treated for colorectal cancer in Digestive Oncology service Rangueil hospital
- Initiation of intravenous oxaliplatin chemotherapy at 85 mg/m² on a bimonthly schedule.
- Ability to understand and answer a self-questionnaire.
- Life expectancy egal or over 12 weeks
- Signed informed consent form
Who cannot join
- Pre-existing motor and/or sensitive neuropathy.
- Reflexology treatment within the last 6 months.
- Contraindication to reflexology: venous thrombosis, trauma, wound or metastasis of the foot.
- Patient covered by a legal protection scheme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Toulouse
Toulouse, CHU de Toulouse, 31059
Nadim FARES, MD, 05 61 32 21 42 ext. 33, fares.n@chu-toulouse.fr
Caroline GREGOIRE, 05 61 32 21 88 ext. 33, gregoire.c@chu-toulouse.fr
About this study
The management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. In addition to its digestive and hematological toxicity, oxaliplatin frequently induces chronic, often limiting, sensitive peripheral neuropathy.
Only early discontinuation of oxaliplatin can limit the risk of clinically limiting neurotoxicity (grade ≥ 3).
In oncology, managing the side-effects of treatment is an essential objective of supportive care, and is open to a variety of complementary medicines, including reflexology. This technique, derived from traditional Chinese medicine, involves stimulating reflex points on the arch of the foot.
Read the detailed description
This first monocentric, prospective pilot study is designed to evaluate if the intervention is feasible in routine clinical practice for patients initiating bimonthly oxaliplatin chemotherapy for colorectal cancer. It will also provide initial estimates of the parameters needed to measure efficacy and impact on patient quality of life.
Patients will receive a reflexology session with each cycle of chemotherapy, and will be assessed during all the treatment period.
- Conditions
- Colorectal Cancer
- Being tested
- Foot reflexology
- Keywords
- oxaliplatin, reflexology
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot reflexologyOther
30 minutes reflexology session
| Study group | Role | What they receive |
|---|---|---|
| Reflexology session | Experimental | Patients included in the study and treated with oxaliplatin based regiment will receive 30-min of a standard reflexology session during each infusion for a maximum of 12 sessions over 6 months). Receives: Other: Foot reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sessions performed
at least 50% of patients included and realized at least 70% of reflexology sessions over the 6-month treatment.
Measured: 6 months
Secondary outcomes (1)
concordance of peripheral neuropathy evaluation
peripheral neuropathy evaluation between physician's assessment and programming nurse's assessment
Measured: every month until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start29 Apr 2024
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive a 30-minute reflexology session during each Oxaliplatin infusion.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadim FARES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251297
- Sponsor's protocol ID
- RC31/22/0041
- Acronym
- FIRENOX
- Status last verified
- Apr 2025
- First submitted
- 25 Jan 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06251297
- Acronym / sponsor ID
- FIRENOX / RC31/22/0041
- Conditions
- Colorectal Cancer
- Keywords
- oxaliplatin, reflexology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2024 (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 management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. In addition to its digestive and hematological toxicity, oxaliplatin frequently induces chronic, often limiting, sensitive peripheral neuropathy.
Only early discontinuation of oxaliplatin can limit the risk of clinically limiting neurotoxicity (grade ≥ 3).
In oncology, managing the side-effects of treatment is an essential objective of supportive care, and is open to a variety of complementary medicines, including reflexology. This technique, derived from traditional Chinese medicine, involves stimulating reflex points on the arch of the foot.
Detailed description
This first monocentric, prospective pilot study is designed to evaluate if the intervention is feasible in routine clinical practice for patients initiating bimonthly oxaliplatin chemotherapy for colorectal cancer. It will also provide initial estimates of the parameters needed to measure efficacy and impact on patient quality of life.
Patients will receive a reflexology session with each cycle of chemotherapy, and will be assessed during all the treatment period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive a 30-minute reflexology session during each Oxaliplatin infusion.
| Arm | Type | Receives |
|---|---|---|
| Reflexology session | Experimental | Other: Foot reflexologyPatients included in the study and treated with oxaliplatin based regiment will receive 30-min of a standard reflexology session during each infusion for a maximum of 12 sessions over 6 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18 years treated for colorectal cancer in Digestive Oncology service Rangueil hospital
- Initiation of intravenous oxaliplatin chemotherapy at 85 mg/m² on a bimonthly schedule.
- Ability to understand and answer a self-questionnaire.
- Life expectancy egal or over 12 weeks
- Signed informed consent form
Key exclusion criteria (4 listed)
- Pre-existing motor and/or sensitive neuropathy.
- Reflexology treatment within the last 6 months.
- Contraindication to reflexology: venous thrombosis, trauma, wound or metastasis of the foot.
- Patient covered by a legal protection scheme.
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 |
|---|---|---|
| Foot reflexology30 minutes reflexology session | Other | Reflexology session |
Primary outcome
number of sessions performed
Time frame: 6 months
at least 50% of patients included and realized at least 70% of reflexology sessions over the 6-month treatment.
1 secondary outcome
concordance of peripheral neuropathy evaluation
Time frame: every month until 6 months
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Nadim FARES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot reflexology in people with Colorectal Cancer, run by University Hospital, Toulouse at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 10 Apr 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 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.
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 Nadim FARES, MD (05 61 32 21 42 ext. 33, fares.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of sessions performed (time frame: 6 months). 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 10 Apr 2025.