Lung Cancer and Cancer of Digestive SystemREFYO-RNCT03508180
Benefit Evaluation of Foot Reflexology in Oncology
A study testing INTERVIONNAL in people with Lung Cancer and Cancer of Digestive System, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer and Cancer of Digestive System
- What is being tested?
- INTERVIONNAL
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2018to 8 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy
- Good performance status of (ECOG 0-2)
- More than 18 years old
- Ability to complete the questionnaires (comprehension oral and written French language) and to carry out the required exercises.
- Patient affiliated to Social Security or equivalent
- Informed consent signed
Who cannot join
- Phlebitis
- Cellar syndrome
- Weight loss> 5% in 3 months
- Uncontrolled pain
- Patients under morphine and derivatives
- Brain metastases
- Patient benefiting from foot reflexology outside the study
- Patient under guardianship or curatorship or deprived of his rights
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy
Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.
- Being tested
- INTERVIONNAL, CONTROL
- Keywords
- Supportive care, cancer, foot reflexology, nausea, vomiting
- Medical subject headings
- Lung Neoplasms, Digestive System Neoplasms, Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERVIONNALBehavioural
Foot reflexology session (30 minutes) each course of chemotherapy (total 4 courses) during the 4 hours following the first 2 hours of injection + auto-massage done by the patient between each course.
During a session focused on the treatment of nausea / vomiting, the reflexologist will stimulate the reflex zones related to the digestive system in order to calm and stimulate all areas for deep relaxation of the patient.
CONTROLOther
None intervention.
| Study group | Role | What they receive |
|---|---|---|
| foot reflexology | Experimental | patients WITH foot reflexology session during chemotherapy treatments Receives: Behavioral: INTERVIONNAL |
| platinum-based treatment | Placebo comparator | Patients WITHOUT ANY foot reflexology session during chemotherapy treatments Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of nausea and vomiting
The relative change in VAS* associated with nausea and vomiting will be evaluated between T1 (measured at least 2 hours after the start of chemotherapy injection) and T2 (measured at least 6 hours after the start of injection of the drug chemotherapy).
*VAS : from 0 to 10 ; 0 is no nausea or vomiting and 10 is insufferable nausea or vomiting
Measured: 6 hours
Secondary outcomes (4)
Nausea and vomiting between each chemotherapy
Between each chemotherapy the patient notes daily whether or not he has had nausea on a notebook.
Measured: Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63.
Quality of life
Relative variation of the EORTC QLQC 30* (European Organisation for Research and Treatment of Cancer) between the inclusion visit (V2) and the end-of-study visit (V6).
*EORTC QLQ C30 : All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: Between day 0 and day 78
Anxiety
Relative variation of the HADS* (Hospital and Anxiety Depression Scale) anxiety score between the inclusion visit (V2) and the end-of-study visit (V6).
*HADS : 0 to 21, the highest scores corresponding to the presence of a more severe symptomatology
Measured: Between day 0 and day 78
Body image
Evaluation of the body image to the end-of-study visit by the Body Image Questionnaire* (BIC), which measures the body image at a given moment t. The analysis will take into account the self-esteem assessed upon the inclusion visit on the Rosenberg scale** (V2).
*BIC : The total score is between 19 and 95.
**Rosenberg Scale : The total score ranges from 10 to 40. A score below 31 is considered low self-esteem
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start14 Jun 2018
- Primary completion3 Feb 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer and Cancer of Digestive SystemStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Jean SOUQUET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508180
- Sponsor's protocol ID
- 69HCL17_0676
- Acronym
- REFYO-R
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murat-Ringot A, Souquet PJ, Chauvenet M, Rentler C, Subtil F, Schott AM, Preau M, Piriou V. The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17232. doi: 10.2196/17232.
PubMed 32449505Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.
PubMed 34738909
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy
- ClinicalTrials.gov ID
- NCT03508180
- Acronym / sponsor ID
- REFYO-R / 69HCL17_0676
- Keywords
- Supportive care, cancer, foot reflexology, nausea, vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 25 Apr 2018 (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.
Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| foot reflexology | Experimental | Behavioral: INTERVIONNALpatients WITH foot reflexology session during chemotherapy treatments |
| platinum-based treatment | Placebo comparator | Other: CONTROLPatients WITHOUT ANY foot reflexology session during chemotherapy treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy
- Good performance status of (ECOG 0-2)
- More than 18 years old
- Ability to complete the questionnaires (comprehension oral and written French language) and to carry out the required exercises.
- Patient affiliated to Social Security or equivalent
Key exclusion criteria (8 listed)
- Phlebitis
- Cellar syndrome
- Weight loss> 5% in 3 months
- Uncontrolled pain
- Patients under morphine and derivatives
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 |
|---|---|---|
| INTERVIONNALFoot reflexology session (30 minutes) each course of chemotherapy (total 4 courses) during the 4 hours following the first 2 hours of injection + auto-massage done by the patient between each course. During a session focused on the treatment of nausea / vomiting, the reflexologist will stimulate the reflex zones related to the digestive system in order to calm and stimulate all areas for deep relaxation of the patient. | Behavioural | foot reflexology |
| CONTROLNone intervention. | Other | platinum-based treatment |
Primary outcome
Evaluation of nausea and vomiting
Time frame: 6 hours
The relative change in VAS* associated with nausea and vomiting will be evaluated between T1 (measured at least 2 hours after the start of chemotherapy injection) and T2 (measured at least 6 hours after the start of injection of the drug chemotherapy). *VAS : from 0 to 10 ; 0 is no nausea or vomiting and 10 is insufferable nausea or vomiting
4 secondary outcomes
Nausea and vomiting between each chemotherapy
Time frame: Day 0, between day 14 and day 21, between day 28 and day 42, between day 42 and day 63.
Quality of life
Time frame: Between day 0 and day 78
Anxiety
Time frame: Between day 0 and day 78
Body image
Time frame: Day 0
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 19 Dec 2025.
- Results publication: PubMed 32449505Murat-Ringot A, Souquet PJ, Chauvenet M, Rentler C, Subtil F, Schott AM, Preau M, Piriou V. The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17232. doi: 10.2196/17232.
- Results publication: PubMed 34738909Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.
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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.
Pierre-Jean SOUQUET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTERVIONNAL in people with Lung Cancer and Cancer of Digestive System, run by Hospices Civils de Lyon 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 6 inclusion and 8 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 19 Dec 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. Some participants in this study may receive a placebo. 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?
Evaluation of nausea and vomiting (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508180, which also lists 2 linked publications.
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 19 Dec 2025.