Lung CancerNCT04718610
Heart Rate Variability, Vagus Nerve and Cancer
A study testing Osteopathic intervention, CRP assessment and QLQ-C30 questionnaire in people with Lung Cancer and Colorectal Cancer, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial summary
In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Colorectal Cancer, Multiple Myeloma
- What is being tested?
- Osteopathic intervention, CRP assessment and QLQ-C30 questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2021to 19 Sep 2021
- 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 lung cancer or colorectal cancer or Non Hodgkin Lymphoma or Multiple Myeloma (Stade I à IV)
- No previous treatment
- HRV < 70 ms
- No osteopathic contraindication
Who cannot join
- Vagotomy
- Heart arrhythmia
- Cancer recurrence
- Consumption of coffee or tabac within 2 hours prior osteopathic treatment
- Consumption of alcohol within 24 hours prior osteopathic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients
In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy.
Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations.
This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.
- Conditions
- Lung Cancer, Colorectal Cancer, Multiple Myeloma, Non Hodgkin Lymphoma
- Being tested
- Osteopathic intervention, CRP assessment, QLQ-C30 questionnaire
- Keywords
- Cancer, Vagus nerve stimulation, Heart rate variability, Osteopathy
- Medical subject headings
- Lung Neoplasms, Colorectal Neoplasms, Multiple Myeloma, Lymphoma, Non-Hodgkin, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic interventionOther
Nerve vagus stimulation
CRP assessmentBiological
Blood CRP will be assessed during trial
QLQ-C30 questionnaireBehavioural
Completion of QLQ-C30
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients will receive only caner treatment. No osteopathic treatment. Receives: Biological: CRP assessment; Behavioral: QLQ-C30 questionnaire |
| Osteopathic intervention | Experimental | Patients will receive cancer treatment associated with osteopathic intervention Receives: Other: Osteopathic intervention; Biological: CRP assessment; Behavioral: QLQ-C30 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment
To assess the effect of vagus nerve osteopathic stimulations on Heart Rate Variability
Measured: up to 84 days
Secondary outcomes (2)
Serum concentration of C-Reactive Protein
To assess the effect of vagus nerve osteopathic stimulations on systemic inflammatory
Measured: up to 84 days
Time to definitive improvement in global health status / QoL
To assess the effect of vagus nerve osteopathic stimulations on health related quality of life
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start12 Jan 2021
- Primary completion19 Sep 2021
- Study completion19 Sep 2021
Why it stopped: Heart rate measurement error
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For each cancer type, 30 patients will be included. These patients will be randomized into two groups.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Formation en Ostéopathie du Grand Avignon
- Responsible party
- Sponsor
- Investigators
- Borhane SLAMA, MD, Principal investigator, Centre Hospitalier Henri Duffaut - Avignon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718610
- Sponsor's protocol ID
- OSTEOCAN
- Status last verified
- May 2024
- First submitted
- 14 Jan 2021
- Last updated
- 13 May 2024
- 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 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients
- ClinicalTrials.gov ID
- NCT04718610
- Acronym / sponsor ID
- OSTEOCAN
- Conditions
- Lung Cancer, Colorectal Cancer, Multiple Myeloma, Non Hodgkin Lymphoma
- Keywords
- Cancer, Vagus nerve stimulation, Heart rate variability, Osteopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Heart rate measurement error
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Collaborators
- Institut de Formation en Ostéopathie du Grand Avignon
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 22 Jan 2021 (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.
In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy.
Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations.
This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For each cancer type, 30 patients will be included. These patients will be randomized into two groups.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Biological: CRP assessment, Behavioral: QLQ-C30 questionnairePatients will receive only caner treatment. No osteopathic treatment. |
| Osteopathic intervention | Experimental | Other: Osteopathic intervention, Biological: CRP assessment, Behavioral: QLQ-C30 questionnairePatients will receive cancer treatment associated with osteopathic intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with lung cancer or colorectal cancer or Non Hodgkin Lymphoma or Multiple Myeloma (Stade I à IV)
- No previous treatment
- HRV < 70 ms
- No osteopathic contraindication
Key exclusion criteria (5 listed)
- Vagotomy
- Heart arrhythmia
- Cancer recurrence
- Consumption of coffee or tabac within 2 hours prior osteopathic treatment
- Consumption of alcohol within 24 hours prior osteopathic treatment
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 |
|---|---|---|
| Osteopathic interventionNerve vagus stimulation | Other | Osteopathic intervention |
| CRP assessmentBlood CRP will be assessed during trial | Biological | Control, Osteopathic intervention |
| QLQ-C30 questionnaireCompletion of QLQ-C30 | Behavioural | Control, Osteopathic intervention |
Primary outcome
Change of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment
Time frame: up to 84 days
To assess the effect of vagus nerve osteopathic stimulations on Heart Rate Variability
2 secondary outcomes
Serum concentration of C-Reactive Protein
Time frame: up to 84 days
Time to definitive improvement in global health status / QoL
Time frame: up to 84 days
Results and safety
The study was stopped early (reason given: Heart rate measurement error). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- 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. This study is not recruiting at the moment.
Borhane SLAMA, MD principal investigator
Centre Hospitalier Henri Duffaut - Avignon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic intervention, CRP assessment and QLQ-C30 questionnaire in people with Lung Cancer and Colorectal Cancer, run by Centre Hospitalier Henri Duffaut - Avignon 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 May 2024. 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?
The study was stopped early (reason given: Heart rate measurement error). Results are not available in the source record.
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 of Heart Rate Variability measured by SDNN (Standard Deviation of all NN intervals) from baseline to the end of osteopathic treatment (time frame: up to 84 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 13 May 2024.