CancerHYPOSTEONCT07860476
Impact of Therapeutic Osteopathy-hypnosis on Cancer Patients.
A study testing Osteopathy and Hypnosis in people with Cancer, run by Institut Rafael at 1 site in France.
Trial summary
Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Osteopathy and Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2026to Sep 2028
- 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
- 18 years,
- Patient diagnosed with cancer (currently undergoing treatment or having completed oncological treatment),
- Experiencing chronic pain (≥ 3 months),
- Presenting a strong emotional component to the pain: K10 score between 20 and 29,
- Patient able to attend all visits and follow study procedures,
- Patient who has provided consent.
Who cannot join
- Patients with no emotional distress or with severe distress
- Sensory (auditory, visual) or cognitive deficits likely to hinder the conduct of hypnosis sessions
- Patient who has undergone hypnotherapy sessions within the last 3 months
- Patient unable to provide consent
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
Institut Rafael
Levallois-Perret, Île-de-France Region, 92300
Nathaniel SCHER, M.D., + 33 (0)1 47 58 05 96, n.scher@rt-hartmann.fr
Daniele GRAZZIOTIN, PharmD, PhD, + 33 (0)1 84 00 70 07, daniele.grazz@institut-rafael.fr
About this study
Official title: Functional and Psychological Evaluation of Combined Osteopathy and Therapeutic Hypnosis in Cancer Patients Living With Chronic Pain: a Randomized Study Comparing Osteopathy and Hypnosis With Osteopathy Alone.
Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.
Combining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component.
Read the detailed description
While increasingly effective, cancer treatments are often accompanied by severe side effects, including chronic pain, fatigue, and reduced quality of life. Pain has often a strong emotional component, influenced by anxiety, stress, or the psychological distress inherent in the treatment journey.
Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.
However, pain with a strong emotional component may require a more holistic approach; osteopathy offers gradual benefits that can be optimized by combining it with other complementary therapies, such as hypnosis.
As a complementary therapy, hypnosis is increasingly used for pain and stress management in oncology. It works by modulating pain perception and reducing anxiety, thereby helping patients cope better with their symptoms.
Combining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component. This combined approach could represent a significant step forward in improving the well-being of oncology patients by offering care that is better suited to the multidimensional nature of pain.
This research combining osteopathy and hypnosis could help improve symptoms and quality of life of cancer patients, particularly those suffering from chronic pain, anxiety, fatigue, sleep disturbances, or impaired overall well-being.
The hypothesis is based on available data suggesting that the potential value of osteopathy in managing pain and functional disorders, and the patient's bodily experience and the value of hypnosis in managing anxiety and certain symptoms associated with cancer or its treatments.
Combining these two interventions could allow for a complementary approach addressing the physical, emotional, and cognitive dimensions of the patient's experience. Osteopathy could promote improved mobility, reduced tension, and better body awareness, while hypnosis could help modulate pain perception, reduce anxiety, and strengthen the patient's coping mechanisms regarding the disease and treatments.
Consequently, patients receiving this combined care are expected to show improvements in certain quality-of-life parameters, a reduction in pain intensity or impact, decreased stress or anxiety, and enhanced overall well-being. This study will explore these effects in a population of cancer patients while documenting the feasibility, acceptability, and perceived clinical value of this integrative intervention.
- Conditions
- Cancer
- Being tested
- Osteopathy, Hypnosis
- Keywords
- osteopathy, hypnosis, holistic approach, integrative medicine, cancer, cancer care, pain management, chronic pain, supportive care
- Medical subject headings
- Neoplasms, Agnosia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopathyBehavioural
An osteopathy session includes a health history chat, physical assessment, hands-on treatment, and aftercare advice.
HypnosisBehavioural
Hypnosis sessions consisted in deep relaxation and focused concentration, delivered by practitioners trained in the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy | Other | Patients assigned to this group will benefit from osteopathy sessions. Receives: Behavioral: Osteopathy |
| Osteopathy + Hypnosis | Experimental | Patients assigned to this group will benefit from supportive care combining osteopathy and hypnosis. Receives: Behavioral: Osteopathy; Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and quality of life
Change in pain and functional quality of life assessed between baseline (Day 0) and 6 weeks using the Brief Pain Inventory (BPI). • Calculation: The mean (average) of four items measuring pain in the last 24 hours or past week: worst pain, least pain, average pain, and current pain ("pain right now"). (Alternatively, a single item like "worst pain" can be evaluated on its own).
- Scale Range: 0 to 10 (0 = "no pain", 10 = "pain as bad as you could imagine"). Cut-offs: 0 - 3: Mild pain, 4 - 6: Moderate pain, 7 - 10: Severe pain
Measured: 6 weeks
Secondary outcomes (2)
Emotional distress variation
Change in emotional distress assessed at baseline, 6 weeks, and 1 month using the K10 psychological distress questionnaire (Kessler). Questions: 10 items.
Scale: Each item is rated on a 5-point Likert scale from 1 (none of the time) to 5 (all of the time). Total Score Range: 10 to 50 (calculated by summing all 10 responses).
.Results 10 - 15 (Low / Well): Little to no psychological distress; likely within normal limits. 16 - 21 (Moderate Distress): Mild to moderate levels of emotional strain or symptoms. 22 - 29 (High Distress): High level of psychological distress; may indicate a mild-to-moderate mental health disorder requiring attention or early intervention; 30 - 50 (Very High / Severe Distress): Severe psychological distress; strongly indicates a probable serious mental health condition and a need for professional evaluation or specialist referral.
Measured: 6 weeks
Patient's experience
Semi-structured qualitative questionnaire on the experience and perception of the combined treatment, administered one month after the final session
Measured: 1 month after final intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start30 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Rafael
- Sponsor type
- University, hospital or other
- Collaborators
- Hartmann Oncology Radiotherapy Group, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860476
- Sponsor's protocol ID
- IR-2025/0002
- Other IDs
- IDRCB 2026-A00565-46
- Acronym
- HYPOSTEO
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Psychological Evaluation of Combined Osteopathy and Therapeutic Hypnosis in Cancer Patients Living With Chronic Pain: a Randomized Study Comparing Osteopathy and Hypnosis With Osteopathy Alone.
- ClinicalTrials.gov ID
- NCT07860476
- Acronym / sponsor ID
- HYPOSTEO / IR-2025/0002
- Conditions
- Cancer
- Keywords
- osteopathy, hypnosis, holistic approach, integrative medicine, cancer, cancer care, pain management, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut RafaelUniversity, hospital or other
- Collaborators
- Hartmann Oncology Radiotherapy Group, France
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 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.
Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.
Combining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component.
Detailed description
While increasingly effective, cancer treatments are often accompanied by severe side effects, including chronic pain, fatigue, and reduced quality of life. Pain has often a strong emotional component, influenced by anxiety, stress, or the psychological distress inherent in the treatment journey.
Osteopathy is recognized as a beneficial complementary approach for cancer patients. By addressing tissue mobility, circulation, and muscle tension, it helps improve physical comfort, reduce musculoskeletal pain, and foster better functional recovery. Several studies have shown that osteopathy can help reduce pain intensity and improve the quality of life for patients undergoing cancer treatment.
However, pain with a strong emotional component may require a more holistic approach; osteopathy offers gradual benefits that can be optimized by combining it with other complementary therapies, such as hypnosis.
As a complementary therapy, hypnosis is increasingly used for pain and stress management in oncology. It works by modulating pain perception and reducing anxiety, thereby helping patients cope better with their symptoms.
Combining hypnosis with osteopathy could thus optimize treatment outcomes by integrating a holistic approach that addresses both physical and psychological needs. The aim of this study is to evaluate the impact of combined osteopathy and hypnosis treatment compared to osteopathic treatment alone in cancer patients, particularly regarding pain with a strong emotional component. This combined approach could represent a significant step forward in improving the well-being of oncology patients by offering care that is better suited to the multidimensional nature of pain.
This research combining osteopathy and hypnosis could help improve symptoms and quality of life of cancer patients, particularly those suffering from chronic pain, anxiety, fatigue, sleep disturbances, or impaired overall well-being.
The hypothesis is based on available data suggesting that the potential value of osteopathy in managing pain and functional disorders, and the patient's bodily experience and the value of hypnosis in managing anxiety and certain symptoms associated with cancer or its treatments.
Combining these two interventions could allow for a complementary approach addressing the physical, emotional, and cognitive dimensions of the patient's experience. Osteopathy could promote improved mobility, reduced tension, and better body awareness, while hypnosis could help modulate pain perception, reduce anxiety, and strengthen the patient's coping mechanisms regarding the disease and treatments.
Consequently, patients receiving this combined care are expected to show improvements in certain quality-of-life parameters, a reduction in pain intensity or impact, decreased stress or anxiety, and enhanced overall well-being. This study will explore these effects in a population of cancer patients while documenting the feasibility, acceptability, and perceived clinical value of this integrative intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathy | Other | Behavioral: OsteopathyPatients assigned to this group will benefit from osteopathy sessions. |
| Osteopathy + Hypnosis | Experimental | Behavioral: Osteopathy, Behavioral: HypnosisPatients assigned to this group will benefit from supportive care combining osteopathy and hypnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years,
- Patient diagnosed with cancer (currently undergoing treatment or having completed oncological treatment),
- Experiencing chronic pain (≥ 3 months),
- Presenting a strong emotional component to the pain: K10 score between 20 and 29,
- Patient able to attend all visits and follow study procedures,
Key exclusion criteria (4 listed)
- Patients with no emotional distress or with severe distress
- Sensory (auditory, visual) or cognitive deficits likely to hinder the conduct of hypnosis sessions
- Patient who has undergone hypnotherapy sessions within the last 3 months
- Patient unable to provide consent
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 |
|---|---|---|
| OsteopathyAn osteopathy session includes a health history chat, physical assessment, hands-on treatment, and aftercare advice. | Behavioural | Osteopathy, Osteopathy + Hypnosis |
| HypnosisHypnosis sessions consisted in deep relaxation and focused concentration, delivered by practitioners trained in the therapy. | Behavioural | Osteopathy + Hypnosis |
Primary outcome
Pain and quality of life
Time frame: 6 weeks
Change in pain and functional quality of life assessed between baseline (Day 0) and 6 weeks using the Brief Pain Inventory (BPI). • Calculation: The mean (average) of four items measuring pain in the last 24 hours or past week: worst pain, least pain, average pain, and current pain ("pain right now"). (Alternatively, a single item like "worst pain" can be evaluated on its own). • Scale Range: 0 to 10 (0 = "no pain", 10 = "pain as bad as you could imagine"). Cut-offs: 0 - 3: Mild pain, 4 - 6: Moderate pain, 7 - 10: Severe pain
2 secondary outcomes
Emotional distress variation
Time frame: 6 weeks
Patient's experience
Time frame: 1 month after final intervention
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 9 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathy and Hypnosis in people with Cancer, run by Institut Rafael 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 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 9 Oct 2026. 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 Alain TOLEDANO, M.D. (+ 33 (0)1 84 00 70 07, alain.toledano@horg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and quality of life (time frame: 6 weeks). 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 9 Oct 2026.