Oncologic ComplicationsNCT04940780
Integrative Oncology for Patient Symptoms
A study testing Acupuncture and Touch Therapies in people with Oncologic Complications and Symptoms and Signs, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Complications, Symptoms and Signs
- What is being tested?
- Acupuncture and Touch Therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2021to 31 Dec 2027
- 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
- undergoing active oncology treatment
- fully understand the study plan
- agree to sign the study informed consent form.
Who cannot join
- not fulfilling all of the study criteria
- not interested in attending all 8 weekly CIM treatments sessions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Institute of Oncology, Shaare Zedek Medical Center
Jerusalem, 7791031
Noah Samuels, M.D., 026666395, noahs@szmc.org.il
Nathan Cherny, M.D.
About this study
Official title: Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study
The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.
A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
- Conditions
- Oncologic Complications, Symptoms and Signs
- Being tested
- Acupuncture, Touch Therapies
- Keywords
- Integrative medicine, Integrative oncology, Acupuncture, Touch therapy, Wellbeing
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms
Touch TherapiesOther
Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch
| Study group | Role | What they receive |
|---|---|---|
| Patient Preference Arm - Acupuncture | Active comparator | Patients who specify their preference for acupuncture Receives: Other: Acupuncture; Other: Touch Therapies |
| Randomized Treatment Arm - Acupuncture | Active comparator | Patients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1 Receives: Other: Acupuncture |
| Patient Preference Arm - Touch Therapy | Active comparator | Patients who specify their preference for touch therapy Receives: Other: Acupuncture; Other: Touch Therapies |
| Randomized Treatment Arm - Touch Therapy | Active comparator | Patients with no preference to be randomly allocated to touch therapy (vs. acupuncture); ratio 1:1 Receives: Other: Touch Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30 global health status / QoL scale
Change from baseline to the end of the 8-week integrative treatment program
Measured: 8 weeks
Secondary outcomes (7)
EORTC QLQ-C30 global health status / QoL scale
Change from baseline and 8-week assessment to 16 week follow-up
Measured: 16 weeks
EORTC QLQ-C30 - additional outcomes
Change in functional and symptom scores
Measured: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
ESAS symptom severity scores
Change in severity scores for 10 quality-of life related items
Measured: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
MYCAW symptom severity scores
Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives
Measured: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
Frequency of adverse effects
Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention
Measured: At the end of the series of 8 weekly CIM treatment sessions (≤ 2 weeks after the last treatment session); after 16 weeks from baseline.
Adherence to conventional oncology treatment regimen
Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation
Measured: At 16 weeks from baseline.
Caregiver expectations
Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oncologic ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient-preference, pragmatic methodology
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Samuels, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940780
- Sponsor's protocol ID
- INTEGR.ONCOL.REGIST-2021
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samuels N, Oberbaum M, Ben-Arye E. Expectations of Patients and Their Informal Caregivers from an Integrative Oncology Consultation. Integr Cancer Ther. 2021 Jan-Dec;20:1534735421990080. doi: 10.1177/1534735421990080.
PubMed 33588610Samuels N, Ben-Arye E. Integrative Approaches to Chemotherapy-Induced Peripheral Neuropathy. Curr Oncol Rep. 2020 Feb 11;22(3):23. doi: 10.1007/s11912-020-0891-2.
PubMed 32048067Ben-Arye E, Dahly H, Keshet Y, Dagash J, Samuels N. Providing integrative care in the pre-chemotherapy setting: a pragmatic controlled patient-centered trial with implications for supportive cancer care. J Cancer Res Clin Oncol. 2018 Sep;144(9):1825-1833. doi: 10.1007/s00432-018-2700-y. Epub 2018 Jul 6.
PubMed 29980837
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study
- ClinicalTrials.gov ID
- NCT04940780
- Acronym / sponsor ID
- INTEGR.ONCOL.REGIST-2021
- Conditions
- Oncologic Complications, Symptoms and Signs
- Keywords
- Integrative medicine, Integrative oncology, Acupuncture, Touch therapy, Wellbeing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jun 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.
The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.
A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patient-preference, pragmatic methodology
| Arm | Type | Receives |
|---|---|---|
| Patient Preference Arm - Acupuncture | Active comparator | Other: Acupuncture, Other: Touch TherapiesPatients who specify their preference for acupuncture |
| Randomized Treatment Arm - Acupuncture | Active comparator | Other: AcupuncturePatients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1 |
| Patient Preference Arm - Touch Therapy | Active comparator | Other: Acupuncture, Other: Touch TherapiesPatients who specify their preference for touch therapy |
| Randomized Treatment Arm - Touch Therapy | Active comparator | Other: Touch TherapiesPatients with no preference to be randomly allocated to touch therapy (vs. acupuncture); ratio 1:1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- undergoing active oncology treatment
- fully understand the study plan
- agree to sign the study informed consent form.
Key exclusion criteria (2 listed)
- not fulfilling all of the study criteria
- not interested in attending all 8 weekly CIM treatments sessions
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 |
|---|---|---|
| AcupunctureAcupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms | Other | Patient Preference Arm - Acupuncture, Patient Preference Arm - Touch Therapy, Randomized Treatment Arm - Acupuncture |
| Touch TherapiesTouch therapies are to include Reflexology, Shiatsu and Therapeutic Touch | Other | Patient Preference Arm - Acupuncture, Patient Preference Arm - Touch Therapy, Randomized Treatment Arm - Touch Therapy |
Primary outcome
EORTC QLQ-C30 global health status / QoL scale
Time frame: 8 weeks
Change from baseline to the end of the 8-week integrative treatment program
7 secondary outcomes
EORTC QLQ-C30 global health status / QoL scale
Time frame: 16 weeks
EORTC QLQ-C30 - additional outcomes
Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
ESAS symptom severity scores
Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
MYCAW symptom severity scores
Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
Frequency of adverse effects
Time frame: At the end of the series of 8 weekly CIM treatment sessions (≤ 2 weeks after the last treatment session); after 16 weeks from baseline.
Adherence to conventional oncology treatment regimen
Time frame: At 16 weeks from baseline.
Caregiver expectations
Time frame: At baseline
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 29 Apr 2026.
- Background: PubMed 33588610Samuels N, Oberbaum M, Ben-Arye E. Expectations of Patients and Their Informal Caregivers from an Integrative Oncology Consultation. Integr Cancer Ther. 2021 Jan-Dec;20:1534735421990080. doi: 10.1177/1534735421990080.
- Background: PubMed 32048067Samuels N, Ben-Arye E. Integrative Approaches to Chemotherapy-Induced Peripheral Neuropathy. Curr Oncol Rep. 2020 Feb 11;22(3):23. doi: 10.1007/s11912-020-0891-2.
- Background: PubMed 29980837Ben-Arye E, Dahly H, Keshet Y, Dagash J, Samuels N. Providing integrative care in the pre-chemotherapy setting: a pragmatic controlled patient-centered trial with implications for supportive cancer care. J Cancer Res Clin Oncol. 2018 Sep;144(9):1825-1833. doi: 10.1007/s00432-018-2700-y. Epub 2018 Jul 6.
- 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 Acupuncture and Touch Therapies in people with Oncologic Complications and Symptoms and Signs, run by Shaare Zedek Medical Center at 1 site in Israel.
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 2 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 29 Apr 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 Israel. 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 Noah Samuels, M.D. (972-26666395, noahs@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-C30 global health status / QoL scale (time frame: 8 weeks). 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 NCT04940780, which also lists 3 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 29 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.