ClinicalTrials.gg
RecruitingNCT04940780Updated Apr 29, 2026

Integrative Oncology for Patient Symptoms

An interventional study of Acupuncture and Touch Therapies in Oncologic Complications and Symptoms and Signs, sponsored by Shaare Zedek Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.).

02

Conditions studied

  • Oncologic Complications
  • Symptoms and Signs

Browse trials for

Keywords

  • Integrative medicine
  • Integrative oncology
  • Acupuncture
  • Touch therapy
  • Wellbeing
03

In context

Signs and Symptoms

221 studies on the registry are indexed under Signs and Symptoms; 22 are open to participants now.

This study's planned enrollment of 750 is above the median of 78 across 152 interventional studies indexed under Signs and Symptoms.

Browse Signs and Symptoms studies →

Lead sponsor

Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age ≥ 18 years
  • undergoing active oncology treatment
  • fully understand the study plan
  • agree to sign the study form.

Exclusion criteria

Exclusion Criteria:

  • not fulfilling all of the study criteria
  • not interested in attending all 8 weekly CIM treatments sessions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
750 participants (estimated)

Study arms

  • Active comparator
    Patient Preference Arm - Acupuncture

    Patients who specify their preference for acupuncture

    Other: Acupuncture · Other: Touch Therapies

  • Active comparator
    Randomized Treatment Arm - Acupuncture

    Patients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1

    Other: Acupuncture

  • Active comparator
    Patient Preference Arm - Touch Therapy

    Patients who specify their preference for touch therapy

    Other: Acupuncture · Other: Touch Therapies

  • Active comparator
    Randomized Treatment Arm - Touch Therapy

    Patients with no preference to be randomly allocated to touch therapy (vs. acupuncture); ratio 1:1

    Other: Touch Therapies

Interventions

  • OtherAcupuncture

    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

  • OtherTouch Therapies

    Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

06

What researchers measure

Primary outcomes

  1. EORTC QLQ-C30 global health status / QoL scale

    Change from baseline to the end of the 8-week integrative treatment program

    Time frame: 8 weeks

Secondary outcomes

  1. EORTC QLQ-C30 global health status / QoL scale

    Change from baseline and 8-week assessment to 16 week follow-up

    Time frame: 16 weeks

  2. EORTC QLQ-C30 - additional outcomes

    Change in functional and symptom scores

    Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

  3. ESAS symptom severity scores

    Change in severity scores for 10 quality-of life related items

    Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

  4. MYCAW symptom severity scores

    Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives

    Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

  5. 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

    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.

  6. Adherence to conventional oncology treatment regimen

    Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation

    Time frame: At 16 weeks from baseline.

  7. Caregiver expectations

    Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

    Time frame: At baseline

07

Study locations

1 of 1 sites recruiting
  • Institute of Oncology, Shaare Zedek Medical Center
    Jerusalem, 7791031, Israel
    Recruiting
    • Noah Samuels, M.D. · Contactnoahs@szmc.org.il · 026666395
    • Nathan Cherny, M.D. · Sub investigator
08

References and documents

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 33588610 ↗
  • Samuels 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 32048067 ↗
  • Ben-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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Dec 2027, 73 months after the start.

Of 58 non-industry interventional studies with no phase under Signs and Symptoms, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 73 months is above that.

Counting every sponsor, half of 69 studies reached it within 17 months; a quarter within 6 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2021
First posted
Jun 28, 2021
StartActual
Nov 1, 2021
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04940780
Responsible party
Noah Samuels (Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center) — Principal investigator
First posted
Jun 28, 2021
Start date
Nov 1, 2021
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 29, 2026

Study contacts

Noah Samuels, M.D.
Contact
noahs@szmc.org.il
972-26666395

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion