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
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.).
Exclusion Criteria:
Patients who specify their preference for acupuncture
Other: Acupuncture · Other: Touch Therapies
Patients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1
Other: Acupuncture
Patients who specify their preference for touch therapy
Other: Acupuncture · Other: Touch Therapies
Patients with no preference to be randomly allocated to touch therapy (vs. acupuncture); ratio 1:1
Other: Touch Therapies
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 therapies are to include Reflexology, Shiatsu and Therapeutic Touch
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
EORTC QLQ-C30 global health status / QoL scale
Change from baseline and 8-week assessment to 16 week follow-up
Time frame: 16 weeks
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
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
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
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.
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.
Caregiver expectations
Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
Time frame: At baseline
Plan to share: No
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Shaare Zedek Medical Center