Complementary/Integrative Medicine for Brain Cancer Patients

NCT03185780 | Withdrawn

• 1 other identifier: ChaimShebaMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Nearly a quarter of a million patients are diagnosed each year with tumors of the central nervous system, a third of them malignant. The most common malignant tumor of the brain is the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor, followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation, weakness/fatigue, and others), with treatment of these effects limited in their effectiveness and safety. Complementary medicine treatments such as acupuncture and touch therapies (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for some of the toxic effects of oncology treatment regimens. The present pilot study is set to examine the impact of complementary medicine on the toxic effects of the conventional treatment for HGG. The study will include 40 patients and will last for two years, during which patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.

Conditions

Quality of Life; Chemotherapeutic Toxicity; Radiation Toxicity

Keywords

complementary/integrative medicine; glioblastoma; quality of life; adherence

Outcome Measures

Primary Outcomes (4)

• Measure Yourself Concerns and Wellbeing (MYCAW) study tool

  Patient-Reported Outcome Measure - Quality of Life Assessment

  6 months

• Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire

  Patient-Reported Outcome Measure - Quality of Life Assessment

  6 months

• Edmonton Symptom Assessment Scale (ESAS)

  Patient-Reported Outcome Measure - Quality of Life Assessment

  6 months

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30)

  Patient-Reported Outcome Measure - Quality of Life Assessment

  6 months

Secondary Outcomes (2)

• Adverse effects attributed to the complementary/integrative medicine treatments

  6 months

• RDI - relative dose intensity

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. These treatments will be administered twice-weekly during active chemo-radiation treatment (6 weeks), followed by once-weekly treatment throughout the remainder of the study period (6 months)

Other: Acupuncture

Interventions

Acupuncture OTHER

Acupuncture: the insertion of use of ultra-fine needles (diameter 0.18 - 0.30mm) into designated "acupoints" in the skin, along the limbs and trunk areas. Reflexology: The massage + application of localized pressure on designated points along the plantar aspect of the feet. Shiatsu: The application of localized pressure along designated points (similar to "acupoints") along the limbs and trunk areas.

Also known as: Touch Therapy - reflexology or Shiatsu

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient aged 18 years and older
• diagnosed with high grade glioma (stage III-IV)
• following surgical intervention (tumor resection)
• prior to chemo-radiation treatment
• signing of informed consent form

You may not qualify if:

• inability/unwillingness to sign informed consent form
• unwillingness of treating oncologist to allow participation in the study

Sponsors & Collaborators

• The Chaim Sheba Medical Center: lead

MeSH Terms

Conditions

Radiation Injuries; Glioblastoma

Interventions

Acupuncture Therapy; Acupressure

Condition Hierarchy (Ancestors)

Wounds and Injuries; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Study Officials

• Noah Samuels, MD

  Tal Center for Integrative Oncology, Institute of Oncology, Chaim Sheba Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Tal Center for Integrative Oncology, Institute of Oncology

Model Details: Patients with high grade glioma undergoing adjuvant (post-surgical) chemo-radiation treatment will be treated with acupuncture and/or touch therapies, this in parallel to their conventional treatment regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: July 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11