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The Relationship Between Relaxation or Wheat Germ Juice to the Immune Indices and Quality of Life (QoL) in Colorectal Cancer Patients on Adjuvant Chemotherapy

NCT01991080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-05-08

No results posted yet for this study

Summary

The immune system plays an important role in the fight against cancer. According to certain studies, Levels of cytokines secreted by the immune cells were found as predictors of prognosis and survival among cancer patients, as well as disease recurrence. Previous studies, including meta-analyses, reported that chronic emotional stress or depression were associated with higher levels of pro-inflammatory cytokines. Practicing relaxation was found to decrease psychological symptoms among cancer patients, such as depression, anger, hostility and anxiety symptoms, as well as physical symptoms.

Wheatgrass juice is an extract squeezed from the mature sprouts of wheat seeds (Triticum aestivum). Currently, there are only a few laboratory and medical studies that examine the beneficial effects of wheatgrass consumption. Controlled clinical trials have found that wheatgrass juice may reduce chemotherapy-induced myelotoxicity, accompanied by fever and infection without harming the chemotherapy effectiveness among breast cancer patients6.

Aims

1. To examine the differences in immune measures (serum and micro-particles levels of the cytokines IL-6, IL-8, IL-10 and IL-12), and in physical and psychological well-being measures (anxiety, depression, pain, fatigue, nausea) at three time points and between two intervention methods (biofeedback-assisted relaxation and wheatgrass consumption) and between the intervention groups vs. a control group, among colorectal cancer patients.
2. To assess the mediating role of optimism, perceived control and well-being measures (anxiety, depression, pain, fatigue, nausea) among colorectal cancer patients in the relations between the interventions (biofeedback-assisted relaxation and wheatgrass consumption) and the immune measures (serum and micro-particles levels of cytokines IL-6, IL-8 IL-10 and IL-12 ), and the mediating role of well-being measures on the relations between optimism and perceived control with immune measures.

Methods Participants will include 120 colorectal cancer patients aged 18+, with Eastern performance status of ≤ 2 and disease stage II or III, who receive adjuvant chemotherapy of Capcitabine or FU-5 treatment, conjoined with Oxaliplatin, or Capcitabine alone following curative surgery at Rambam Health Care Campus. The estimated number of participants was calculated based on Green's equation (1991): 50+8X 7 A comparison between the two treatment groups, as well as a comparison between each treatment group and the control group (80 subjects) will allow inclusion of up to four background parameters in each of the regressions, according to Green's equation.

Conditions

Interventions

BEHAVIORAL

biofeedback

Patients will go through biofeedback sessions

DRUG

Wheatgerm juice

Patient will drink wheatgerm juice

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Gil Bar-Sela, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991080 on ClinicalTrials.gov