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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus

Criteria

Inclusion Criteria:

1. colon cancer patients receiving adjuvant treatment as described above after hysterectomy surgery.

2. stage II or III disease

3. age over 18 years.

4. functional status (PS) ≤ 2 (0-2 WHO performance status)

5. patients hospital Rambam Medical Center6. signing of the informed consent form

Exclusion Criteria:

1. patients taking psychiatric drugs because of depression, anxiety or another disorder that requires psychiatric intervention.

2. comorbidity that directly affects the immune indices (such as autoimmune diseases, immune deficiency)3. difficulty in understanding the Hebrew language-these patients can be included in the control group