The Effect of Ganoderma on Patients With Head-and-neck Cancer

Not Applicable

• Conditions: Head-and-neck Cancer

• Registration Number: NCT02238587
• Lead Sponsor: Chang Bing Show Chwan Memorial Hospital

Brief Summary

To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

Detailed Description

Ganoderma is known to modulate immunity and improve health. However, the mechanism is not clear. We hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as Ganoderma to improve life quality and immunity status.

A total of 100 patients are randomized to study and control groups. In study group, Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos are given during the same period. Then the patients in study and control groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)

Exclusion Criteria

• Patients with head-and-neck cancer under treatment or within 3 months after treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Immune modulation such as tumor necrosis factors-α or interleukin-6	Change from baseline in cytokines at 6 months	Subjects will be assigned to receive placebo/Ganoderma or Ganoderma Spores Powder Capsules twice a day for 12 weeks. Peripheral blood and saliva will be collected at 3 different times: (1)baseline data: before oral intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention.

Secondary Outcome Measures

Name	Time	Method
Life quality	Change from baseline in life quality at 6 months	Health and life quality will assessed by Quality of Life Questionnaire at three different times: (1)baseline data: before intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention.

Trial Locations

Locations (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital; 🇨🇳 Changhua County, Taiwan

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

🇨🇳Changhua County, Taiwan

Kuender D. Yang, PhD

Contact

886-975617006

yangkd.yeh@hotmail.com